5 Case Form

This chapter provides information about the Case Form section of the Argus Safety user interface.

Case Form Functions

The Case Form enables you to do the following:

Enter case-specific information
Log preliminary information about cases

The Case Form has the following tabs:

General Tab
Patient Tab
Products Tab
Events Tab
Analysis Tab
Activities Tab
Additional Info Tab
Regulatory Reports Tab

Each tab enables you to capture specific information about the case and is designed to capture similar information in each of its subsections.

Note:

Some sections in each tab enable you to make multiple entries. For example, you can have more than one reporter in the Reporter Information section of the General tab. Each individual entry is identified by another set of tabs in the section.

All tabs of the Case Form also display read-only information about case priority and status.

To access the Case Form

Search for an existing case.
When the application displays the search results, locate the appropriate case number and click the case number link.
The system opens the Case Form with information about the case.

Case Form Features

The case form provides features to help you use it more effectively.

General Case Form Usage Information

When using the Case Form, be aware of the following:

The maximum number of Products and Events is 200 per case.
The drop down values for elements such as Yes/No/Unk is not hard coded. The system retrieves the values from a look-up table. This affects the following:
- Reporter Information | HCP
- Device Information | Improper usage/Storage Field
The system defaults to the first button on every message box pop up dialog. When the user clicks Enter or the space bar, the system validates the choices.
The user can enter a hyperlink (e.g. http://www.oracle.com and https://www.oracle.com) in the Field Label Help for the Case Form Fields
When the user clicks a hyperlink, the system opens the link in a new Internet Explorer browser window.
The following Case Form fields are type ahead fields:
- Contact Logs | Group and Users
- Action Items | Groups and Users
The WHO Drug browser displays the WHO Drug Version on the browser dialog. The browser dialog is configured in System Configuration | Case Form Configuration.
Users can enter decimal numbers with up to three (3) decimal places in the UDF Number fields on all tabs. If the user does not enter a decimal, the system does not display trailing zeroes.

Using Password Acceptance Dialog Boxes

The system displays the User Name in read-only mode in following dialog boxes where the user must enter a password to start processing:

Activities Tab: Case Lock/Unlock
Activities Tab: Case Archive/Un-Archive
General Tab: Unblind Case
E2B Acceptance/Rejection for Initial, Follow-up, and Notification
Affiliate Acceptance/Rejection of Events
Case Actions: Delete/Undelete

Initial Case Entry

When using the BookIn dialog box, be aware of the following:

You can enter the attachment classifications and their descriptions on the Initial Case entry dialog.
The field labels are the same as those defined in the Field Labels and the Case Form
- The lengths for the Classifications type ahead field and the Description field are the same as those on the Additional Info tab
- The system filters classifications by user sites and the attachment classifications permissions.
- When you select the URL Reference, the system hides the Classifications and Description fields.
The system transfers the values the user enters in the Classifications and Description fields after the cases have been booked in.
If the system does not find any cases during a duplicate search, it places the following message in the search results section: No cases found.
When you try to book in a clinical trial case and select a study where the country of incidence value does not match the list of countries defined in the study configuration, the system displays the following warning message in the standard Argus Safety warning message dialog box:

The country of incidence does not match the country list specified for the selected study.
- If no countries are specified in the study configuration for the selected study, the warning message does not display.
- If the user selects the study before entering the COI, the system performs the validation
The user can right click on the row and select the following:
- Case Summary -- The system displays the Case Summary (Current functionality).
- Print Medical Summary -- The system displays the Medical Summary report PDF only if the user has access to the Medical Review dialog box. If the user does not have access, the system hides the Medical Summary Report option.
- Print -- The system launches the Case Form print dialog box. If the user has permission to access the Print Case dialog, the user can print the Case Form. If the user does not have access to the Case Form print dialog box, the system hides the Print Case option.

Zoom Function

The Zoom feature enables you to increase or decrease the font size of the text.

Click the Zoom icon across the Case Form tabs.
The Zoom dialog enables you to increase or decrease the Font Size of the text on the Zoom dialog.
Click Adjust Font Size to increase or decrease the font size.
- Click + to increase the font size up to five (5) font sizes in one-size increments.
- Click - to decrease the font size to the current by increments of 1.

This feature is available on the following dialogs:

Reporter Notes
Patient Notes
Patient Other Relevant History Notes
Patient Lab Data Notes
Patient Relevant Test
Parent Medical History
Parent Other Relevant History Notes
Product Notes
Case Analysis: Narrative. This is also available on the Medical Review Dialog.
Case Analysis: Abbreviated Narrative. This is also available on the Medical Review Dialog.
Case Analysis: Company Comment. This is also available on the Medical Review Dialog.
Case Analysis: Local Evaluator Comment. This is also available on the Medical Review Dialog.
Case Analysis: Administrative Notes. This is also available on the Medical Review Dialog.
Case Analysis: Evaluation in light of similar events in the past. This is also available on the Medical Review Dialog.
AffSAPS: Future Actions.
Activities: Contact Log Description.
Activities: Action Item Description. This is also available on the Medical Review Dialog.
Activities: Routing Comments
Notes and Attachments: Description

Case Form Drop-down Options

The Case form for the following fields includes Type Ahead functionality. This feature automatically suggests possible options as term names as you are entering the text. If you double-click on the field, the system shows the standard drop-down values for the field.

The following is a list of fields with type ahead functionality:

Accidental Exposure
Action Taken
Action Type
Age Groups
Age Units
Anatomical Locations
Attachment Classification
Attachment Keywords
Birth Type
Case Classification
Causality Category
Condition Type
Contact Type
Delivery Types
Device Preliminary Comments
Device Subcomponents
Device Type
Dosage Frequency
Dosage Units
Evaluation Reason
Event Frequency
Event Intensity
Event Outcome
Fetal Outcome
Formulation
Gender
Intermediary
Lab Result Assessment Terms
Lab Test Type
Manufacturers
Occupations
Package Units
Reference Type
Report Media
Report Type
Reporter Type
Routes of Administration
Study Center

Argus Safety Case Form User Preferences

Argus Safety remembers your actions as you navigate through the Case Form.

The system can return to the same location on the tab after you tab to a different form. For example, you are on the 8th reporter in the Reporter Section on the General tab and move to another location in the application. When you return to the General tab, the system takes you directly to the 8th Reporter because it was the last Case Form location that you accessed before moving out of the Case Form.

User preferences are only applicable during the same session for a case, irrespective of the Case Status (read-only or editable). If you exit from the case and open a new case, the system resets the preferences.

Quick Navigation

Each page displays the navigation flow used to access the page. The following table lists shortcut keys to help you navigate more easily and quickly.

Shortcut Key	Output
CTRL+SHIFT+#	Goes to the tab indicated by the # entered. (1=General tab, 2=Patient tab, etc.)
ALT+SHIFT+#	Goes to the sub-tab as indicated by the # entered (= Product 1, Product 2, etc.)Note: The maximum # for the sub entities is 10 which pertains to ALT+SHIFT+1 for the first entity within the tab till ALT+SHIFT+0 for the 10th entity within the tab.

General Tab

The General tab is designed to capture case information in categorized sections that capture category-specific information. The General tab enables you to enter or view information such as type of report, literature information, and so forth.

The General tab has four sections as described in the following table.

Section	Purpose
General Information	Contains information about the report type, receipt dates, etc.
Study Information	Contains information about clinical trial details, if appropriate.
Reporter Information	Contains information about Reporter details.
Literature Information	Contains information about Literature cases.

General Usage Information

When using the General Tab be aware of the following:

The system saves all filtering criteria the user enters on the Reporter Look Up dialog as user preferences while it populates the reporter information on the General Tab.
- If you have reporter information in the case, the system continues to display the reporter information in the Reporter Lookup dialog and automatically performs a search.
- After performing the search the system retains the search criteria as user preferences. The next time you perform a search, the system displays these preferences.
- When you log out, the system retains the user preferences and makes them available the next time you log in to the system
- You can click Clear to clear all the values in the filtering elements.
- If the system cannot find any reporters during a search, it displays the following message in the reporter look up dialog:
  
  No reporters found

If a priority has not been assigned to a case, the system hides the Case Priority field label.
If a case owner has been assigned to the case, the system displays the name of the case at the top of the Case form. If a case owner has not been assigned, the system hides the Case Owner label.
The Project ID can be 40 characters long. Users can scroll in the field.
The Study Name field can be 70 characters long.
When the Classifications field is hidden, the system does not display the classification section on the Case Form.
The mandatory fields identified in the E2B Mapping in the factory or custom profiles are identified with an icon on the Case Form fields on the Case From and Medical Review dialog boxes.
All popup message boxes that had only an OK or Cancel button have a Clipboard button that enables you to copy the message content to the clipboard for later use.

Dynamic Workflow Indicators

Dynamic workflow indicators track the amount of elapsed time it takes to complete a workflow step.

The first number represents the time left or exceeded for a given workflow step
The second number indicates the time left till the reporting deadline.
Time is expressed in days (d), hours (h), and minutes (m) respectively.

The icon changes based on the amount of elapsed time for the workflow step.

Icon	Denotes
Traffic Light	No status can be indicated, for example if no timing is defined in the workflow.
Red Traffic Light	The timing has been exceeded.
Yellow Traffic Light	The timing is in danger of being exceeded.
Green Traffic Light	The timing is in good standing.

If the time to complete the case process exceeds the allocated time, the system displays the value in red with the time displayed as a negative value. Only archived, locked cases do not display the dynamic workflow indicator.

General Information

This part describes the General Information section on the General tab.

General Information Fields

The following table lists and describes the fields in the General Information section.

Field/Control Name	Description
Report Type	Select the item that best describes the type of report. Choice of report type determines availability of fields relating to clinical studies and/or literature references. Note: Clinical study reports prompt the user for information relating to the study, and literature-based reports enable the user to select the journal and reference on which the case is based.
Country	Select the country where the adverse event occurred. The E2B icon identifies fields required for E2B.
Initial Receipt Date	Enter the date your company became aware of the case. Argus Safety uses this date throughout all reports. Note: This date can be changed only prior to regulatory report submission.
Central Receipt Date	Enter the date on which this information was received by Central Safety.
Medically Confirm	Specify whether the case was medically confirmed or not, by a healthcare professional.
Initial Justification	Enables you to enter the initial justification reason. The entry in this field is displayed as per the reason entered when the case is being booked in.
Amendments/Follow-ups	The number automatically increments when a new record is added to the Amendment/Follow-up section. Note: On sorting by Follow-up received dates, the serial number still displays the order of entering the follow-ups. The follow-up information can be sorted by Serial Number, Follow-up Received date and Central Received Date Columns. Click on the header to sort in ascending order or to sort in descending order. By default, the sorting is in descending order of the Follow-up Received Date.
Follow-up Received Date	Click Add to enter the date on which amendment/follow-up information was received by your company. You can select whether the case has significant follow-up information by confirming the message: 'Is this follow-up significant?'. Note: If you select Yes, the Significant checkbox is selected and the Amendment checkbox is enabled. When sorting on follow-ups, by default, the dates are sorted in descending order of the Follow-up Received Date.
Safety Received	Enter the date on which follow-up information was received by Central Safety. This field is disabled for an amendment and any prior data in this field is cleared.
Significant	Click the checkbox if the follow-up is significant. This checkbox is automatically marked and disabled if the Amendment checkbox is checked.
Data Clean up	Click the checkbox to mark the Follow up as a Data Clean up version. This version is used in the Data Lock Point for Case Versioning in and System Reports. This field is disabled for an amendment and any prior data in this field is cleared.
Amendment	Enables you to specify if the case was updated with a significant change without adding any new information. The Follow-up Received Date is populated with the previous aware date and is disabled for an amendment.
Amendment/Follow-up Justification	Enables you to select a pre-defined justification for Amendment/Follow-up. Click the icon to view the standard justifications dialog. The justification entered in the Amendment field is also populated in this field. You can select a pre-defined justification from this dialog or enter a new justification.
Case Requires Follow-up	Select this checkbox if the case requires follow-up information.
Classification	Select up to 50 case classifications used to categorize a case. Click Add to enter additional case classifications.

Study Information

The Study Information section enables you to enter information about case studies.

Study Information Fields and Field Descriptions

The following table lists and describes the fields in the Study Information section.

Field/Control Name	Description
Project ID	Enter the Project ID, or select one from the list. Selecting a Project ID automatically creates items in the Study ID list.
Center ID	Select the appropriate center ID from the list.
Study Phase	Enables you to enter the Study Phase for the configured study. Note: This field is pre-populated if you select a Study with an already-configured Study Phase.
Study Name	The study name is entered automatically based on the study that is selected.
Study Type	The study type is entered automatically based on the study that is selected.
Week #	Enter the week number of the study during which the adverse event occurred.
Visit #	Enter the visit number of the study during which the adverse event occurred.
Blinding Status	Depending on the type of study, this item is entered automatically by the system. You need special access rights to use any of the Broken By entries. Note: The Unblind Case dialog appears when you try to unblind a study. For Not Blinded studies, saving the case or generating a report, you can enter the actual drug (vs. placebo) given to the patient.
Study Description	The study description is entered automatically based on the study that is selected.
Observe Study Type	The value selected from this drop-down list is populated in the Case Form Study Section when the Clinical Study is selected.
Unblinding Date	This item is automatically entered by the system when the blinding status is changed to 'Broken by Sponsor' or 'Broken by Investigator'. If you double-click the date in this item, the Unblind Case dialog is displayed. If the date of unblinding is more recent than the date for the most significant follow-up information, an automatic follow-up is generated. Unblinded date is not editable in the Unblind case dialog when blinded status is changed to 'Broken by Sponsor' whereas it is editable when the blinded status is changed to 'Broken by Investigator'.

Study Restrictions

To enter pre-defined Study Information

Click Select to choose from the already available list of study information.
When the Clinical Trial Selection dialog opens, enter Project, Study, and Center information as appropriate.

The Clinical Trial Selection dialog allows you to select a clinical trial from the list configured by the Administrator.
Click Search to generate the search results.

Tip:
To broaden the search results, enter as little information as possible. Select the required clinical study and study center and click Select.
Choose the appropriate study information from the list and click Select.
The details of the selected Study Information are added to each field in the Study Information section

Reporter Information

The Reporter Information section enables you to enter information about the person providing the case-related information. The following is an illustration of the Reporter Information section.

Surrounding text describes reporterinfor.jpg.

When using this section, be aware of the following:

The Reporter Rearrangement dialog also shows the number of Reporters present in the case. It displays the First Name and Last Name, followed by the Reporter Type in brackets, as entered in the reporter information dialog.
You can also view all the Reporters by clicking the Quick Launch icon.
Click any Reporter Name to view the details of the selected Reporter tab.
Click the New tab to add a new reporter anytime. You can add a maximum of 100 reporters.
The Primary Reporter is identified by the Reporter icon on the Reporter Information tab.

Reporter Information Fields

The following table lists and describes the fields in the Reported Information section.

Field/Control Name	Description
Reporter Notes	Click this button to enter free text notes relating to this reporter. Note: This field supports multiple language entry. You can click on a flag, select the language tab, and enter information.
Sal.	Enter the reporter's salutation.
First Name	Enter the reporter's first name.
Middle Name	Enter the reporter's middle name.
Last Name	Enter the reporter's last name. The Select button displays the Reporter Selection dialog. If you select a reporter from this dialog, the system automatically completes the case form reporter fields.
Suffix	Enter the reporter's suffix; for example, HR, or MED.
Health Care Professional	Select Yes, No, or Unk (Unknown) to indicate whether the reporter is a health-care professional.
Occupation	Select the reporter's occupation from the list.
Report sent to Regulatory Authority by Reporter?	Make a selection, as appropriate to the case.
Address 1	Enter line 1 of the reporter's address.
Address 2	Enter line 2 of the reporter's address.
Institution	Enter the reporter's institution.
Institution ID	Enter the reporter's institution ID. This field value is populated based on the Institution ID selected for the Reporter from the Reporter Lookup dialog. This field also allows manually entered/updated value directly in the Case Form irrespective of the value specified in the Institution field for the reporter. Manually entered Institution and institution ID field values are allowed in the Reporter Information section even if they are not specified / linked to each other as per Console Institution code list.
Department	Enter the reporter's department.
City	Enter the reporter's city.
Protect Confidentiality	If this check box is selected, the name and address of the reporter do not appear on regulatory reports and the reporter's information displays "NAME AND ADDRESS WITHHELD". The system also displays 'MSK' null flavor in the eVAERS report when this checkbox is checked. MSK is populated only when the data element contains some data and is not null.
Primary Reporter	Identifies the primary reporter. Only one primary reporter is permitted per case. The primary reporter is the reporter whose name appears on the regulatory reports. The tab that identifies the primary reporter is displayed in blue as compared to the other reporter tabs.
Correspondence Contact	If this check box is selected for a reporter, the reporter's address information is used in letters. You can select more than one reporter as the correspondence contacts for the case.
State	Enter the reporter's state.
Postal Code	Enter the reporter's postal code.
County	Enter the reporter's county.
Country	Select the country name. The Administrator maintains this list.
Phone Number	Enter the reporter's telephone number.
Alternate Phone	Enter another telephone number for the reporter, if available.
FAX Number	Enter the reporter's fax number.
Reporter ID	If known, enter the Reporter ID. This automatically completes the Case Form reporter fields.
Reporter's Reference #	Enter the Reporter's Reference # for the case.
Email Address	Enter the reporter's email address.
Reporter Type	Select the Reporter Type. The Administrator maintains this list.
Report Media	Select the medium of the report. The Administrator maintains this list.
Intermediary	If appropriate, select the type of intermediary. The Administrator maintains this list.
(New) Tab	New) Tab Creates details for a new reporter.

Adding Reporter Information

You can add reporter information by clicking the Select button and entering data in the Reporter Lookup dialog box.

To add reporter information

Click Select in the Reporter Information section.
When the system opens the Reporter Lookup dialog box, enter the required search criteria in the fields and click Search.

Tip:
You can choose to search either by Search Cases or by Search List Maintenance.
The Search results for the entered search are displayed.
When the system displays the search results, choose the appropriate reporter information from the list and click Select.
The system adds the selected, pre-defined information to the fields in the Reporter Information section.

Reporter Lookup Dialog Box Fields

The following table lists and describes the fields in the Reporter Lookup dialog box.

Field/Control Name	Description
First Name	Enter the first name of the reporter.
Last Name	Enter the last name of the reporter.
Reporter ID	Enter the ID of the reporter.
Institution	Enter the institution of the reporter.
Institution ID	Enter the institution ID of the reporter.
MR	Select this button if the reporter is a Medical Representative (MR).
Physician	Select this button if the reporter is a Healthcare Physician.
Department	Enter the department of the reporter.
Reporter Type	Enter the reporter type.
Address 1	Enter line 1 of the reporter's address.
Address 2	Enter line 2 of the reporter's address.
City	Enter the city of the reporter.
State/Province	Enter the state/province of the reporter.
Postal Code	Enter the postal code of the reporter.
Phone Number	Enter the phone number of the reporter.
County	Enter the reporter's county.
Country	Enter the country of the reporter.
Search Cases	Click this button to search for cases that match the specified search criteria.
Search List Maintenance	Click this button to search the list maintenance for the specified criteria.

Literature Information Section

This section enables you to enter a literature reference for the case. You can enter the information manually or you can enter pre-defined literature information by clicking the Select button and selecting from the list of pre-defined references.

Surrounding text describes literatureinfo.jpg.

Click the Quick Launch icon to view all the items present in the case. This information appears in the format: (Journal Name Yea Vol: Pages)

Surrounding text describes literaturelist.gif.

Literature Information Fields and Field Descriptions

The following table lists and describes the fields in the Literature Information section.

Field/Control Name	Description
Author	Enter the name(s) of the author(s) of the article.
Year	Enter the year in which the article was published.
Digital Object Identifier	Enter the digital object identifier of the article.
Select	Selects a literature reference directly from the list of literature articles entered by the Administrator. Note: If the required literature article is not present in the list, details of the article can be entered by using the remaining fields in the section.
Title	Enter the title of the article.
Volume	Enter the volume of the particular journal.
Journal	Enter the name of the journal in which the article appeared. This value gets displayed in italics.
Pgs	Enter the journal page numbers in which the article appears.

To enter pre-defined literature information

Click Select to choose from the already available list of literature information.
When the Literature Reference dialog opens, locate and select the appropriate reference in the list and click Select.
The details of the selected literature information are added to each field in Literature Information.

Patient Tab

This section of the Case Form helps you to enter patient information such as the patient's past medical history and current conditions, and laboratory tests and test results. The medical information entered here could be very useful to the person analyzing the event. For example, if the adverse event was a rash that developed after applying a topical product, the knowledge that the patient has a history of allergic reactions could be relevant.

Surrounding text describes patienttab.jpg.

The Patient tab includes the following tabs: Patient and Parent.

Patient Tab
Parent Tab

The Patient Tab

Patient Information

The Patient tab includes the following sections:

Patient Information
Patient Details
Event Death Details
Other Relevant History
Lab Data
Relevant Tests Section

Surrounding text describes patientinfo.jpg.

Patient Information Fields

The following table lists and describes the function of each field.

Field/Control Name	Description
Address 1	Enter the patient's line 1 address.
Address 2	Enter the patient's line 2 address.
Child only Case	If this check box is selected, then the pregnancy [Detail] button is accessible from the Parent information tab only and no longer through the Patient tab directly.
City	Enter the patient's city.
Country	Select the country. The Administrator can adjust this list.
County	Enter the patient's county.
Current Medical Status	Captures details about the history and the current condition of the patient from the dialog. Note: The items that appear in the Current Medical Status dialog automatically map to the fields for the German BfArM tab on the Analysis tab. Changing the values on the BfArM tab does not affect these items.
Email Address	Enter the patient's email address.
First Name	Enter the first name of the patient. Note: During book-in, the system transfers the appropriate patient name to the relevant name and initials fields. If the Patient Name or Initials are three characters or less, this is transferred to the Initials field.
Initials	Enter the patient's initials. Existence of the patient's first, middle, or last name automatically populates this field.
Last Name	Enter the last name of the patient.
MI	Enter the middle initial of the patient.
Number of Patients	Enter the number of patients involved in the adverse event.
Pat. ID	Enter the Patient Identifier number. Note: This field appears for clinical trial cases only. Tip: This field can be used while searching for cases in the Case Selection dialog.
Phone Number	Enables you to enter the phone number of the patient.
Postal Code	Enter the patient's postal code.
Protect Confidentiality	If this check box is selected, the patient's name and address will not appear on any of the regulatory reports and the patient's information will show the word PRIVACY. The system also displays 'MSK' null flavor in the eVAERS report when this checkbox is checked. MSK is populated only when the data element contains some data and is not null.
Randomization #	Determines which drug was administered to the patient during the course of the study. Note: This field appears for clinical trial cases only. Tip: This field can be used while searching for cases in the Case Selection dialog.
Sponsor Identifier	Enter the Sponsor Identifier of the patient. Note: This field appears for clinical trial cases only. Tip: This field can be used while searching for cases in the Case Selection dialog.
State	Enter the patient's state.
Title	Enter the title of the patient.

Patient Notes

Click to enter free text notes relating to the Patient. If there is no text data for Patient Notes, the Null Flavor can selected using the NF drop-down list.

Note: This field supports multiple language entry. You can click on a flag icon to enter data in different languages.

Icon is displayed when there is no data in Patient Notes and NF data.

Icon is displayed when there is data in Patient Notes or NF data.

Entering Current Medical Status

Use the following procedure to enter information about the patient's current medical status.

Click Current Medical Status in the Patient tab of the Case Form.
The Current Medical Status form opens as a pop-up.
Select the choices that apply to the patient from the items in the form.

If you don't know whether a particular condition applies for the patient, select Unk.
Click OK to save the current medical status.

Copying Patient Information from Reporter Information

If the patient and the reporter are the same person, the reporter information entered in the General tab can be copied to the Patient tab.

Click Patient Info From Reporter in the Patient tab to copy the reporter information. The reporter information is copied.

Patient Details

The Patient Details section enables you to enter information, including pregnancy data, about a patient. The following is an illustration of the Patient Details section.

Surrounding text describes patdetails.gif.

Patient Details Fields and Field Descriptions

The following table lists and describes the fields in the Patient Details section.

Field/Control Name	Description
Date of Birth	Enter the patient's date of birth. You can enter a partial date if the actual date is unavailable.
Age	Calculates the patient's age, from the date of birth and earliest event onset date, if both full dates are available; otherwise, you can enter the age manually.
Units	Select the age units. (i.e., days, weeks, months, years) Note: If both the date of birth and event onset date are available, the Age Units field is automatically calculated. The Administrator can adjust this list.
Age Group	Select an age group. If the age group is entered manually, the Age and Age Units fields are disabled. The Administrator can adjust this list. Note: This field is automatically filled in when the Age and Age Units fields are both entered.
Height	Enter the patient's height.
Height Units	Select the appropriate height unit.
Weight	Enter the patient's weight.
Weight Units	Select the appropriate weight unit.
Concomitant Therapy Administered	Check this box, if the patient is treated with concomitant therapies such as Physiotherapy, Radiotherapy.
Gender	Select the patient's gender. Note: If the patient is male, the system automatically disables the Pregnancy field. When the Gender is set to Female, the Pregnancy drop down is enabled and set to Unknown.
Pregnant	Make the appropriate selection. Note: If Yes is selected, a Details button will appear. Click Details to enter pregnancy information.
Date of LMP	Enter the date of the Last Menstrual Period, if applicable. A partial date can also be entered.
Breastfeeding	Select the checkbox, if applicable.
Occupation	Select the patient's occupation. The Administrator can adjust this list.
Age at Vaccination	Enter the patient's age at the time of vaccination.
Units (at vaccination)	Enter the age units (for example: days, weeks, months, and years) at the time of vaccination.
Ethnic Group	Enter the patient's ethnic group such as Hispanic or Latino, Not Hispanic or Latino, and so on.
Military Status	Enter the details of the Military status of the Patient such as Active Duty, Reserve, National Guard, TRICARE Beneficiary, and so on.
Race	Select the patient's race. You can capture up to 5 Race using the Add and Delete buttons. Note: The system does not let you select the same Race more than once. If you try to select the same Race again, an error message appears.

Entering Pregnancy Information -

Use the following procedure to enter pregnancy information.

Select Yes from the Pregnant drop-down list, if applicable.

This field is shown as active only after the Gender field in this section is selected as Female.

The Pregnancy Information section is displayed.
Enter the available pregnancy information in the form.
Click OK to save the pregnancy information.

The following lists and describes the fields on the Pregnancy Information and Neonate form.

Field/Control Name Name	Description
Due Date	Enter a due date or an approximate due date, if known.
Gestation Period	Enter the gestation period when the reaction / event was observed in the foetus. Select a unit for the gestation period from the accompanying drop-down list.
Number of Fetus	This tab allows entry of data for a baby who is born to the patient. Click New to make an additional entry.
Prospective/Retrospective	Select if the information was Prospective or Retrospective. Note: A prospective information is one where the company hears of the case before the baby is born to the patient who took the drug. In a retrospective case, a company gets to know after the baby is born.
Delivery Date	Enter the date of the delivery.
Weight	Enter the birth weight
Weight Units	Select the appropriate weight units.
APGAR Score	Enter the APGAR scores-up to three per neonate.
Delivery Type	Select the delivery type from the list. The Administrator can adjust this list.
Birth Type	Select the birth type from the list.
Fetal Outcome	Select the fetal outcome from the list.
Delivery Notes	Enter notes on the case.

Note:

When using the Neonate Information section, be aware of the following:

You can delete neonate information by right clicking the neonate and selecting the Delete option.
The system tracks changes to the neonate information in the audit log.

Event Death Details

The Event Death Details section enables you to enter information about the death of a patient.

Surrounding text describes eventdeathdetails.gif.

The following table lists and describes the fields in the Event Death Details section.

Field/Control Name	Description
Date of Death	Enter the date of death
Autopsy Done?	Select whether autopsy was done. Note: If Autopsy Done is set to No or Unknown, the Autopsy Results Available is shown as No.
Autopsy Results Available?	Select if autopsy results are available. Note: The Autopsy Results Available? field is enabled only if the Autopsy Done? field is marked as Yes. However, if Autopsy Results Available is changed to No and Autopsy Result rows exist, you will be asked to delete the rows first. Click Yes to delete the data.
Add	Click this button to add a Cause of Death and Autopsy Results row. Note: A user can add multiple records, up to 50 entries.
Delete	Enables you to delete a highlighted row.
Up/Down	Click Up to move the record up and click Down to move the record down. Note: Ordering reflected on the case form displays the same ordering as displayed in the E2B report repeatable tags.
Cause of Death	Describes the cause of death.
Description as Reported	Displays the description reported by the reporter.
Autopsy Result	Describes the autopsy results.
Encode	Encodes the event reported by the reporter.

Other Relevant History

The Other Relevant History section enables you to enter information that might be useful. The system lets you copy the Other Relevant History rows by selecting the row and clicking Copy. The following is an illustration of the Other Relevant History section.

Surrounding text describes reporterinfor.jpg.

Other Relevant History Fields and Field Descriptions

The following table lists and describes the fields in the Other Relevant History section.

Field/Control Name	Description
Copy	Enables you to copy a row. After you copy the row, the focus will be on the newly copied row.
Add	Enables you to add a row to the relevant history. After you add the row, the focus will be on the new row.
Delete	Enables you to delete a row from the relevant history.
Up	Enables you to move up a row in the relevant history.
Down	Enables you to move down a row in the relevant history.
Start Date	Enter the start date of the condition. You can enter a partial date if the actual date is not available. You can also choose not to enter a date. Note: If you click Add but do not enter a date, the Date column is removed. Once the date is entered and there is a test associated with the date, you cannot clear the date but can only modify it. To remove the date column, individually delete all the cells in that Date column.
Stop Date	Enter the stop date of the condition. You can enter a partial date if the actual date is not available. You can also choose not to enter a date. If you select Ongoing as Yes or Unknown, the system clears and disables the Stop date.
Age and Units	Age and Age units are enabled only for condition type with Patient Other Relevant Therapy being set.
Family History	Check this checkbox, if this relevant history is reported to be present in another family member. The Family History checkbox is enabled only for Condition types that are mapped to &rsquor;Medical History Episode' in the Condition Type codelist.
Condition Type/Verbatim/Indication/Reaction	Select a condition type from the list. The Administrator can adjust this list.
Substance Information	Displays the substance name, term ID, and strength unit of the Product separated by commas. If there are multiple records, they are displayed in subsequent rows.
Substance	Click Substance to enter the Substance Name, Term ID, and Strength Unit details.
Substance Name	Displays the Ingredient name.
Substance Term ID	Displays the Term ID of the substance selected.
Strength Unit	Displays the strength unit of the substance selected.
Name Part	Displays the name part and name part type information. If there are multiple records, they are displayed in subsequent rows. Click Name Part button to enter Product Name Part Type and Product Name Part details.
Name Part	Displays the Name of Product Name Part.
Name Part Type	Displays the type of Product Name Part such as Container Name, Device Name, Form Name, Invented Name, Scientific Name and so on.
Product Name Parts Information	Displays the Product Name Part information. Enabled only for condition type with Patient Other Relevant Therapy being set.
Product Identifier Type	Displays the type of Product Identifier such as MPID, PhPID, and so on. Enabled only for condition type with Patient Other Relevant Therapy being set.
Product Identifier Version	Displays the Date or Version of the Product Identifier. Enabled only for condition type with Patient Other Relevant Therapy being set.
Coded PT/Description of condition LLT/Indication PT/Reaction PT	Enter a term to describe the condition. You can either manually encode or auto-encode, if you have been so configured by the Administrator. In manual mode, type the description (for example, Fever). In Auto-encode mode, enter a partial description and press ENTER or TAB. The appropriate coding dialog appears. In either mode, you can click Encode and modify the encoding. If the condition type is historical drug, the encoding will be done with WHO drugs. Note: To view the complete MEDDRA hierarchy for the encoded term, click the encoding status icon.
Notes	Enter any notes that are relevant to the condition.
Encode	Click this button to encode the term. Encode is used in multiple contexts such as coding with MedDRA for reactions and indications, and coding for products using WHO drug browser. Note: To view the complete MedDRA hierarchy for the encoded term, click the encoding status icon.
Indication PT	Enter a term to describe the indication. Note: This field is visible on the case form only if the condition type selected in the List maintenance is Patient Other Relevant Therapy.
Ongoing	Indicates whether the condition is continuing. If it is set to Yes or Unknown, the Stop date is disabled.
Reaction PT	Enter a term to describe the reaction. Note: This field is visible on the case form only if the condition type selected in the List maintenance is Patient Other Relevant Therapy.

Lab Data

The Lab Data section provides data about lab test and test results. The maximum number of lab test data on the Case Form is 1500. The following is an illustration of the Lab Data section.

Surrounding text describes labdata.gif.

Lab Data Fields and Field Descriptions

The following table lists and describes the fields in the Lab Data section.

Field/Control Name Name	Description
Lab data Test as Reported
Test Name	Enter a lab test name, or select from the list.
Units	Select the unit of the lab test result.
Select Lab Test Group	Enables you to select one or more lab test groups.
Norm Low/Norm High	The Test Name list can retrieve details of the normal range for the test selected (if the Administrator has entered the normal range into the list). Otherwise, enter the values manually.
Date	Enter the date the test was carried out. Partial dates are allowed for in this field.
Result/Units	Enter the test result, including the appropriate units and select a term to describe the qualitative assessment of the results. The Administrator can modify the list of possible assessments.
Assessment	Select a qualitative assessment term to describe the lab test results.
More Info Available	Check this checkbox, if there is additional information is available for this Lab test in Additional Info tab.
Notes	Enter notes pertinent to this case.
Comments	Enter comments made by the reporter about the test result.

Using the Lab Data Section

When using the Lab Data section, be aware of the following:

A single, vertical scroll bar has been placed beneath the header and date information in the Lab Data section. This enables the date to be seen at all times.
- To keep all the rows together, all rows in the Lab Data Test as Reported " and Results/Units use this scroll bar.
- A maximum of three (3) rows is visible at all times.

You can perform several different actions in the Lab Data section as follows:

To enter a Lab Test Name

Click Add Test.
Enter a partial description of the lab test in the Lab Test Name dialog.
Click Search. Select the required lab test from the search results.

Selecting a Lab Test Group

The system enables you to select a lab test group from the dialog box.

When selecting a lab test group, be aware of the following:

When you click Select, the system populates the Lab Test Group with a list of lab tests that match the selected lab test group.
If lab test data is already on the Case form, the system appends the lab test group after the last lab test.

Arranging Entries in a Specific Order

Click the Order icons to arrange entries in a specific order.

Adding Additional Rows of Lab Test Data

Right-click on an empty cell as shown below. Click the Add option that gets displayed, to add more rows of lab test data.

Surrounding text describes labtestdata.jpg.

Deleting or Copying Rows in Lab Data

Right-click the row to be deleted or copied to an empty cell after a Test Date has been added, as shown below.

Surrounding text describes deleteltd.jpg.

The Copy and Delete options are displayed. Select the applicable option, as required.

Sorting the Entries

The Lab data will be displayed in chronological order by Date of the Test and alphabetically by the Test Name.

If there are partial dates entered, the date is displayed at the beginning of the month, and year for the date entered.

Viewing the Hierarchy of the Event Term

Click the icon to view the entire hierarchy of the Event Term.
Click outside the MedDRA hierarchy dialog to close this hierarchy listing.

Viewing Notes

Click the icon to view display the Notes in a Zoom dialog.

Arranging the Lab Test data

Click the arrow button to arrange the Lab Test to the right Lab Test. This is available only when the Lab Test has been entered for the same date.

Click the arrow button to arrange the Lab Test to the Left Lab Test. This is available only when the Lab Test has been entered for the same date.

Relevant Tests Section

This section enables you to enter additional information about any relevant tests, such as toxicology. The following is an illustration of this section.

Surrounding text describes relevanttests.gif.

The Parent Tab

Parent Information

The following is an illustration of the Parent tab.

Surrounding text describes parentinfo.gif.

Parent Tab Fields and Field Descriptions

The following table lists and describes the fields on the Parent tab.

Field/Control Name Name	Description
Title	Enter the title of the parent.
First Name	Enter the first name of the parent.
Middle Name	Enter the middle name of the parent.
Last Name	Enter the last name of the parent.
Parent Initials	Enter initials about the parent.
Date of Birth	Enter the parent's date of birth. You can enter a partial date if the actual date is unavailable.
Age	Calculates the parent's age, from the date of birth and earliest event onset date, if both full dates are available; otherwise, you can enter the age manually.
Units	Select the age units. Note: If both the date of birth and event onset date are available, age units field is automatically calculated. The Administrator can adjust this list.
Weight	Enter the parent's weight.
Weight Units	Select the appropriate weight unit.
Height	Enter the parent's height.
Height Units	Select the appropriate height unit.
Gender	Select the parent's gender. Note: If the parent is male, the system automatically disables the Pregnancy field. When the Gender is set to Female, the Pregnancy drop down is enabled and set to Unknown.
Date of LMP	Enter the date of the Last Menstrual Period, if applicable. A partial date can also be entered.
Parent Breastfeeding	Select the check box, if applicable.
Age at Vaccination	Parent age at vaccination is auto-calculated using Parent Date of Birth and Block 10 date (similar logic is used for Patient Age at Vaccination) only if both the dates are full dates.
Units (at Vaccination)	Displays the data from Age unit codelist for which 'Age unit' flag is marked as checked in Codelist Maintenance.
Ethnic Group	Enter the ethnic group of the parent.
Race	Select the parent's race. You can capture up to 5 Race using the Add and Delete buttons. Note: The system does not let you select the same Race more than once. If you try to select the same Race again, an error message appears.
Medical History	Captures information about the parent's medical history.

Other Relevant History

The Other Relevant History section for the Parent tab is similar to that of the Patient tab. However, the Family history, Age, and Units fields are unavailable.

Products Tab

The Products tab enables you to enter and view details about products and dosage regimens. The Products tab contains the name of the drug that has been entered within that tab. For Blinded Studies, the Blinded Product Name gets displayed in the tab.

When a user has no access to view unblinded information on the Case Form, the following fields are hidden:

Drug Code
Study Drug
Formulation
Concentration
Outside Therapeutic Range
Dose
Dose Description
Daily Dosage
Regimen Dosage
Patient Route of Administration
Parent Route of Administration
Package ID
Pack Units
Batch\Lot
Expiration Date
Total Dosage Units
Total Dose to Primary Event

General Usage Information

When using the Products tab, be aware of the following:

If the study has been unblinded and a study drug had been selected, the selected Study Drug Name is displayed. You cannot view unblinded information and the tab continues to show the Blinded Product Name.

You can enter details of more than one product and more than one dosage regimen for a company product for which multiple licenses exist (for example, drug and vaccine, or drug and device).

Depending on the type of license (drug, vaccine, or device), different views are available in the Products tab. If the selected item is not a company product or if a license for a company product does not exist, all three views are always available.

Time Measurement Fields

You can enter seconds in the following fields:

Argus > Case Actions > Open > (Select a Case) > Event tab > Event sub tab > {event description} sub tab > Event Information section (middle of screen)
- Onset From Last Dose field
- Duration field
- Onset Latency field
Argus > Case Actions > Open > (Select a Case) > Products tab > Product sub tab > {Product Name} sub-sub tab (drug) > Dosage Regimen section (lower 1/3 of screen)
- Duration of Regimen
Argus > Case Actions > Open > (Select a Case) > Products tab > Product sub tab > {Product Name} sub-sub tab (drug) > Product Details section (lower 1/3 of screen
- Duration of Administration
- Time between First Dose/Primary Event
- Time between First Dose/Primary Event
Any number following by the letter "s" defaults to "#sec."
The system interprets the seconds the user enters in the following formats where:

# is a number from 0 to 9

#s -- The system automatically changes the format to # sec.

# s -- The system automatically changes the format to # sec.

# sxx

where:

x is other letters -- The system automatically changes the format to # sec
The Temporal View and the Case Form printout display the seconds.
The E2B import and export case functions support seconds and M2 Validation for the defined fields.

Date of Mfr Field

You can enter a partial date in the Date of Mfr field. The MedWatch (Device) and EU Device Reports print the partial dates entered in the field.

The Products tab includes three tabs: Drug, Device, and Vaccine.

Surrounding text describes productstab.gif.

Drug Tab

The Products tab displays the Drug section by default as shown in the following illustration.

The Drug tab includes the following sections:

Product Information
Product Indication
Quality Control
Dosage Regimens
Product Details

The Product Information Section

This section enables you to enter information about the drug being used for the case. The following is an illustration of the Product Information section. Surrounding text describes productinfo.jpg.

Product Information - Fields and Field Descriptions

The following table lists and describes the fields and controls in the Product Information section.

Table 5-1

Field/Control Name	Description
Product Information
Product Name	The name of the product associated with the adverse event.
Suspect/ Concomitant/Treatment	Indicates whether the drug is suspect, concomitant or meant for treatment.
Generic Name	The generic name of the product
Product Identifier Type	The type of product Identifier selected.
Product Identifier	Displays the type of Product Identifier such as MPID, PhPID, and so on.
Version	Displays the Date or Version of the Product Identifier.
Company Drug Code	The unique value the company uses to identify the drug.
Obtain Drug Country	The name of the country where the drug was obtained.
Drug Code	The unique value that identifies the drug.
WHO Medicinal Product ID	The WHO Drug code used to identify the drug.
Formulation	The form in which the drug was administered (liquid, tablet, capsule, and so on.)
Drug Authorization Country	The country where the drug was authorized for use.
Manufacturer	The company that manufactured the drug.
Concentration	The amount of the drug that was administered.
Units	The drug unit (such as mg, tsp, and so on).
Interaction	Identifies the drug interaction, if any.
Contraindicated?	Identifies the contraindication, if any.
Drug Not Administered	Check this box, if the patient was not administered with the drug.
Substance Information
Substance Name	Displays the Ingredient's name.
Substance Term ID	Displays the Term ID of the substance selected.
Version	The Substance Term ID Version Date/Number of the substance used in the Product.
Strength	The Strength of the substance used in the Product.
Units	The drug unit (such as mg, tsp, and so on).
Product Name Parts Information
Name Part Type	The type of Product Name parts used in the product.
Name Part	The Product Name parts used in the product.

The Product Indication Section

The Product Indication section enables you to enter information about the indicator of the adverse event. It includes two fields: Reported Indication and Coded Indication.

Reported indication is the reported reaction and Coded Indication is the code for the reaction. The two values may be the same, but they may also be different.

The Quality Control Section

The Quality Control section enables you to enter quality control information.

Surrounding text describes qcinfodrug.gif.

Quality Control Fields and Controls

The following table lists and describes the fields in the Quality Control section.

Field/Control Name	Description
Quality Control Safety Date	Enter the Quality Control department reference number for the analysis.
Quality Control Sent Date	Enter the sent date.
Quality Control Cross Reference	Enter the Quality Control department reference number for the analysis.
Date Returned	Enter the date returned.
Global ID	Enter the global number.
Quantity	Enter the quantity.
# CID Number	Enter the Control Identification Number.
PCID Number	Enter the Product Control Identification Number.
Lot Number	Enter the lot number. If the Lot Number entered is incorrect, a Lot Number Lookup dialog is displayed, that allows you to enter select from the existing lot numbers.
Complaint Categories Date	Enter a date for complaint categories.
Complaint Categories Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Analysis Categories Date	Enter a date for analysis categories.
Analysis Categories Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Analysis Summary Date	Enter a date for an analysis summary.
Analysis Summary Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Quality Control Result Date	Enter the date the result of the analysis was received by the Quality Control department.
Quality Control Result	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Quality Control Comment	Enter any comment relating to the analysis.

The Dosage Regimens Section

The Dosage Regimens section enables you to enter information about the size and frequency of drug doses being given to a patient. The following is an illustration of the Dosage Regimens section.

Surrounding text describes dosageregimen.jpg.

Dosage Regimens Fields and Field Descriptions

The following lists and describes the fields in the Dosage Regimens section of the Drug tab.

Field/Control Name	Description
Start Date/Time	Enter the start date and time of the dosage. Entry of time information is optional, and you can enter partial dates.
Stop Date/Time	Enter the stop date and time of the dosage. Entry of time information is optional, and you can enter partial dates. Note: If no Stop Date is entered, Onset from Last Dose is calculated automatically from the Event Onset Date and the most recent Stop Date or the most recent Start Date.
Ongoing	Select this check box if the drug treatment is ongoing. The Stop Date, Duration of Regimen, and Last Dose fields are removed if this check box is selected.
Outside Therapeutic Range	Select this check box if the drug has not been used in accordance with the label or has been used for outside the Therapeutic Range. Consult your Administrator for further company-specific information on the use of this field.
Duration of Regimen	This value is calculated automatically, based on regimen start and stop dates (if full dates are entered for the start and stop dates). If the value is entered manually, the duration units (for example: minutes, hours, days, months, or years) must also be entered along with the actual duration. Note: The Administrator can set the duration to be inclusive or exclusive. In Inclusive mode, the starting day counts in the calculation of the duration; in Exclusive mode, it does not.
Dose Number	Enter the drug dose number.
Dose	Enter the dose received by the patient.
Dose Units	Select the dose unit. The Administrator can adjust this list.
Frequency	Select the frequency. The Administrator can adjust this list.
Dose Description	This value is automatically entered by using the values from Dose, Dose Units, and Frequency. If necessary, you can change this value. However, if Dose, Units, or Frequency information is changed, this value will be recalculated.
Daily Dosage	This value is calculated automatically depending on the dose and frequency. It can be manually overwritten. If either the dose or the frequency fields are blank, this field is not calculated automatically.
Daily Dosage Units	This value is derived automatically from the dose unit.
Regimen Dosage	This value is calculated automatically depending on the daily dose, duration, and frequency. This total can be overridden. If the daily dose is blank or the frequency fields are 0, this field is not calculated automatically.
Regimen Dosage Unit	This value is derived depending on the Daily Dose Units.
Route of Administration	Select the route of administration. The Administrator can adjust this list.
Parent Route of Administration	Select the route of administration for the parent. The Administrator can adjust this list.
Accidental Exposure	Select the type of Accidental Exposure from the list. A non-modifiable list of items is provided for this list.
Package ID	Enter the package ID.
Pack Units	Select the package presentation information of the product. The Administrator can adjust this list.
Batch/Lot #	Enter the batch and/or lot number(s).
Expiration Date	Enter the expiration date. Enter a partial date if the full date is not known.
(New) Tab	Click this tab to create a new dosage regimen entry.

The Product Details Section

Product Details Fields and Field Descriptions

The following is an illustration of the fields in the Product Details section of the Drug tab.

Surrounding text describes productdetails.jpg.

The following table lists and describes the fields in the Product Details section.

Field/Control Name	Description
First Dose	The earliest regimen start date, completed automatically.
Last Dose	The latest regimen stop date, completed automatically.
Duration of Administration	Calculated automatically if full dates are available for the first and last doses.
Total Dosage	Calculated automatically based on daily dose and duration.
Time Between First Dose/Primary Event	The time from the first dose to primary event onset.
Time between Last Dose/Primary Event	The time from the last dose to primary event onset.
Total Dose to Primary Event	The cumulative dose to time of the event.
Action Taken	Select the appropriate term. If you select Dose Increased or No change, the dechallenge and rechallenge fields are disabled. The Administrator can adjust this list.
Dechallenge Results	Indicates the drug stopped for the purpose of determining if it was the drug that caused the adverse event. Click the appropriate button.
Date	Enter the date the dechallenge was carried out
Gestation Period at Exposure	Gestation Period at Exposure is automatically calculated for all Products in the case by using the formula: Date of First Dose of the respective Product – LMP Date. It is calculated only if full dates available for both fields.
Taken Previously / Tolerated	Select the appropriate response from the list.
Rechallenge Results	Make the appropriate selection depending on whether the drug was taken again. If Pos or Neg or UNK is selected for the Rechallenge field, the Rechallenge Start Date/Time, Rechallenge Stop Date/Time, and the Rechallenge Outcome fields are enabled.
Start Date/Time	Enter the date and/or time when the rechallenge was started.
Stop Date/Time	Enter the date and/or time when the rechallenge was stopped.
Specialized Product Category	Select specialized FDA product categories such as combination products, compounded and repackaged products used in eVAERS reports.
Abuse	Select this checkbox if the patient abused the product (For example: Painkillers taken without pain).
Batch and lot tested and found within specifications	Check this checkbox if the batch and lot was found to be within specifications, after being tested.
Batch and lot tested and found not within specifications	Check this checkbox if the batch and lot was not found to be within specifications, after being tested.
Counterfeit	Check this checkbox if the patient took a counterfeit drug.
Drug taken by the father	Check this checkbox if the father of the patient had taken the drug.
Drug taken beyond expiry date	Check this checkbox if the drug was taken after its expiry date.
Medication Error	Check this checkbox if there was a medication error in administering the drug.
Misuse	Check this checkbox in case of possible misuse.
Occupational Exposure	Check this checkbox in case of occupational exposure.
Off Label Use	Check this checkbox in case of off-label use of the drug.
Overdose	Check this checkbox if the patient took an overdose of the product.
Tampering	Check this checkbox if the product appeared to have been tampered with before it was used.

Study Drug Information

You can enter a Study Drug for a Non-Configured Study entered in a case and mark a current product as a study drug.

To mark a product as a study drug

Right click on any suspect product in the case.
Select Make Study Drug to mark the current product as a study drug.

Be aware of the following:

The system disables the drug type to make the product a Concomitant or Treatment option.
Study Drug is a read-only field that contains the product name selected by the user.
For non-configured studies in the case, the system displays the following for all study drugs in the case:

Drug Not Administered.

The Device Tab

The Device tab enables you to enter information about devices being used for a particular case. It has the following subsections:

Product Information
Product Indication
Product Delivered by Device
Device Information

Product Information Section

The following is an illustration of the Product Information section of the Device tab.

Surrounding text describes devprodinfo.jpg.

Fields and Field Descriptions

The following table lists and describes the fields in the Product Information section.

Field/Control Name	Description
Product Information
Product Name	Enter the name of the product using the Select button or by entering a partial product name. Type a partial product name and press TAB. This displays the Product Selection dialog. If only one product is found, this information is entered without showing the dialog. If no match is found in the company product list, the WHO Drug Dictionary is searched for a possible match through the WHO Drug Dictionary Dialog. If a match is still not found, the text you initially typed in, is used as is. Note: If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown.
Select	Displays the product selection dialog. Select a product from the list of company products click Select. The relevant fields are added to the Case Form.
Encode	Click Encode to retrieve the code.
Suspect/ Concomitant/ Treatment	Make the appropriate selection for the product you are entering. The drug types indicate the involvement of the product with the adverse event(s) reported for the case. Suspect indicates that the product may have caused the adverse event(s). Concomitant indicates drugs that are taken with the suspect drug. Treatment is the drug taken to treat the adverse event.
Generic Name	Enter the generic name of the drug in a manner similar to the Product Name. If the study is blinded, the Generic Name is replaced with the Study Name of the product. Note: This name is entered automatically, depending on the chosen company product. Note: If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown.
Product Identifier Type	The type of product Identifier selected.
Product Identifier	Displays the type of Product Identifier such as MPID, PhPID, and so on.
Version	Displays the Date or Version of the Product Identifier.
Company Drug Code	Displays the licensed country for the selected company product.
Obtain Drug Country	Country the drug is licensed in.
Drug Code	Enter the WHO-DRUG code.
WHO Medicinal Product ID	Displays the Medicinal ID associated with the selected WHO drug. Note: This ID is populated only if a WHO-drug is selected.
Device Type	Indicates the type of device being used for this case.
Formulation	Select the formulation of the product. The Administrator can adjust this list. Note: This field is entered automatically depending on the product.
Drug Authorization Country	Enter the company drug code. Note: This name is entered automatically depending on the chosen company product.
Manufacturer	A different Manufacturer can be selected from the drop-down list and can still be kept as a company product.
Concentration	After a drug and formulation have been entered, select the concentration from the list, or enter the concentration. If this information is changed manually, the product is marked as a non-company product. Note: This field is entered automatically depending on the chosen product. The concentration cannot be modified for a Study drug.
Units	Select a concentration unit. The Administrator can adjust this list.
Interaction?	Indicates whether the case involves a drug interaction
Contraindicated?	Indicates whether the drug was administered contrary to its indication. Make the appropriate selection to indicate whether the drug was contraindicated in this case.
Drug Not Administered	Check this checkbox if no drug was administered.
Substance Information
Substance Name	Displays the Ingredient's name.
Substance Term ID	Displays the Term ID of the substance selected.
Version	Displays the Date or Version of the substance selected.
Strength	The strength of the substance used in the product.
Units	The drug unit (such as mg, tsp, and so on).
Product Name Parts Information
Name Part Type	The type of Product Name part used in the Product.
Name Part	The Product Name part used in the Product.
M/W Info	The MW Info dialog allows you to enter the following device information: Is this a single-use device that was reprocessed and reused on a patient?: Indicate whether the device was labeled for single use. If the question is not relevant to the device being reported (for example, an X-ray machine), leave the select box cleared. Reprocessor Name: Enter information for Address 1, Address 2, City, State, Country, Postal Code, Fax, and Email Address. Select if the device was an Adverse Event or a Product Problem. Type of Follow-up Report: Select the appropriate check boxes that most accurately describe the nature of the follow-up (supplemental) report as follows: Correction - Changes to previously submitted information. Additional information - Information concerning the event that was not provided in the initial report because it was not known/available when the report was originally submitted. Response to FDA request - Additional information requested by FDA concerning the device/event. Device Evaluation - Evaluation/analysis of device.
	Enter information for Address 1, Address 2, City, State, Country, Postal Code, Fax, and Email Address. Device Evaluated by Mfr: Select the Not returned to mfr. check box if an evaluation could not be made because the device was not returned to or made available to the manufacturer. Select Yes if an evaluation was made for the suspect medical device. You can attach a summary of the evaluation and select Yes, Summary Attached. If an evaluation of a returned suspect or related medical device was not conducted, check the No check box and attach an explanation or provide an appropriate code from the coding manual (Part II, Subpart A). Reason for Non-Evaluation: Enter the reason for the device not being evaluated by the manufacturer. Other Reason for Non-Evaluation: Enter other reasons for non-evaluation of the device.
	Patient Codes: Click Select to display the 'FDA Codes' dialog and to select the Patient codes. Device Codes: Click Select to display the 'FDA Codes' dialog and to select the Device codes. Evaluation Codes Information: Click Select to enter the applicable codes from the categories listed. Follow the instructions in the dialog to enter the evaluation codes. Conclusion codes must be entered even if the device was not evaluated. If reedial action initiated, check type: Select the applicable actions. If other, specify the type of action in the space provided (for further reference, see 21 U.S.C. 360h and 21 CFR part 803). Usage of Device: Make the appropriate selection to indicate whether the use of the suspect medical device was the initial use, reuse, or unknown. USC 360i(f) correction/removal reporting number: Enter the number that the FDA assigned to the corrective action. If the FDA has not yet assigned a number, the internal number assigned to the action by the company is used. Additional manufacturer narrative: Select the check box (if applicable) and enter any additional information, evaluation, or clarification of data presented in previous sections. Corrected Data: Select the check box if corrected data.
EU / CA Device	The EU/CA Device dialog allows you to enter the device information. Fields are marked by either an EU flag or a Canadian flag to indicate which entity is mapped to the field. The following list describes each field in detail: Accessories / Associated Devices: Enter associated devices and/or accessories involved in the incident. Does the Incident represent a serious public threat?: Select the appropriate incidence type. Number of similar incidents: Enter the number of similar incidents. Software Version: Enter relevant software version. Identification of Notified Body involved in Conformity Assessment: Enter identification number of the Notified Body involved in the conformity assessment procedure (if any) and the date(s) of the attestation(s).
	User facility reference number: Enter the user facility reference number. NCA Reference Number: Enter the NCA reference number. Number of Patients Involved: Enter the number of patients involved in the incident. Number of Devices Involved: Enter the number of devices involved. Identify to what other NCAs this report was also sent: Enter the other NCAs to which this report was sent. Remedial Action by HC Facility: Enter the remedial action taken by the Health care facility.
	Usage of Medical Device: Select the relevant option. Update to Initial Report (Follow-up Report): Select this check box if the Follow-up report must be updated to an Initial report. Final Report: Select this check box if this is the final report. Was the device labeled sterile?: Select the appropriate choice. Importer Reported to Manufacturer: Select Yes or No. During Investigational Testing: Select Yes or No. Importer Submitted on behalf of Manufacturer: Select Yes or No. Special Access Program Device: Select Yes or No. Number of Years since Manufacturing Date: enter the number of years since the manufacturing date. Radiation Emitting Device: Select Yes or No.
	Availability of Device: Select whether the device was Destroyed, Returned to Manufacturer/Importer, or Neither. Explanation: Enter the explanation in the text box provided. Name of Health Care Facility: Enter the name of the health care facility.
	Reporting firm is aware of other similar incidents having an impact on the current report: Select the appropriate choice. If yes, to which countries (EEA countries): Enter appropriate countries. Device distributed within the following EEA Countries: Enter appropriate countries. Current location of device: Enter the present location of the device that was involved in the incident. Where was the device purchased: Enter the establishment where the device was purchased. Address: Enter the address of the location where the device was purchased. Expected date of follow-up report: Enter the expected date of follow-up report.
	Initial Corrective Action: Enter corrective action for the Initial report. Initial Project Timing: Enter projected timing for the Initial report. Final Corrective Action: Enter corrective action for the Final report. Final Project Timing: Enter projected timing for the Final report. Investigation Result: Enter the results of investigation from the follow-up. Further Investigation: Enter the details of further investigation from the follow-up. Comments: Enter any manufacturer comments.

Searching for Products

You can perform two types of searches in the section:

Product Browser Search
WHO Drug Coding Search

Product Browser Search

To search for a product

Click Select in the Products tab.
The Product Browser dialog is displayed.
Click Select to start searching.
When the system opens the Product Browser dialog box, Click the entities displayed in the dialog.

The hierarchy above and below the entity being searched is also displayed. For example, if Product Name is searched, it displays the Product Name as well as the Family Name and Trade Name.
Search for Products based on the following criteria:
- Ingredient
- Family
- Product Name
- Trade Name - Searches the License Trade Name
Click the Full Search check box to select all these criteria when searching.
Click Select.
The results based on the search criteria are displayed and the user can select the Product.
Click Clear to remove the entered search criteria.

WHO Drug Browser Search

Be aware of the following when using the WHO Drug Browser search function:

The system enables you to perform a full search from the WHO Drug browser when you select the Full Search option.
- By default, the system performs a like search (e.g., CUREALL%)
- You can use the percent (%) sign to perform wildcard searches
- If you click Full Search, the system performs a full search (e.g., %CUREALL%)
The system also enables you to search for drug formulation and country. However, this is available only if you select the WHO Drug C format. Otherwise, the option is disabled.
When you click Clear, the system clears the search criteria you entered.
After the system performs the search, you can sort the results on all the fields.

To perform a WHO Drug Browser Search

Select the Encode button to open the WHO Drug Coding dialog.
You can use both the WHO Drug B Format as well as the WHO Drug C Format using the same browser.

Select either the WHO Drug B format or the WHO Drug C format from the Case Form Configuration dialog where the Dictionaries are chosen for encoding.
Enter your search criteria in these fields and click Search to display the product attributes that match the given search criteria:
- Trade Name - the trade name of the product
- Formulation / Strength - the Formulation / Strength (sequence 3 and sequence 4) of the product.
- Country - The Sales Country Code of the Product as defined in the WHO Dictionary
- Generic - Whether Generic - Yes or No.
  
  The following criteria are not available for display or searching in the WHO Drug B Format:
  - Formulation
  - Country
  - Strength
  - Generic
  - Medicinal Product ID
  - Product Type
Click Select to copy the selected drug to the Product tab.
Click Cancel to close the selection dialog without making any updates to the Product tab.

The WHO Drug Coding Dialog has the following fields:

Field	Description
Product Type	Select the type of product from the drop-down list. Note: All is displayed as the Product Type by default.
ATC Code	Enter the ATC Code up to a maximum of 10 characters.
Drug Code / Medicinal Prod ID	Searches on either criterion as per the radio button selected for the search. By default, the Drug Code option is selected.
Trade Name / Ingredient	Searches on either criterion as per the radio button selected for the search. By default, the Trade Name option is selected.
Formulation	Enables you to search based on the drug formulation.
Country	Enables you to search for a drug based on the country where the drug was sold.

Entering Quality Control Information

You can enter quality control information by clicking the Quality Control button and entering the appropriate information in the Quality Control dialog box.

About the Quality Control Dialog Box

The following is an illustration of the Quality Control dialog box.

Surrounding text describes qualitycontrol.gif.

The following table lists and describes the fields in the Quality Control dialog box.

Field	Description
Quality Control Safety Date	Enter the Quality Control department reference number for the analysis.
Quality Control Sent Date	Enter the sent date.
Quality Control Cross Reference	Enter the Quality Control department reference number for the analysis.
Date Returned	Enter the date returned.
Global ID	Enter the global number.
Quantity	Enter the quantity.
# CID Number	Enter the Control Identification Number.
PCID Number	Enter the Product Control Identification Number.
Lot Number	Enter the lot number. If the Lot Number entered is incorrect, a Lot Number Lookup dialog is displayed, that allows you to enter select from the existing lot numbers.
Complaint Categories Date	Enter a date for complaint categories.
Complaint Categories Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Analysis Categories Date	Enter a date for analysis categories.
Analysis Categories Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Analysis Summary Date	Enter a date for an analysis summary.
Analysis Summary Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Quality Control Result Date	Enter the date the result of the analysis was received by the Quality Control department.
Quality Control Result	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Quality Control Comment	Enter any comment relating to the analysis.

Product Indication Section

The following is an illustration of the Product Indication section of the Device tab.

Surrounding text describes prodindication.jpg.

Product Indication Fields and Field Descriptions

The following table lists and describes the fields in the Product Indication section.

Field/Control Name	Description
Reported Indication	By default, the value of this field is populated with the Product Indication from the Product Configuration, if set up by the user. If not, you can enter a term into the Reported Indication field. Note: Argus Safety automatically encodes this information. You can also click Encode to open the coding dictionary dialog.
Coded Indication	This field is populated with the encoded term when the user enters data in the reported indication field and tabs out.
Encode (Indication)	Opens the MedDRA Browser with the term already populated from the Coded Indication field. Note: To view the complete MEDDRA hierarchy for the encoded term, click the Encoding Status icon.
Add	Adds a new Indication row. Note: Only two indications are visible at a time
Delete	Click this button to delete the selected Indication row.

Product Delivered by Device Section

The following is an illustration of the Product Delivered by Device section

Surrounding text describes prodeliverdevice.gif.

Product Delivered by Device Fields and Field Descriptions

The following table lists and describes the fields in the Product Delivered by Device section.

Field/Control Name	Description
Type of Drug	Select the type of drug from the drop-down list.
Other Mfg Product	Displays the Other Manufacturing Product.
Add	Adds another row.
Delete	Deletes the highlighted row.

Device Component Information

This section enables you to enter information about the device component being used. The following is an illustration of the section.

Surrounding text describes devicecompinfo.gif.

Field/Control Name	Description
Component Name	The device component name used in the product.
Component Term ID	The device component term ID of the device component used in the product.
Version	The Date or Version of the device component term ID of the device component used in the product.
Batch Lot #	The batch lot number of the device component name used in the product.
Add	Adds another row.
Delete	Deletes the highlighted row.

Device Information Section

This section enables you to enter information about the device being used. The following is an illustration of the section.

Surrounding text describes deviceinfo.jpg.

Device Information Fields and Field Descriptions

When using the Device Information section, be aware of the following:

You can enter up to 10,000 characters in the Additional Manufacturer Narrative field.
The device evaluation codes have been updated to reflect FDA standards. Go to the following link for more information: http://www.fda.gov/cdrh/mdr/373_appdxb.html.
The evaluation method is available is the following site: http://www.fda.gov/cdrh/mdr/373.html.
The evaluation results are available at the following site: http://www.fda.gov/cdrh/mdr/373_appdxd.html.

The following table lists and describes the fields in the Device Information Section

Field/Control Name	Description
Product Information
Lot #	Enter the lot number of the device.
Expiration Date	Enter the expiration date. Enter a partial date or no date if the full date is not available.
Date of Mfr	Enter the month and year of manufacture of the suspect medical device.
Device Age	Enter the age of the device.
Units	Enter the unit.
Model #	Enter the model number of the device.
Serial #	Enter the serial number of the device.
Catalog #	Under Catalog#, enter the exact catalog number as it appears in the manufacturer's catalog, device labeling, or accompanying packaging.
Unique Identifier (UDI) #	Under Unique Identifier (UDI) #, enter any other applicable identification number (for example: component number, product number, part number, bar-coded product ID).
Date Implanted	If the device is implantable, enter the date of the implant. Enter a partial date if the full date is not available.
Date Explanted	If the device is implantable, enter the date of the explant, if any. Enter a partial date if the full date is not available.
Improper Use/Storage	Indicate if the device was improperly used or stored.
Operator of Device	Select the type of person operating or using the suspect medical device on the patient at the time of the event such as Health Care Professional, Patient, Paramedic and so on.
If other	If the operator of the device is other, enter the operator of the device.
Trained User	Indicate if the operator of the devices was trained to use the device.
Duration of implantation	The duration of implantation.
Malfunction	Indicate if the devices malfunctioned.
Malfunction Type	Make the appropriate selection to indicate the type of reportable event. For an event associated with a malfunction, the FDA refers users to applicable sections in 21 CFR Part 803 reporting guidelines.
Manufacturer/Importer Awareness Date	Enter the date when the manufacturer became aware of the event
Device Available for Evaluation	Indicate whether the device is available for evaluation. Also, indicate whether the device was returned to the manufacturer and if so, the date of the return.
Returned to manufacturer on	Enter the Device Return Date.
Preliminary Comments	Enter or select preliminary comments.
Malfunction Information	-
Reported Malfunction	Enter the malfunction as entered by the reporter.
Determined Malfunction	Enter the malfunction as determined by the company.
Listedness	Enter the listedness of malfunction in respect of the device.
Reportable	Select the reportability of the malfunction.

EU/CA Device Dialog Fields and Field Descriptions

The EU/CADevice Fields dialog includes the following fields:

NCA Reference Number
Identify to what other NCA's this report was also sent
Number of Patients Involved
Number of Devices Involved
User facility reference number
Remedial Action by HC Facility
Usage of Medical Device
Other
Update to Initial Report (Follow-up Report)
Final Report

The following table provides attribute information for the device fields

Field/Control Name Name	Field Length	Field Type
NCA Reference Number	100 characters	Alphanumeric
Identify to what other NCA's this report was also sent	2000 characters	Alphanumeric
Number of Patients Involved	3 characters	Numeric
Number of Devices	3 characters	Numeric
User facility reference number	20 characters	Alphanumeric
Remedial Action by HC Facility	1000 characters	Alphanumeric
Usage of Medical Device	N/A	Check box
Other	15 characters	Alphanumeric
Update to Initial Report (Follow-up Report)	N/A	Check box
Final Report	N/A	Check box

When you select the EU/CA Device option, the system prints the fields on the Case form. The system tracks the fields and any updates in the audit log.

Vaccine Tab

The Vaccine section of the Products tab enables you to enter information about a vaccine. The Vaccine tab includes the following sections:

Product Information Section
Product Indication Section
Quality Control Section
Vaccine Information Section
Product Details Section
Vaccine Administration
Prior Adverse Events
Vaccine History Section

Product Information Section

Fields and Field Descriptions

The following table lists and describes the fields in the Product Information section.

Field/Control Name	Description
Product Name	Enter the name of the product using the Select button or by entering a partial product name. Type a partial product name and press TAB. This displays the Product Selection dialog. If only one product is found, this information is entered without showing the dialog. If no match is found in the company product list, the WHO Drug Dictionary is searched for a possible match through the WHO Drug Dictionary Dialog. If a match is still not found, the text you initially typed in, is used as is. Note: If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown.
Select	Displays the product selection dialog. Select a product from the list of company products click Select. The relevant fields are added to the Case Form.
Encode	Click Encode to retrieve the code.
Include in VAERS Block	Select the VAERS Form block that this vaccine needs to be printed in.
Suspect/Concomitant/Treatment	Make the appropriate selection for the product you are entering. The drug types indicate the involvement of the product with the adverse event(s) reported for the case. Suspect indicates that the product may have caused the adverse event(s). Concomitant indicates drugs that are taken with the suspect drug. Treatment is the drug taken to treat the adverse event.
Generic Name	Enter the generic name of the drug in a manner similar to the Product Name. If the study is blinded, the Generic Name is replaced with the Study Name of the product. Note: This name is entered automatically depending on the chosen company product.
Product Identifier Type	The type of product Identifier selected.
Product Identifier	Displays the type of Product Identifier such as MPID, PhPID, and so on.
Version	Displays the Date or Version of the Product Identifier.
Company Drug Code	Enter the company drug code. Note: This name is entered automatically depending on the chosen company product.
Obtain Drug Country	Enter the country where the drug was purchased.
Drug Code	Enter the WHO-DRUG code.
WHO Medicinal Product ID	Displays the Medicinal ID associated with the selected WHO drug. Note: This ID is populated only if a WHO-drug is selected.
Formulation	Select the formulation of the product. The Administrator can adjust this list. Note: This field is entered automatically depending on the product.
Drug Authorization Country	Displays the licensed country for the selected company product.
Manufacturer	A different Manufacturer can be selected from the drop-down list and can still be kept as a company product.
Concentration	After a drug and formulation have been entered, select the concentration from the list, or enter the concentration. If this information is changed manually, the product is marked as a non-company product. Note: This field is entered automatically depending on the chosen product. The concentration cannot be modified for a Study drug.
Units	Select a concentration unit. The Administrator can adjust this list.
Interaction?	Indicates whether the case involves a drug interaction
Contraindicated?	Indicates whether the drug was administered contrary to its indication. Make the appropriate selection to indicate whether the drug was contraindicated in this case.
# of Siblings	Enter the number of siblings for patients who are children under the age of five.
Birth Weight	For patients who are children under the age of five, enter the birth weight. For example: 3260g, 3.26kg, or 7lb 4oz. If a number without units is entered, the following units are assumed: < 32 - Pounds 32-200 - Ounces >200 - Grams
Birth Weight Units	Select the appropriate weight units.

Searching for Products

You can perform two types of searches in the section:

Product Browser Search
WHO Drug Coding Search

To perform a search in the Product Browser dialog box

Click Select in the Products tab.
The Product Browser dialog is displayed.
Click Select to start searching.
When the system opens the Product Browser dialog box, Click the entities displayed in the dialog.

The hierarchy above and below the entity being searched is also displayed. For example, if Product Name is searched, it displays the Product Name as well as the Family Name and Trade Name.
Search for Products based on the following criteria:
- Ingredient
- Family
- Product Name
- Trade Name - Searches the License Trade Name
Click the Full Search check box to select all these criteria when searching.
Click Select.
The results based on the search criteria are displayed and the user can select the Product.
Click Clear to remove the entered search criteria.

WHO Drug Browser Search

Be aware of the following when using the WHO Drug Browser search function:

The system enables you to perform a full search from the WHO Drug browser when you select the Full Search option.
- By default, the system performs a like search (e.g., CUREALL%)
- You can use the percent (%) sign to perform wildcard searches
- If you click Full Search, the system performs a full search (e.g., %CUREALL%)

The system also enables you to search for drug formulation and country. However, this is available only if you select the WHO Drug C format. Otherwise, the option is disabled.
When you click Clear, the system clears the search criteria you entered.
After the system performs the search, you can sort the results on all the fields.

To perform a WHO Drug Browser Search

Select the Encode button to open the WHO Drug Coding dialog.

You can use both the WHO Drug B Format as well as the WHO Drug C Format using the same browser.

Select either the WHO Drug B format or the WHO Drug C format from the Case Form Configuration dialog where the Dictionaries are chosen for encoding.

The WHO Drug Coding Dialog has the following fields:

Field/Control Name	Description
Product Type	Select the type of product from the drop-down list. Note: All is displayed as the Product Type by default.
ATC Code	Enter the ATC Code up to a maximum of 10 characters.
Drug Code / Medicinal Prod ID	Searches on either criterion as per the radio button selected for the search. By default, the Drug Code option is selected.
Trade Name / Ingredient	Searches on either criterion as per the radio button selected for the search. By default, the Trade Name option is selected.
Formulation	Enables you to search based on the drug formulation.
Country	Enables you to search for a drug based on the country where the drug was sold.

Enter your search criteria in these fields and click Search to display the product attributes that match the given search criteria:
- Trade Name -- the trade name of the product
- Formulation / Strength -- the Formulation / Strength (sequence 3 and sequence 4) of the product.
- Country -- The Sales Country Code of the Product as defined in the WHO Dictionary
- Generic - Whether Generic - Yes or No.
  
  The following criteria are not available for display or searching in the WHO Drug B Format:
  - Formulation
  - Country
  - Strength
  - Generic
  - Medicinal Product ID
  - Product Type
Click Select to copy the selected drug to the Product tab.
Click Cancel to close the selection dialog without making any updates to the Product tab.

Product Indication Section

The following is an illustration of the fields in the Product Indication section of the Vaccine tab.

Surrounding text describes prodindication.jpg.

Product Indication Fields and Field Descriptions

The following table lists and describes the fields in the Product Indication section.

Field/Control Name	Description
Product Indication Section
Reported Indication	By default, the value of this field is populated with the Product Indication from the Product Configuration, if set up by the user. If not, you can enter a term into the Reported Indication field. Note: Argus Safety automatically encodes this information. You can also click Encode to open the coding dictionary dialog.
Coded Indication	This field is populated with the encoded term when the user enters data in the reported indication field and tabs out.
Encode (Indication)	Opens the MedDRA Browser with the term already populated from the Coded Indication field. Note: To view the complete MEDDRA hierarchy for the encoded term, click the Encoding Status icon
Add	Adds a new Indication row. Note: Only two indications are visible at a time
Delete	Click this button to delete the selected Indication row.
Up	Allows the user to move an indication up.
Down	Allows the user to move an indication down.

Quality Control Section

You can enter quality control information and enter the appropriate information in the Quality Control section. The following is an illustration of the section.

Surrounding text describes qualitycontrol.gif.

The following table lists and describes the fields in the Quality Control window.

Field/Control Name	Description
Quality Control Safety Date	Enter the Quality Control department reference number for the analysis.
Quality Control Sent Date	Enter the sent date.
Quality Control Cross Reference	Enter the Quality Control department reference number for the analysis.
Date Returned	Enter the date returned.
Global ID	Enter the global number.
Quantity	Enter the quantity.
# CID Number	Enter the Control Identification Number.
PCID Number	Enter the Product Control Identification Number.
Lot Number	Enter the lot number. If the Lot Number entered is incorrect, a Lot Number Lookup dialog is displayed, that allows you to enter select from the existing lot numbers.
Complaint Categories Date	Enter a date for complaint categories.
Complaint Categories Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Analysis Categories Date	Enter a date for analysis categories.
Analysis Categories Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Analysis Summary Date	Enter a date for an analysis summary.
Analysis Summary Text	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Quality Control Result Date	Enter the date the result of the analysis was received by the Quality Control department.
Quality Control Result	Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.
Quality Control Comment	Enter any comment relating to the analysis.

Vaccine Information Section

You can enter vaccine information and enter the appropriate information in the Vaccine Information section. The following is an illustration of the section.

Surrounding text describes vaccineh.gif.

Vaccine Information Fields and Field Descriptions

The following table lists and describes the fields in the Vaccine Information section.

Field/Control Name	Description
Start Date/Time	Enter the vaccination date. Enter a partial date if the full date is not available.
Dose Number	Enter the vaccine dose number.
Dose	Enter the vaccine dose.
Units	Select the dose unit. The Administrator can adjust this list.
Dose Description	Enter a description of the vaccine dose.
Patient Route of Administration	Enter the route of administration or a short code for the route of administration. The system automatically decodes your entry. The Administrator can adjust this list.
Parent Route of Administration	Enter the route of administration or a short code for the route of administration. The system automatically decodes your entry. The Administrator can adjust this list.
Package ID	Enter the package ID.
Batch / Lot #	Enter the batch and/or lot number(s).
Expiration Date	Enter the expiration date. Enter a partial date or no date if the full date is not available.
Block 10	If this box is checked, the Start Date in this Dosage record and the time from the leftmost CDD vaccine will be printed in the VAERS Form Block 10 as Date of Vaccination.
Block 14	If this box is checked, this Dosage record will be printed in the VAERS Form Block 14.
Anatomical Location	Select the anatomical location of the vaccination. The Administrator can adjust this list.

Product Details Section

This section is the same for the Product Details section under all the tabs - in the Drugs tab, Device tab, and the Vaccine tab.

See the The Product Details Section for details about this section.

Vaccine Administration

The following is an illustration of the Vaccine Administration form.

Surrounding text describes vaccineadmin.jpg.

To enter vaccine administration information:

Enter the relevant vaccination information items in the form.

The following table lists and describes the fields in the Vaccine Administration form.

Field/Control Name	Description
Best Doctor / Health Care Professional Information
Title	Enter the health care professional's name title, if applicable.
First Name	Enter the first name of the health care professional.
Middle Name	Enter the middle name of the health care professional.
Last Name	Enter the last name of the health care professional.
Suffix	Enter the health care professional's name suffix, if applicable.
Phone	Enter the telephone number of the health care professional.
Email Address	Enter the email address of the health care professional.
Person Completing Form Relationship to Patient	Select an appropriate item from the list.
For VAERS Form-1 Use Only
Administered By	Enter the name of the person who administered the vaccine.
Resp. Physician	Enter the name of the physician responsible for the patient.
County	Enter the county where the patient was vaccinated.
State	Enter the state where the patient was vaccinated.
CDC/FDA VAERS #	Enter the verification number.
Purchased With	Select the most appropriate item from the list to describe how the vaccine was purchased.
Illness at time of Vaccination	Enter the illness, if known.
Reported Previously	Select an appropriate item from the list.
Required ER Visit	Select this check box if the event required a visit to the emergency room or doctor.
Vaccine Facility Information
Facility Name	Enter the name of the facility where the vaccine was administered.
Address 1	Enter line 1 of the address of the facility.
Address 2	Enter line 2 of the address of the facility.
Country	Enter the country of the facility where the responsible physician works.
Postal Code	Enter the postal code of the facility.
City	Enter the city of the facility where the responsible physician works.
Phone	Enter the telephone number of the facility.
State	Enter the state of the facility.
Fax	Enter the fax number of the facility.
Facility Type	Enter the facility type where the patient was vaccinated.
Facility Military Flag	Select Yes or No indicate whether or not the vaccination facility was a Military facility.

Prior Adverse Events

The following is an illustration of the Vaccine Prior Adverse Events form.

Surrounding text describes encode.jpg.

To enter prior adverse events information

Enter the relevant vaccination information items in the form.
Click OK to save the entered prior vaccination adverse event information.

The following table lists and describes the fields in the Vaccine Prior Adverse Events form.

Field/Control Name	Description
Patient	Select whether the details refer to the patient or to a sibling.
Vaccine	Enter the name of the vaccine.
Dose #	Enter the dose number of the vaccine.
Age	Enter the patient's age at onset of the event.
Age Units	Select the appropriate age unit from the list.
Adverse Events	Enter a term that describes the adverse event. Click the Encode button to encode the term.

Vaccine History Section

The following is an illustration of the Vaccine History section of the screen.

Surrounding text describes vch.jpg.

Vaccine History Fields and Field Descriptions

The following table lists and describes the fields in the Vaccine History section.

Field/Control Name	Description
Date	Enter the date of vaccination. Enter a partial date if the full date is not available.
Route of Admin	Enter the route of administration or a short code for the route of administration. The system automatically decodes your entry. The Administrator can adjust this list.
Vaccine	Enter the name of the vaccine.
Generic Name	Enter the generic name of the vaccine.
Anatomical Location	Select the anatomical location of the vaccination. The Administrator can adjust this list.
Dose #	Enter the vaccine dose number.
Manufacturer	Enter the vaccine manufacturer or select a manufacturer. The Administrator can adjust this list.
Dose	Enter the vaccine dose.
Units	Select the dose unit. The Administrator can adjust this list.
Batch & Lot #	Enter the batch and/or lot number(s).
Block 14	If this box is checked, this Vaccine History will be printed in the VAERS Form Block 14.
Add	Adds a new Indication row. Note: Only two indications are visible at a time.
Delete	Click this button to delete the selected Indication row.

Events Tab

The Events tab enables you to enter or view details for adverse events associated with a case. The following is an illustration of the Events tab.

Surrounding text describes eventtab.gif.

General Usage Information

When using the Events tab, be aware of the following:

- You can change the listedness for a drug at the individual level.
- This limitation also applies to the Medical Review and Local Labeling dialogs.
The field labels for the Event Assessment tab are updated and configured on the Argus Console.
When you modify the Event outcome on the Events Tab, and the event outcome and case outcome do not match, the system displays the following message:

Case Outcome may no longer match events.
If the Death Seriousness criteria on the Event tab are unchecked, the event outcome reverts to empty and is not set to fatal.
On the Death Details screen, the Autopsy Results field defaults to blank instead of No. If the value is incorrectly set, the system sets it to null during the upgrade.
On the Event Assessment tab, the system displays the Notes icon beside the event term if the preferred term has associated notes on the datasheet.
If the datasheet does not have notes for the preferred term, the system does not display the Notes icon.
This is also true for the Medical Summary and the Local Labeling dialog
When you click the Notes icon, the system displays the notes in read-only mode.
If Allow User to Add Non-Current MedDRA Terms for is configured to Case where Country of Incidence (COI) is other than Japan, the existing application behavior is maintained as:

a. For COI other than Japan: The user can choose a MedDRA LLT term for which LLT (J) is non-current, that is, based on English currency.

b. For COI as Japan: Existing application behavior is retained, and if an E or J user tries to add a LLT with Non-current LLT(J), the application displays an error message.

c. The application indicates the Non-current LLT (J) term with icon indicator on the English side of the Case Form similar to the way it indicates Non-current LLT (J) on the Japan side of the Case Form for both English and Japan users.

If the Allow User to Add Non-Current MedDRA Terms for is configured to Case irrespective of Country of Incidence, the existing application behavior is modified as:

a. Irrespective of COI of the case, both E and J users can add a LLT to the case for which LLT (J) is non-current, that is, based on English currency.

b. Also, there is an indicator on both sides (English and J) to indicate the Non-current LLT (J) term similar to the way it indicates a Non-current LLT (J) on the Japan side of the Case form for both English and J users.
The MedDRA LLT term selection behavior across the Case Form (not limited to the list mentioned below) is governed based on the profile switch value configured in the Allow User to Add Non-Current MedDRA Terms for and On change of LLT Term Sync English and Japan LLTs, irrespective of the currency.
- Book-in -> Description as Reported
- Case Form -> Patient -> Lab Data -> Test Name
- Case Form -> Patient -> Other Relevant History -> Verbatim/Indication/Reaction
- Case Form -> Patient Tab -> Patient Sub Tab -> Death Details -> Cause of Death To be Coded
- Case Form -> Patient Tab -> Patient Sub Tab -> Death Details -> Autopsy Results To be Coded
- Case Form -> Parent -> Other Relevant History -> Verbatim/Indication/Reaction
- Case Form -> Products -> Product Indication -> Reported Indication
- Case Form -> Product-> Vaccine -> Prior Adverse Event -> Adverse Events
- Case Form -> Event -> Description to be Coded
- Case Form -> Event -> Event Death Details -> Description as Reported
- Case Form -> Analysis Tab -> Company Diagnosis Syndrome
- Coding Review -> Prior Adverse Event -> Adverse Events
- Coding Review -> Event Information -> Description to be Coded
The system populates the To be coded value on the MedDRA popup dialog box when you click the green checkbox for the MedDRA hierarchy. This applies to the following area where the MedDRA dialog box appears.
- Patient Tab: Other Relevant History: Description
- Patient Tab: Other Relevant History: Reaction
- Patient Tab: Other Relevant History: Indication
- Patient Tab: lab Tests
- Product Tab: Product Indications
- Event Tab: Event Coding
- Analysis Tab: Company Diagnosis Syndrome
- Console: Business Configuration: Products: Datasheets
- Console Business Configuration: Products: Product Indications
- Console: Codelists: Lab Tests
- Console: Codelists: Always Serious Term List
The Event to Exclude from Report Field enables you to identify information not to include in a PMDA expedited report.
- The default for this check box is unchecked.
- When this check box is checked, you are required to enter a justification for this action in the Reason to Exclude from Report dialog box.
- After you enter the justification, the system places a symbol to the right of the field.
- You must have at least one event in a report. If you try to exclude all events from the report, the system presents the following message: "All the events are excluded from reports. If you want to report, at least one event is necessary. Proceed?"
- The system does not retrieve events that are excluded from a report as part of CSPSR (Clinical Study Periodic Safety Report) unless it has been configured to include them in such a report.

The following is an illustration of the MedDRA dialog box.

Surrounding text describes eventst.jpg.

When you click the Recalculate button, the system does not recalculate listedness where the Event Assessment Listedness already has a case justification (generated automatically or manually overwritten).

Field Properties for Help Text/Default Labels

The following table describes the field properties for the Help Text/Default Labels.

Default Field Label	Default Help Text
Onset from First Dose	This date is defined as the earliest regimen start date to Onset and is completed automatically. The Date calculation is based on the Case Form Calculation for Inclusive or Exclusive
Onset from Last Dose	This date is defined as the latest regimen stop date to Onset and is completed automatically. The Date calculation is based on the Case Form Calculation for Inclusive or Exclusive.
Total Dose to Event	The system calculates this value based on daily dose and duration.
Units	The system provides this value based on the dosage units entered.
Action Taken	Select the appropriate term from the drop-down list (e.g., Dose Increased, Withdrawn, etc.). The Administrator may adjust the values in this list.
Other	The value can only be entered when the Action Taken is "Other."
Dechallenge Results	Select the appropriate option.
Rechallenge Results	Select the appropriate option.
Event occurred as consequence of	Select the appropriate option.
Term	Select the appropriate option.
Most Important Diagnosis?	Select the appropriate option.
Event more specific/severe than PT?	Select the appropriate option.

Field Calculations

The following table describes the calculations the system uses for each field.

Field	Calculation
Total Dosage	The sum of all Total Regimen Dosages.
First Dose to Onset	The system calculates this value based on the first dose stop date and the event onset date, if present. If any regimen start date is null, the system sets the First Dose to Onset is to null. The system does not automatically use partial date entries for the Regimen Start and Stop Date/Time fields to calculate First Dose to Onset. The user can overwrite this field.
Last Dose to Onset	The system calculates this value based on the last dose stop date and the even onset date, if present. If the regimen start date is null, the system sets the Last Dose to Onset is to null. The system does not automatically use partial date entries for regimen Start and Stop Date/Time fields to calculate the Last Dose to Onset. The user can overwrite this field.

Event

The Event information tab enables you to encode adverse events, record the criteria for the seriousness of each event, and display the results of automated assessments to determine whether events are listed in data sheets. It also lists the licenses for the data sheets. The Event information tab includes the following sections:

Event Information
Event Coding
Seriousness Criteria
Nature of Event
Details

Surrounding text describes eventst1.jpg.

Event Information Section

The Event Information section enables you to enter information about the event information including diagnosis, patient history, intensity, and so forth.

Event Information Fields and Field Descriptions

The following table lists and describes the fields in the Event Information section.

Field/Control Name	Description
Relationships	Click the Relationships button to view the Diagnosis-Event Relationships dialog. This allows you to group symptoms and signs with diagnoses. This requires at least two events and a diagnosis.
Original Language	Make the appropriate selection to indicate the original language the event was reported in.
Description as Reported	Enter the verbatim term used by the reporter, or patient, to describe the adverse event. As you type, the term is automatically copied under Description to be Coded. Verbatim English translations of foreign languages may also be entered here.
Diagnosis/ Symptoms	Make the appropriate selection to indicate whether the event is a diagnosis or symptoms.
Medical Confirmation by HCP	Make the appropriate selection to indicate whether the event is medically confirmed by a HCP. This drop-down has the values: Yes, No, and Blank.
Term Highlighted by Reporter	Make the appropriate selection to indicate whether the primary source reporting the event considered it a major concern or reason for reporting the case. If the information was not explicitly provided by the initial reporter the term should not be considered a highlighted term. The seriousness of the reaction/event should be based on the ICH E2A criteria. Note: Selecting Yes does not mark this case as Serious automatically.
Description to be Coded	If necessary, the verbatim term can be modified in this field. For example, the original term may need to be split, or enhanced with an anatomical location. The Administrator can prevent manual encoding of the description. If automatic encoding is enabled, the term can be auto-encoded to the included term level.
Onset Date/Time	Enter the date/time when the event started. Enter a partial date if the full date is not available.
Onset from Last Dose	This field is calculated automatically from the event onset date and most recent stop date listed in the dosage regimen details of the suspect drug(s). You can also enter or modify the field manually. This field is removed if the dosage regimen is ongoing.
Stop Date/Time	Enter the date/time when the event stopped.
Duration	This field is calculated automatically from the event start and stop dates. You can also enter or modify the duration manually.
Onset Latency	This field is calculated automatically from the earliest first dose date of the suspect drug(s) to onset date. You can also enter or modify the duration manually. Note: Onset Latency = Onset Date - First Dose.
Receipt Date	Enter the date on which information about this event was received by your company.
Patient Has Prior History?	Make the appropriate selection to indicate whether the patient has had a prior history or has suffered from the same event in the past.
Treatment Received?	Select Yes, No, or Unknown.
Intensity	Select the category of severity of the event. The Administrator can adjust this list.
Frequency	Select the frequency of the event from the list. The Administrator can adjust this list.
Outcome of Event	Select the outcome of the event. The Administrator can adjust this list. If Fatal is selected, Death is selected in the list of seriousness criteria. Note: If the Death check box is subsequently cleared, the outcome still remains fatal.
Country in which event occurred	Select the country in which event occurred.
Lack of Efficacy	Check this check box, if applicable.
Progression of Disease	Select this check box, if appropriate.
Adverse Drug Withdrawal Reaction	Check this check box, if applicable.
Infection	Check this check box, if an infection has occurred.
Emergency Room Visit	Check this check box, if applicable.
Physician Office Visit	Check this check box, if applicable.

Understanding the Diagnosis-Event Relationship

Argus Safety allows you to group events in a case, and/or to associate them with particular diagnoses. These determinations can be made by your company or simply as reported to your company. This feature aids significantly in the interpretation and review of individual case reports. It is also useful in summary reports as it enables the reporting of diagnoses only, while retaining database records of individual event terms.

Click the Relationships button in the Event Information section of the Eventstab to open the Diagnosis-Event relationship dialog.

Note:

To use this feature, the case must contain at least two events and, at a minimum, one diagnosis. The events related to a diagnosis are listed on top in this dialog and the symptoms are indented with respect to the diagnoses. You can group events together and associate them with individual diagnoses.

Associating a symptom with a diagnosis

Click the up or down arrows to associate a selected symptom with a diagnosis. In Argus Safety Web, select the symptom and click Move Up or Move Down.

Example:

Such Adverse Events (AE) might be entered into the database as follows:

This example demonstrates how defining a diagnosis-event relationship can clarify an adverse event report. Suppose an initial case report describes a patient suffering from "Somnolence," "Sore Throat," and "Fever."

AE # Diagnosis AE Term (Associated AEs)

1 Somnolence

2 Sore Throat

3 Fever

For reports on all events, they would appear on a CIOMS-I form as:

Somnolence [SEDATION]
Sore Throat [SORE THROAT NOS]
Fever [PYREXIA]

Suppose a follow-up report then supplies information that the patient also had neutropenia, and had been diagnosed as suffering from agranulocytosis (the cause of the sore throat and fever). The somnolence was considered to be co-incidental, and unrelated to any other adverse events.

Neutropenia and agranulocytosis would be entered onto the system, and a diagnosis-event relationship established as follows:

AE #	Diagnosis AE Term (Associated AEs)
1	Yes agranulocytosis
2	(sore throat)
3	(fever)
4	(neutropenia)
5	Somnolence

These events would appear on a CIOMS I form as:

AGRANULOCYTOSIS
[AGRANULOCYTOSIS] ([SORE THROAT],
[PYREXIA NOS], [NEUTROPENIA])
Somnolence [SEDATION]
This immediately gives a clear clinical picture of the case.

Using the MedDRA Browser

The MedDRA application searches the term dictionary for a match at the Lower level term or at the Synonym level. If a match is found, the following fields are automatically populated: Term code, Preferred Term, Included Term, High Level Term, Group Term and Body System/SOC.

Click the icon to view the MedDRA Browser.

Configuring Regulatory Reporting Rules

The regulatory reporting rules can be configured to look at any type of criteria but are mainly configured to look at Seriousness, Listedness, Causality, and Outcome. Out of these, Listedness and Causality can be captured and controlled (using the event assessment section) down to an individual license basis.

This granularity allows individual license holders to override the normal listedness and causality assessment to control the need for submissions to their local regulatory authority. Each affiliate could either suppress the need for a report by demoting the criteria, or add the requirement for a report by promoting the listedness or causality.

This serves to promote the global reporting automation while maintaining the level of individual local affiliate control that is often needed.

Note:

To obtain an assessment of the adverse event, the product must be in the company's suspect product and the event must be encoded.

Event Coding Section

The Event Coding section enables you to enter information about the event. The following is an illustration of the Event Coding section.

Surrounding text describes eventcoding.gif.

The following table lists and describes the fields in the Event Coding section.

Field/Control Name	Description
Body System/SOC	Displays the body system or System Organ Class. This item is automatically entered from the event dictionary that is used and it cannot be edited.
Lower Level Term	Displays the ART code. If you have appropriate access rights, click Encode to view the associated coding dialog.
Preferred Term	Displays the preferred term. This item is automatically entered from the event dictionary that is used and it cannot be edited.
Preferred Term Code	Displays the preferred term code. This item is automatically entered from the event dictionary that is used and it cannot be edited.
High Level Term	Displays the High Level Term when the MedDRA coding dictionary is used. This item is not displayed when event encoding is done using the WHO-ART dictionary. This field cannot be edited.
High Level Group Term	Displays the high-level group term when using the MedDRA coding dictionary. This field is not shown when coding with WHO-ART. This field cannot be edited.

Seriousness Criteria Section

The Seriousness Criteria section enables you to identify how serious the event was. For example, did the result in death or was it life threatening. The following is an illustration of the Seriousness Criteria section.

Surrounding text describes seriousnesscriteria.gif.

Seriousness Criteria Fields and Field Descriptions

The following table lists and describes the options in the Seriousness Criteria section.

Field/Control Name	Description
Death	Displays the Death Details dialog Note: If you un-check the Death option in the Seriousness Criteria, you are required to confirm the deletion of the death details.
Hospitalized	Displays the Event Hospitalization dialog.
Medically Significant	Select this check box to display the seriousness as medically significant.
Life-threatening	Select this check box to display the seriousness as life-threatening.
Disability	Select this check box to display the seriousness as a disability.
Intervention Required	Select this check box to display the seriousness as requiring intervention.
Congenital Anomaly	Select this check box to display the seriousness as a congenital anomaly.
Other	Select this check box to enter explanatory text. It is mandatory to enter text, specifying the Other Seriousness Criteria.

Entering Death Details

Use the following procedure to enter details about a death.

Select the Death check box under Seriousness Criteria.
The form for Event Death Details appears.
Enter information for the items in the form.
Click OK to save the entered Death Details.

The following table lists and describes the fields in the Event Death Details section.

Field/Control Name	Description
Death Date	Enter the date of death. You can enter a partial date if the exact date is unavailable.
Autopsy Done?	Make the appropriate selection.
Cause of Death	Enter a term to describe the cause of death. Click Encode to display the associated encoding dialog.
Autopsy Results Available?	Make the appropriate selection.
Autopsy Results	Enter Information about the autopsy results.

Note:

When Seriousness criteria Death is unchecked, the system displays a message Do you wish to delete the Death Details?.On confirming, the Death date (NF or date) and Autopsy details are cleared .

Entering Hospitalization Details

Use the following procedure to fill out the Hospitalization Details form.

To complete the Hospitalization Details form

Select the Hospitalized check box under Seriousness Criteria.
The form for Hospitalization Details appears.
Enter information for the items in the form.
Click OK to save the entered Hospitalization Details.

The following tables lists and describes the fields in the Hospitalization Details form.

Field/Control Name	Description
Hospital Name	Enter the hospital name associated where the adverse event occurred.
City	Enter the city in which the hospital is located.
State	Enter the state in which the hospital is located.
Hospitalization Start Date	Enter the first date of the patient's hospitalization associated with this adverse event. If the exact date is not available, you can enter a partial date in this field.
Hospitalization End Date	Enter the last date of the patient's hospitalization associated with this adverse event. If the exact date is not available, you can enter a partial date in this field.
Duration of Hospitalization	This field is automatically calculated by the system, based on the start and end dates entered. This field is calculated using 24-hour increments. You can also manually enter the number of days the patient was hospitalized.
Event caused initial hospitalization	Select this check box if the event is associated with the initial hospitalization of the patient.
Event prolonged hospitalization	Select this check box if the event prolonged hospitalization.
Discharge summary available	Select this check box if a discharge summary is available.

Nature of Event Section

The Nature of Event section enables you to identify the nature of the event from the drop-down list. You can add a maximum of 50 such Nature of Event rows.

Surrounding text describes natureofevent.gif.

Details Section

This section enables you to enter notes related to the event. If Reported Causality is entered when the case is booked-in, the system automatically transfers it to this field. The following is an illustration of the Details section.

Surrounding text describes detailssect.gif.

Event Assessment

The Event Assessment tab enables you to capture causality and listedness information for a case. All encoded events in the case are compared with the listed events for company products (agents) associated with the case. The following is an illustration of the Event Assessment tab.

Surrounding text describes eventassessmenttab.gif.

Event Assessment Tab Fields and Field Descriptions

The following table lists and describes the fields on the Event Assessment tab.

Field/Control Name	Description
Recalculate	Refreshes the Event Assessment section with the newly entered data if new suspect products or events are entered, or the Event Relationship is modified.
Product	This field is populated when events are entered in the Products tab and is displayed in the following format: First Line - Product Name Second Line - Generic Name
Causality as Reported/Source	This field provides the source of causality as reported such as Investigator, MAH, Healthcare Professional, and so on
Method	This field provides the method used for causality determination.
Result	This field indicates the result of the causality as reported.
Causality as Determined/Source	This field provides the source of causality as determined.
Method	This field provides the method used for As Determined Causality.
Result	This field indicates the result of As Determined Causality.
Other Causality / Source	This field specifies the source of other causality.
Method	This field provides the method used for other causality.
Result	This field indicates the result of other causality.
Event	This field is populated when events are encoded and are displayed in the following format: First Line - Event PT (Verbatim) Second Line - LLT
D/S	Displays the Diagnosis/Symptom details by D or S in line with the Events.
Seriousness Severity Duration	Displays the Seriousness, Severity and the Duration of the Event.
Datasheet	Displays the datasheet(s) for the agent.
License	Displays the license(s) for the agent.
As Determined Listedness	Indicates whether the system found the event on the datasheet for this product.

Filtering in the Event Assessment Tab

The following table lists and describes how the system filters each field on the Event Assessment tab.

Field/Control Name	Description
Product	The product filter drop down list contains all products listed in the event assessment. The user can filter on all the products which are present in the Event Assessment dialog.
Event	Contains a drop down of values of distinct Event PT. The user can filter on all the products which are present in the Event Assessment dialog.
D/S	Contains a drop down values of D for Diagnosis or S for Symptoms.
Datasheet	Contains a drop down of values of distinct Datasheets.
Licenses	Contains a drop down of values of distinct Countries of the Licenses.

Note:

Only the assessment rows that match the selected criteria display in the filtering results.

User Actions on the Event Assessment Tab

The following table list user actions and the results of those actions.

User Action	Result
Click Datasheet column's icon	The system does the following: Displays the license view Displays the datasheet view Displays the License column Enables the icon for the License column
Click Product Name link	Displays the name for the selected product
Click Event Description link	Displays the Event Information for the selected event
Click License Description link	Displays the license description as defined in the License Configuration
Click Datasheet Description link	Displays the first 1000 terms in the datasheet. Click Print to view all the terms and click Export to export all the labeled terms to an Excel file in a single column with column header as Labeled Terms.

Product-Event Details Tab

The Product-Event Details tab enables you to capture causality information for a case. The following is an illustration of the Product-Event Details tab.

Surrounding text describes prodevntdtls.gif.

Product-Event Details Tab Fields and Field Descriptions

The following table lists and describes the fields on the Product-Event Details tab.

Field/Control Name	Description
Product	This field is populated when events are entered in the Products tab and is displayed in the following format: First Line - Product Name Second Line - Generic Name
Causality as Reported/Source	This field provides the source of causality as reported such as Investigator, MAH, Healthcare Professional, and so on
Method	This field provides the method used for causality determination.
Result	This field indicates the result of the causality as reported.
Causality as Determined	This field is populated automatically, along with the information entered in the Reported Causality field.
Other Causality Source	This field defines the source of causality calculation.
Event	This field is populated when events are encoded and are displayed in the following format: First Line - Event PT (Verbatim) Second Line - LLT
Most Important Diagnosis?	Select Yes or No.
Event more specific/severe than PT?	Select Yes or No.
Onset from First Dose	This date is defined as the earliest regimen start date to Onset, and is completed automatically.The Date calculation based on the Case Form Calculation for Inclusive or Exclusive.
Onset from Last Dose	This date is defined as the latest regimen stop date to Onset, and is completed automatically.The Date calculation based on the Case Form Calculation for Inclusive or Exclusive.
Total Dose to Event	This value is calculated automatically, based on daily dose and duration.
Units	Units are provided automatically based on the dosage units entered.
Action Taken	Select the appropriate term from the drop-down list.
Other	This value can be entered only when the Action Taken is Other.
Dechallenge Results	Select the appropriate option.
Rechallenge Results	Select the appropriate option.
Event Occurred as a Consequence of	Select the appropriate option.
Term	Select the appropriate option.

Analysis Tab

The Analysis tab enables you to generate or view a narrative description of the case, together with other notes. In addition, it also enables you to enter information required for generating the MedWatch 3500A, BfArM, and AFSSaPS reports.

The typical users of this tab are responsible for:

Making a medical assessment of the case
Approving the case for completeness and accuracy.

The following is an illustration of the Analysis tab.

Surrounding text describes analysistab.gif.

Case Analysis Section

The Case Analysis section of the Case Analysis tab enables you to enter narrative information about the adverse event. The following is an illustration of the Case Analysis section.

Surrounding text describes caseanalysissect.gif.

Case Analysis Fields and Field Descriptions

The following table lists and describes the fields in the Case Analysis section of the Case Analysis tab.

Field/Control Name	Description
Narrative	Click Generate to generate an auto narrative. This feature is configured by the Administrator. If you are not utilizing the auto narrative feature, enter the narrative here. The narrative is printed on expedited reports.
Case Comment	You can enter comments in this area. If you are not permitted to edit the auto narrative, you can use this field to provide additional details important to the interpretation of the case. Comments appear on certain expedited reports.
Abbreviated Narrative	Enter brief comments in this field. This item maps only to the PSUR report.
Local Evaluator Comment	Enter the comments provided by the local evaluator.
Company Comment	Enter comments in this area. This information does not appear on expedited reports.
Evaluation in light of similar events in the past	Enter an evaluation comment that takes in to consideration similar events that have occurred in the past.

Using Auto Narrative Templates

You can select an Auto Narrative template for the Narrative, Case Comment, Abbreviated Narrative, Company Comment, and Evaluation in light of similar events in the past.

To generate or add narrative templates

Click the button to view the Custom Auto Narrative Templates dialog.
Select the required Autonarrative from the list.
Click Append to append this Autonarrative to the existing narrative.
Click Append if this is the first narrative being added to the text area.
Click Replace to replace the existing narrative with the selected narrative.

Note:

You cannot modify the Autonarrative text if the Administrator has configured the system to prevent modification of the Autonarrative.

If an Autonarrative template has been configured in multiple languages, icons representing the languages display above the text area.

Viewing Differences in Case Narratives

The system enables you to view the differences in case comments from previously locked versions of the case. To view these differences, click the Show Difference button in the Case Comments section of the Analysis Tab.

When you choose to view the differences in the two narratives, the system does the following:

Displays the differences in red with a strike out and a yellow highlight.
Displays additions to the narrative in black with green highlights.
The Narrative is read-only and you cannot modify it.
Use the zoom dialog to adjust the font size.
The system displays the last revision number of the case and date and time stamp in the following format:
(Last revision # X as of YYYY MMMM)

where:

X Is the revision number of the last case

YYYY Is the date the case was locked

MMMM Is the time the case was locked in 24-hour format.
The system disables the button if there is no previously locked version of the case.
This function is also available on the Medical Review dialog.

Case Summary Section

The Case Summary section of the Case Analysis tab enables you to enter summary information about the adverse event. The following is an illustration of the Case Summary section.

Surrounding text describes casesummarysection.gif.

Case Summary Section Fields and Field Descriptions

The following table lists and describes the fields in the Case Summary section of the Case Analysis tab.

Field/Control Name	Description
Case Serious	This list indicates whether the overall adverse event case is serious or non-serious. This assessment is automatically performed by the system from the Seriousness Criteria of the Events tab. If any of the Seriousness Criteria was selected for any event in the Event tab, Yes is selected automatically in the list. No is selected if the Seriousness Criteria is cleared for all events in the Events tab. You can modify the selection after entering a justification, if you have the access rights to do so.
Serious Notes	A justification for overriding the system determination will be displayed in the Notes area. A green dot will appear adjacent to the Notes area. Click the green dot to revert to the automatic calculation for seriousness or to view the overriding notes.
Company Agent Causal	The system automatically determines this value from the As Determined causality in the Event Assessment section. This field is displayed as Yes if the As Determined causality is Yes and vice versa. If the As Determined causality is Unknown, this field will be Yes.
Case Causal Notes	A justification for overriding the system determination is displayed in the Notes area. A green dot is displayed next to the Notes area. Click the green dot to revert to the automatic calculation for seriousness or to view the overriding notes.
Listedness Determination	The value for this field is calculated from the Event Assessment section in the Events tab. If any row there shows Unlisted under the Listed column, this value is set to unlisted.
Listedness Determination Notes	A justification for overriding the system determination is displayed in the Notes area. A green dot appears adjacent to the Notes area. Click the green dot to revert to the automatic calculation for seriousness or to view the overriding notes.
Case Outcome	The value for this field is also calculated from the Events tab. If the outcome for any event is Fatal, the case outcome is set to Fatal. If the case outcome is changed here, that change is not made to the event outcome in the Events tab.
Company Diagnosis/Syndrome	The company diagnosis or syndrome is entered in this field.
Notes	A justification for overriding the system determination is displayed in the Notes area. A green dot is displayed adjacent to the Notes area. Click the green dot to revert to the automatic calculation for seriousness or to view the overriding notes.

Analysis Tab: MedWatch Info Tab

The MedWatch Info tab enables you to enter additional details required for the MedWatch 3500A Drug Report. The following is an illustration of the MedWatch Info tab.

Surrounding text describes medwatchinfo.gif.

MedWatch Info Tab Fields and Field Descriptions

The following table lists and describes the fields on the MedWatch Info tab. Be aware that the values in the Form section column refer to specific sections of the MedWatch 3500A Drug Report form.

Form Section	Field Description
B1. Adverse Event / Product Problem	Select the applicable check boxes. Select Adverse Event when a product is suspected to have caused an adverse outcome in a patient. Select Product Problem when the defect or malfunction in the product could lead to a death or serious injury. Select both check boxes if a malfunction or product problem caused a death or serious injury.
C9. Suspect Medications (NDC#)	Enter the National Drug Code if you have selected the Product Problem check box.
F1. User Facility or Importer	Indicate whether this report is from a user facility or an importer. You can suppress printing of Block F of the MedWatch 3500A report by selecting Suppress Block F Printing.
F2. UF/Dist report number Consider UF / Importer data from	Enter the complete number of the report exactly as entered in the upper right corner of the front screen. Select User Facility or Importer information from Case Form of from Reporting Destination.
F3. User facility or Importer Name Address1/Address 2/City / State/ Country/Postal code	Enter the full name and address of the user facility or distributor reporting site.
F4. Contact person Sal/First Name/MI/Last Name	Enter the full name of the medical device reporting (MDR) contact person. This is the person who is designated as the device user facility/distributor contact for this requirement. The FDA will conduct its MDR correspondence with this individual. The contact person may or may not be an employee of the facility. However, the facility and its responsible officials will remain the parties ultimately responsible for compliance with MDR reporting requirements.
F5. Phone number	Enter the phone number of the medical device reporting (MDR) contact person.
F6. Date aware of event	Enter the date that the user facility's medical personnel or the distributor became aware that the device may have caused or contributed to the reported event.
F10. FDA codes Patient FDA Device Codes	Click the first row and column of the FDA Patient and Device Codes section and then click Select. You can enter up to six FDA Patient Codes. If the entered code is not present in the FDA Codes list, it is erased.
F11. Report sent to FDA	Select this check box if a report has been sent to the FDA. If you select it, enter the date when the report was sent to FDA.
F12. Location where event occurred	Select the location of the actual occurrence of the event.
F13. Report sent to mfr?	Select this check box if a report has been sent to the manufacturer. If you select it, enter the date when the report is sent to manufacturer.
G3. Report Source	Select the Report Source check boxes as applicable, to match all report sources specified with the Reporter Type. See the following guidelines for selecting the check boxes.
G5. PLA# Pre-1938 / OTC Product	Enter the PLA number. If the product pre-dates 1938, select Pre-1938. If the product is an over-the-counter product, select OTC product.

Guidelines to Selecting G3 Report Source Checkboxes

The following table provides information about the conditions that govern when a specific check box should be selected.

If this condition is true	Select the following check box
Country of Incidence is not USA.	Foreign
Report Case type is configured to contain cases from Literature.	Literature
Report Case Type is configured to contain cases from Clinical Trials.	Study
Any reporter with Health Professional set to Yes	Health Professional
Any Reporter Type is selected as Company Representative.	Company Representative
Any Reporter (Primary or Other) exists in a case with a Reporter Type of Other, If the selected Report Type is a Regulatory Authority (text value) within the Argus Case, the Other check box should be checked and the text Regulatory Authority should be entered in the text box.	Other
Any Reporter Type is selected as Consumer AND none of the reporters is identified as Health Care Professional.	Consumer

Note:

The User Facility and Distributor check boxes must be checked manually.

Enter the appropriate text if you have selected Other as a report source.

Analysis Tab: BfArM Info Tab

Use the BfArM Info tab to enter information required for the BfArm Report. The following is an illustration of the BfArM Info tab.

Surrounding text describes bfarminfotab.gif.

To enter data for the BfArM report

Open the BfArM Info tab.
Select the choices that apply to the patient from the items in the form.
If you do not know if a particular condition applies for the patient, select Unk.

Note:

If any of the relevant items are entered in the Current Medical Status form in the Patient tab, the system automatically enters them here. If you change any of those items in the BfArM Info tab, the system will not enter the data in the Patient tab.

Analysis Tab: AFSSaPS Info Tab

Use the AFSSaPS Info tab to enter the imputability assessment information for the suspect product along with the Adverse Events. The following is an illustration of the AFSSaPS Info tab.

Surrounding text describes afssapstab.gif.

AFSSaPS Info Tab Fields and Field Descriptions

The following table lists and describes the fields on the AFSSaPS Info tab.

Field/Control Name	Description
Event	Displays included terms for all events.
Product	Enter the suspect product. You cannot enter a concomitant product.
Chronology	Select a Chronology code. The fixed set of values is C0, C1, C2, and C3. Click the icon to select the Time to onset, Readministration and Drug Stopped Values. The user's selection auto-calculates the Chronology for the Product - Event combination.
Semiology	Select a Semiology code. The fixed set of values is S1, S2, and S3. Click the icon to select the Semiology Outcome, Complementary Test, and Other Explanation. The user's selection auto-calculates the Semiology for the Product - Event combination.
Bibliography	Select a Bibliography code. The fixed set of values is B0, B1, B2, and B3.
Imputability	Imputability Calculation:
~	Select from one or more of the following checkboxes: Poursuite de l'étude sans modification du protocole Poursuite de l'étude avec amendement au protocole Arrêt de l'étude Arrêt du développement du produit Autres The text box after Autres supports fifty characters. If the Autres checkbox is not checked, the field is disabled. You can click Copy to Local Evaluator Comment to copy imputability values to the Local Evaluator Comment field and place the imputability text-equivalent at the beginning of the text that currently exists in the field. Copy to Local Evaluator Comment is visible only if the language for the "Local Evaluator Comment" field is French.
Future Actions	Enter a text description for future actions.

Activities Tab

The Activities tab presents detailed information about the contact log, routing comments, action items, and Case Lock/Closure.

The following is an illustration of the Activities tab.

Surrounding text describes activitiestabcompressed.gif.

Activities Tab: Contact Log Section

The Contact Log section of the Activities tab enables you to:

Track correspondence related to individual cases

Display scheduled letters

The following is an illustration of the Contact Log section of the Activities tab.

Surrounding text describes contactlogsection.gif.

The following table lists the different icons that appear for letters:

Icon	Description
Letter envelope icon with a Blue Arrow to the right	Clicking on the email button opens a message editor.
Double Overlapping Letter Envelope Icon	Indicates Letter scheduled awaiting to be sent.
Letter Envelope icon with a Red Exclamation Mark	Indicates that the letter is overdue (Date Open > System Date)
Letter Envelope icon with a Green Exclamation Mark	Indicates mail success status.

Contact Log Fields and Field Descriptions

When using the Contact Log section, be aware of the following:

The number displayed in parenthesis in the header of each section - Contact Log, Action Item, Routing Comments, Case Lock/Archive - displays the total number of entities within the section.

You can choose to view All Action Items or only Open Action Items, which display all the Open Action items within the case. By default, All Action Items are displayed.

You can sort Action Items by clicking on the column headers.

The system remembers the sort order on for the duration of the case.

The following table lists and describes the fields in the Contact Log section of the Activities tab.

Field/Control Name	Description
Date	The date is automatically inserted by the system when a letter is scheduled or generated through the Letters menu. You can enter the date on which the letter is manually scheduled or generated. Click the letter icon to open the Letter Preview dialog. This allows you to view a letter or to modify it if it has not been sent already.
Code	Select from a list of values to set the contact code for this entry. The Administrator can adjust the information in this list.
e-mail button	Click to send an e-mail message.
Description	Enter a brief explanation for the letter, for example, "Initial Letter," or the details of a phone conversation.
New Letter button	Click this button to generate a new letter.
Group/User	Select a group responsible for the Contact item. From the list below, select a user from the selected group who will be responsible for the action. The Contact Item will appear in the Worklist for selected user. If "Any" is chosen as the group, the Action Item appears in all the users' Worklist. The Administrator can adjust the information in these lists.
Date Sent	The date is automatically inserted when a letter is sent through the letter menu. You can also manually enter the date the letter was sent. If this field is completed, the letter will become read-only.

Generating Letters

You can generate letters from the Contact Log section. When generating letters, be aware of the following:

The placeholders for the original letter template can be replaced by information that is specific to the current case.
A letter is only added to a search if the Correspondent check box is checked.
The Administrator can configure the system to generate letters automatically and to schedule them for a specific number of days after receiving details of an adverse event. For example, the system might schedule an Initial Response Letter to be sent the day after an adverse event is received. Auto letter scheduling is triggered when a case is initially saved.
Letters cannot be auto-generated unless the "Date" [contact log date] is reached, to ensure that the latest information for the case has been updated to the letter.
If the Primary Reporter is marked as a correspondence contact, the system sends Auto-scheduled letters are sent to the Primary Reporter. Otherwise, the letter is sent to the first correspondence contact.
Auto-scheduled letters appear in the Contact Log section of the Case Form. You can view or print them by double clicking the letter icon. You can also edit letters that have not been sent. The system does not automatically send letters. You must send or remove letters manually.
In addition to auto-scheduling letter, you can also configure auto action items, which prompt you to follow-up with a correspondent after a letter has been scheduled and sent. Auto action item scheduling is triggered once the sent date has been entered for a letter. Auto action items appear in the Action Items section on the Case Form and in the Action Items tab of the Worklist.
The system uses the following naming convention to when saving letters in the Uploaded letters folder:

XXXX_YYYY.RTF

where:

XXXX Is the current case number

YYYY Is the current letter numbering format (i.e., date and time the letter was generated)
The system replaces all special characters in the case number with an underscore ( _ ) character.
The CFG_PLACEHOLDER SQL limit is 4000 characters rather than 1000.

To create an RTF document with placeholders, you need to configure it through Argus Console > Code List > Letter Configuration. The details of this configuration are available in the Argus Console Guide under the Configuring letter (RTF) templates section.

The following image displays the meaning/status of various letter icons:

Surrounding text describes lettericons.jpg.

Use the following procedure to generate a letter:

To generate a letter

Go to Contact Log in the Activities tab and click New Letter.
The Custom Letter Templates dialog opens.
Select the required letter template from the list and click OK to open the letter in a separate window.
Make the necessary changes to the letter text.
Select File-->Save to save the changes.
If you modified the letter, select Yes.

This attaches the letter to the Case Form by browsing to the location where you saved the changes.
After saving the letter, the system displays it in the Contact Log section of the Activities tab.
The system creates an action item for following-up on this letter in the Action Items section of the Activities tab.

Scheduling Action Items for Letters

When specifying or changing the Date Sent field in a letter, you can schedule an action item if you wish to do so.

If an action item is not specified, the field is blank.
Any Action Item can be updated on the screen immediately after a case has been saved.
Unless the Action Item has already been marked as completed, each time the Date Sent field is changed for a letter, the corresponding action item (if one exists) is also updated with a new Due Date of Date Sent of the Letter and the number of days specified for the Action in the Letter configuration

Opening a Message Editor

To open a message editor

Click the letter icon to open the message editor.
The system opens the message editor.

The following table lists and describes the fields in the dialog box

Field/Control Name	Description
To	Displays the e-mail address specified for the Primary Reporter in the Case Form. You can edit this field.
From	Displays the email address specified in the Return Email Address in Argus Console>Code Lists>Letter Configuration. You can edit this field also.
Subject	Displays the Case Number and the Description of the Contact log. You can edit this field.
Send	Enables you to send the e-mail to the intended recipient.

Activities Tab: Action Items Section

The Action Items section enables you to view or enter details of action items for the case and to assign responsibilities for actions. The following is an illustration of the Action Items section.

Surrounding text describes actionitemssection.gif.

Action Items Fields and Field Descriptions

The following lists and describes the fields in the Action Items section.

Field/Control Name	Description
Date Open	Enter the date the action item was created. Open action items appear in the Worklist of the user who is responsible for the action item. They also appear in the Open Action Items Report.
Code	Select an Action Item code from the drop-down list. This will display the description of the selected Action Item Code. The Administrator can adjust this list.
Description	Selecting an Action Item code automatically enters information into this field. The text can be modified as required. The Administrator can adjust this list.
Group/User	Select a group responsible for the Action Item from the given drop-down list. From the drop-down list below this, select a user from the selected group who will be responsible for the action. The Action Item will appear in the Worklist for the selected user. If "Any" is chosen as the group, the Action Item appears in all the users' Worklist. The Administrator can adjust these lists.
Due	Enter the date on which the action item is to be completed.
Completed	Enter the date on which the action item was completed. A red border indicates a completed action item while a green border indicates an incomplete action item.
Sent in Letter	Identifies that the Query Type Action item has been sent as a part of the Letters. Displays only for those Action Items that are configured as "Query Action" in Console ' Action Type code list.

Activities Tab: Routing Comments Section

The Routing Comments section displays workflow routing information and comments for the case. It also contains a read-only sub-section on Case Locking/Closure. The following is an illustration of the Routing Comments section.

Surrounding text describes routingcommentssection.gif.

Routing Comments Fields and Field Descriptions

The following table lists and describes the fields in the Routing Comments section.

Field/Control Name	Description
Date	Displays the date the case was routed to a new workflow state. This field is automatically generated when a case is routed.
User	Displays the name of the user who routed the case. This field is automatically generated when case is routed.
Comment	Displays the routing comment.
Route button	Routes the cases.
Return button	Returns the case to the previous state.

Routing Cases

If the case meets the routing rules specified by the Administrator, you can use the Case Routing dialog box to route a case to the next workflow state. When using the Routing Forward Cases function, be aware of the following:

Non-Enterprise Workflow managers cannot view all the Workflow States below the line if the Workflow States are assigned to Sites in the Workflow Configuration.
Only Enterprise Workflow managers have access to all sites for routing cases ahead in the Workflow.
If the Workflow state does not have defined site, all workflow managers can see it.

To route a case

Click Route in the Activities tab of the Case Form to open the Case Routing dialog box.
From the Route to Next State drop-down list, select the state to which you would like to route the case.

If only one workflow state can be selected for the Next Route state, that state can be selected by default in the Route to Next State field.
From the Route to User drop-down list, select the user or user group to route the case to.
Enter the routing comments in the Comments field.

OR

Click Select to select a comment from a list of pre-defined routing justifications.

Routing Comments Log and Case Print

Local Lock/Unlock details are displayed as part of the Routing Comments log in Case Form > Activities tab.

It displays the Date of local lock/unlock, User who performed the local lock/unlock similar to the existing global lock functionality. The text "Case Locally Locked for JP" or "Case Locally Unlocked for JP" is populated before the user added comments in the Local Lock screen, corresponding to the Local lock or unlock action. Note "JP" is the standard A2 country code for the country Japan defined in the Argus Console > Countries code list.

When a case is globally/locally locked or globally/locally unlocked at the same time, only one entry is added to the Routing Comments log.

The text "Case Globally and Locally Locked for JP" is added for single lock operation.

The text "Case Globally and Locally Locked for JP" is added for sngle unlock operation.

The system records the corresponding routing comments described above even in scenarios where the system user (e.g., AGservice) performed the local lock/unlock action.

To select text from the pre-define list of routing justifications

Click on the Select button in the Case Routing dialog to open the Routing Justification dialog box.
Select the required justification from the justification list displayed under Select a standard justification for this field. The system highlights the selected row.
Click OK.
The system closes the Routing Justification dialog box and displays the selected justification text in the Comments field in the Case Routing dialog box.
Click OK to route the case.

Note:

The system displays disabled users in the user drop-down list in alphabetical order with an asterisk (*) at the end. You can view the total number of times the case has been routed in the header section, excluding the blank rows.

Returning Cases

If necessary, you can return a case to its previous workflow state.

To return a case to its previous workflow state

Open the case.
Click the Return button in the Activities tab of the Case Form.
When the system opens the Case Routing dialog box, enter your password in the Password field.
From the Route to User drop-down list, select the user or group the case needs to be returned to.
Enter any routing comments in the Comments field.
Click OK to return the case to its previous workflow state.

Activities Tab: Case Lock/Close Section

The Case Lock/Close section enables you to lock a case, unlock a locked case, and formally close a case. You must lock the case before you can generate a report. The following is an illustration of the Case Lock/Close section on the Activities tab.

Surrounding text describes caselockclosesection.gif.

When closing a case, be aware of the following:

If the Auto-schedule Later checkbox for expedited reports is checked and you try to archive a case, the system displays the following message:

Case xxxx cannot be closed while Auto Schedule Later is checked. Please uncheck the option for the Auto Schedule Later option on the Regulatory Reports tab or wait for the Report Scheduling to complete before attempting to archive the case.
The system displays this same message when you close single or multiple cases from the New/Open dialog on the Worklist.

Case Lock/Close Fields and Field Descriptions

The following table lists and describes the fields in the Case Lock/Close section of the Activities tab.

Field/Control Name	Description
Case Status	Enables you to unlock, lock, or close a case after entering the appropriate user information. Unlock -- Enables you to unlock a case if you have the appropriate permissions. To unlock a case, enter the password you use to log on to Argus Safety. Lock -- Enables you to lock a case if you have the appropriate permissions. The current date will be used for the lock date. To lock the case, enter the password you use to log on to Argus Safety in the Case Locking dialog box. Close -- Enables you to close a case if you have the appropriate permissions. To close the case, enter the password you use to log on to Argus Safety in the Case Closure dialog box. Note: Auto-archiving a case is not allowed if any local or global reports are pending for generation. If a user tries to close a case for which Local Reports have not yet been submitted (through this Case Status field here), the application will display a message that the case cannot be closed due to reports needing submission.
Closure Date	Date on which the case was locked or closed. If a locked case is being viewed by a user, any other user who tries to access the same case will have read-only access to the case. Cases should be closed only after all action items for the case are complete, all expedited regulatory reports have been submitted, and all the expected follow-up information has been received. If a closed case that is closed requires modification, the case must be re-opened by using the password. A case may be either locked or closed, but not both. A locked case will be moved from the locked state to the closed state without having to unlock first. Note: Case closure should not be confused with closing the Case Form. Closing of the Case Form refers to removing the current Case Form from the screen.
Lock or Closed By	Displays the name of the user who locked or closed the case.
Notes	Displays relevant information about the case lock or closure.

Local Locking

When a user clicks on the Local Lock icon on a case that has been Global Locked but is pending Local Lock for Japan, the system displays a pop-up dialog to validate the user who attempts to perform the local lock on the case.

Enter the password and notes to perform the local lock on the case.

When a user clicks the Local Lock icon on a case that has already been Local Locked for Japan, the system checks that the common profile switch "Enable Local Unlocking" for the current enterprise is set to "Yes". If this option is set to "No", it displays a message that the "Local Unlocking feature is not enabled".

If the option is set to Yes, first check if the case has any Local Japan report, that are pending generation, and displays a warning message.

If there are no Local Japan report that are pending generation, the system prompts the users with Case Local Unlock dialog on whether they want to proceed with Local Unlock.

On clicking Yes for Local Unlock, the system validates the user again.

After the user has been validated, the system stops any local Japan report that is pending generation from being generated and enables all the Local Fields for editing.

The following table lists the different lock statuses in the application and their meanings/descriptions :

Lock Status with Icon	Description
Global Locked	Denotes a locked case that does not have local reporting needs.
Global Unlocked	Denotes an unlocked case that does not have local reporting needs or where the Local PRPT case is both globally and locally unlocked.
Global Locked and Local Locked	Denotes a Local PRPT case that is locked at both global and local levels for all local countries for the case.
Global Locked and Pending Local Lock	Denotes a Local PRPT case that is locked global but pending local lock for any local country for the case.

Locking a Case

To lock a case:

In the Case Lock/Close section of the Activities tab, click Lock.
The system opens the Case Locking dialog box.
Enter your Argus Safety password in the Password field.
Enter any notes in the Notes field.
Click OK.
The system displays the locking notes in the Notes field of the Case Lock/Close.

Note:

To unlock a case from the Locked/Archived state, select the Unlocked value from the Case Status drop-down list. This will display the Archived Case or Case Lock dialog. The dialog box requires you to specify your password and the reason for unlocking the case. The case is unlocked/archived after you enter this information.

After a case has been globally locked and when a local user (an Argus J user) opens that case, the application allows the local user to enter local data, as follows:

All the local fields remain editable for the Argus J user.

All the existing case form fields and tabs that remain editable after global lock retain the same behavior (irrespective of English or local users).

Any operation that update the global value such as Re-arrange, Add, Delete, Up / Down buttons, Relationships, Copy Japanese to English button, Lab data import is not allowed, retaining the existing behavior on lock. One exception to this is Case Classification field - the Add and Delete buttons shall remain available.

The Copy English to Japanese buttons allow the user to copy information from English to Japanese data entry. Note that no global values shall be updated with copy action.

On global lock, all the qualifying reporting rules will be executed as follows:

All the qualifying Global (i.e., non-Japan) and Japan Local reports will be scheduled.

The Global (i.e., non-Japan) reports shall be generated/transmitted as per the existing functionality.

However, the Japan Local reports cannot be generated before local lock is performed.

One Step Global and Local Lock

In some scenarios, when a Japanese user enters a domestic case, both the local data entry as well as English translation may happen before the global lock, which would necessitate the Global and Local Lock be done in a single step by the Japanese user.

In order to support this scenario and allow the Argus J user to perform the Global Lock and Local Lock at the same time, the system has been enhanced as follows:

When a local user (Argus J user in this release) performs a global lock, the system shall display the existing Case Locking dialog but enhanced with an option to perform Local lock additionally for a Local PRPT case. Note that this functionality shall be applicable for global case locking done from any place via the application's UI including Case Form, E2B, Incoming Review, etc. Note this is not applicable to LAM as this feature is applicable only to the Argus J user type.

This checkbox appears only for a Local PRPT case, when the user has Allow Local Locking configuration enabled under Argus Console > Access Management > Users.

When the user clicks OK on this screen to perform Global Lock and if the Local Lock option is checked, the system shall be enhanced to perform both the global and the local lock for the case.

The following table lists the different lock statuses in the application and their meanings/descriptions :

Lock Status	Description
Global Locked	Denotes a locked case that does not have local reporting needs.
Global Unlocked	Denotes an unlocked case that does not have local reporting needs or where the Local PRPT case is both globally and locally unlocked.
Global Locked and Local Locked	Denotes a Local PRPT case that is locked at both global and local levels for all local countries for the case.
Global Locked and Pending Local Lock	Denotes a Local PRPT case that is locked global but pending local lock for any local country for the case.

Unlocking a Case

Use the following procedure to unlock a case.

To unlock a case

In the Case Lock/Close section, select Unlocked from the Case Status drop-down list.
When the system opens the Locked Case dialog box:
1. Type your password in the Password field.
2. Type any relevant information in the Notes field.
3. Click OK.
When the system opens the Case Unlock dialog box, click one of the following:
- Significant F/U
- Non-significant F/U
- Other

When a user performs global unlock for a case, the system shall check if the case has local or global reports in pending generation state (i.e. "scheduled" and "new data available" states as identified by the configured SQL explained below) or pending lock (for Local PRPT case), as explained below:

The checks for reports pending generation are applicable only when DLP_EXPEDITED_E2B_REPORTS is set to 0 (i.e., DLP is not enabled for Expedited Reporting).

The system checks the value returned by running the SQL (if any) configured in the existing common profile switch "SQL to prevent case unlock when reports are pending generation" under Case Processing (introduced in release 7031). If the value returned is 0 or no SQL has been configured, the system shall allow users to global unlock the case without any of the other checks.

If the value returned is greater than 0, the system behaves as follows:

If the Value of Allow forced unlock (Global and Local) is No and the Report status (Global or Local) is Pending (i.e. the configured SQL returned a value > 0), the case is not unlocked and an error message is shown.

If the Value of Allow forced unlock (Global and Local) is Yes and the Report status (Global or Local) is Pending (i.e. the configured SQL returned a value > 0), a warning message is displayed. The case is unlocked using the existing "Locked Case" dialog if the user selects "Yes" on the warning message.

If the Value of Allow forced unlock (Global and Local) is N/A and the Report status (Global or Local) is Generated /Submitted (i.e., the value from SQL check returned 0 or no SQL has been configured), the case is unlocked, as per its existing functionality.

This switch functions independent of the "Allow Local Lock" privilege and "Enable Local unlocking" privileges. So, for example a local user that does not have "Allow Local Lock" privilege but has "Allow forced unlock (Global and Local)" privilege would still be able to globally and locally unlock the case on Global unlock.

When a user performs a global unlock for a case that has pending local lock (for a Local PRPT case), a warning message is displayed.

When a user performs global unlock for a case that has pending local lock (for a Local PRPT case):

If the value of Allow Global Unlock on Pending Local Lock is set to Yes, a warning message is displayed. If the user selects No, the case shall NOT be unlocked. If the user selected Yes, further checks on reports explained above are implemented.

If the value of Allow Global Unlock on Pending Local Lock is set to No, the case shall NOT be unlocked and an error message is displayed.

If the case has both local lock pending and reports scheduled, the pending local lock check shall take precedence over the pending report generation check.

This functionality is applicable for case unlocking done from any place via the application's UI including Case Form, LAM, E2B, Incoming Review, etc.

This feature is NOT applicable to End of Study Unblinding (EOSU).

Local Report icon in Screens

Setting the Focus for a Follow-up Event

After unlocking a case, the system sets the focus for significant/non-significant follow-up events as follows:

When you click the Significant F/U button on the Case Unlock dialog, the system automatically displays the case General tab, checks the Significant check box for both drugs and devices (if enabled by the profile switch), and sets the focus on the Follow-up Received Date.

Screen: Argus > Case Actions > Open > (Select a Case) > General Tab > General Information Section > Follow-ups sub-section (middle of screen).
- The system checks to determine whether the Significant check box is checked.
- The system sets the focus on the Follow-up Received Date.
When a case is unlocked and you select the Non-Significant F/U button from the case unlock pop-up dialog, the system automatically displays the case General tab and sets focus on the Follow-up Received Date.

Argus > Case Actions > Open > (Select a Case) > General Tab > General Information Section > Follow-ups sub-section (middle of screen)
- The Significant check box is not checked.
- Focus is on the Follow-up-Received Date.
- You can add multiple follow-ups.
  
  Argus > Case Actions > Open > (Select a Case) > General Tab > General Information Section > Follow-ups sub-section (middle of screen)
  - If you add a single follow-up, the Add button remains available for the user to add additional follow-ups.
  - Currently, the Add button disappears after the user adds a single follow-up. The user must save, close and reopen the case before he/she can add an additional follow-up.
- A hyperlink in the follow-ups section enables you to open the link in a different dialog box.

Additional Information Tab

The Additional Information tab enables you to attach notes and other items to the case. For example, you could attach a fax message that came in as part of the case and needs to be scanned and attached or an electronic file received by e-mail. It also enables you to set up cross-references to other cases such as links between cases referring to mothers and children. The total number of attachments and references attached to a case display in the header.

The following is an illustration of the Additional Information tab.

Surrounding text describes additionalinfotab.gif.

When using the Additional Information tab, be aware of the following:

The system shrinks the main widow up to 60% and opens the attachments from the Notes and Attachments dialog in a new browser window.
The system opens any hyperlinks that appear on the Additional Info tab in a new Internet Explorer window if the selected reference is HTTP/URL Reference.
When you click the hyperlink and a reference case is present, the system opens a case number irrespective of the selected reference type when you clicked the hyperlink.
If no sites are defined for the attachments classification, the system permits all users to view the attachments on the Additional Info tab.
The system only permits users who belong to the site defined on the attachment classifications to view the attachments.
The system filters the attachment classifications based on the sites a user has permission to access.
The Case Form/Case Listing reports printout hides the row.
The system permits Workflow Enterprise to view all attachments across all sites

Additional Info Tab Fields and Field Descriptions

The following table lists and describes the fields on the Additional Info tab.

Field/Control Name	Description
Notes and Attachments
Notes and Attachments	This section of Additional Info tab provides an option to sort on the column headers (similar to Activities tab's Action Items sorting feature) to sort the records based on the fields in Notes and Attachment section.
Classification	Select a classification that describes the attachment. The Administrator can adjust this list. Refer to the Oracle Argus Interchange User's Guide for details about Attachment Classification usage in sending attachments in electronic reports.
Date	The current date is automatically entered in this field. You can also enter a date manually.
Incl. Reg. Sub	Select this checkbox to merge PDF attachments within the case form. The Incl. Reg. checkbox identifies the attachments to be included as an appendix to the Expedited Reports. On selecting this checkbox, the Expedited Reports - CIOMS I, CIOMS I (Local), US FDA MedWatch 3500 Drug and 3500 A Device print an appendix page before each attachment. This is added to the case, and marked as Inc. Reg. Sub checked. Note: The checkbox is available only if a PDF is selected as an attachment.
Literature Reference	Select the Literature that is related to the attachment. Attachments that have Literature reference are transmitted as in-line attachments for the data element C.4.r.2 in E2B(R3) report.
Keywords	Enter keywords related to the case or click Select.
Description	Enter a description of the attachment.
Attach File	Inserts a file attachment into the case. Maximum file size is 4 GB.
Add	Inserts a row for an additional attachment.
Delete	Deletes the selected row.
Attach Documentum Link	This option is visible only if Documentum is available. Click Searching for Documentum to search for and attach Documentum.
References Type	Select a reference type from the list, for example, a parent-child link. The Administrator can adjust this list.
ID #	Enter the case number of the case that is to be referenced. Note: Click Select to search for the case that is to be referenced. You can also use this field to record the reference number for external cases.
Notes	Notes can be entered here for reference.
Select	Opens the Case Selection dialog for the selected ID.
Add	Inserts a row for an additional attachment.

Field	Description
Classification	Select a classification that describes the attachment. The Administrator can adjust this list. Refer to the Oracle Argus Interchange User's Guide for details about Attachment Classification usage in sending attachments in electronic reports.
Keywords	On clicking this column header for the first time, records are sorted in the ascending order (alphabetically) of the "Keywords".
Date	On clicking this column header for the first time, records are sorted in the ascending order (chronologically) of the "Date".
Description	On clicking this column header for the first time, records are sorted in the ascending order (alphabetically) of the "Description".

It is possible to send different Case Form attachments to different agencies, based on the 'Attachment classification' specified to the Receiving Agency in Reporting Destination Codelist in Argus Console. Refer to the Argus Console Guide for details.
After the records in Notes and Attachments are sorted, if the following options are invoked without closing the case, sort order is respected in these modules (similar to Activities 'Action Items sorting feature):
- Case Form Print
- Medical Review
- Copied Case

Searching for Documentum Links

To search for Documentum links

Click the Attach Documentum Link button to open the Documentum Lookup screen.
Enter the desired search criteria as per Type Name, Attribute Name and Search String, and click Search.
Select the desired link from the row displaying the search results.
Click Select to select the link from the list.

Attaching Files to a Case

You can attach from 1 to 99 files to a case.

To attach files to a case

In the Notes and Attachments section of the Additional Info tab, click Attach File to open the Attachment dialog box.

Click Browse to locate a file attachment.
Select the file and click OK.

Note:

To view an attachment, click the icon associated with the attachment.

Entering Keywords

You can associate keywords with a case in the Notes and Attachments section.

To attach keywords to a case

Go to the Notes and Attachments section and click Select.
When the system opens the Attachment Keywords dialog box:
- Select a keyword from the Select a keyword to add to the list drop-down list.
- The system displays the selected keywords in the Keywords field.
Click OK

Attaching References to a Case

To add a reference to a case

Locate the References section and click Select.
When the system opens the Case Search Criteria dialog box, enter the appropriate search parameters and click Search.
When the system displays the search results in the Total Number of Rows section, select the desired search criteria from the list and click Select to view details about the selected case.

Regulatory Reports Tab

The Regulatory Reports tab enables you to:

View all scheduled reports
Schedule new reports

When a new case is created, there are no reports associated with it. As data is entered and the case is saved, the regulatory report scheduling algorithm determines which reports, if any, will be required for that case.

The reports determined to be necessary appear in the Regulatory Reports tab. You can manually schedule reports via the Reports menu or by clicking the Regulatory Reports Tab. You can also add comments to the existing reports. The comment section can also be updated to enter the notes for the report even after the report has been submitted.

The following is an illustration of the Regulatory Reports tab.

Surrounding text describes regulatoryreportstab.gif.

General Usage Information

When using the Regulatory Reports tab, be aware of the following:

The case submission date must be on or after the initial receipt date for the case. If the submission date is before the initial receipt date, the system displays the following message:

Please enter the Submitted Date greater than the Initial Receipt Date of the Case
The system displays the time component for the date generated on the Case Form|Regulatory Reports tab using the IE offset of the client machine for the display.
The system displays the time component for the date generated on the Report Details using the IE offset of the client machine for the display.
When you manually schedule an expedited report, the system places the word, Manual, in the Notes field along with the current notes information.
When you manually schedule a report, the system enables you to check "Blind Product Study" on the Schedule New Expedited Report dialog box to blind the study products if they are in the case.

Regulatory Report Tab Fields and Field Descriptions

The following table lists and describes the fields on the Regulatory Reports tab.

Field/Control Name	Description
Status	The notification log provides a list of reports which have been scheduled, generated, or submitted. The following report status are available indicated by the icons in the regulatory reports tab: Report has been routed and approved by a user. Report has been routed and disapproved by a user. Report has been scheduled but not saved. Report has been scheduled and saved. Report has been scheduled and generated. Report has been scheduled/generated and it is past its due date of submission. Report has been scheduled/generated and submitted. Report has been marked as submission not required by a user.
Seq	Displays the sequence (Initial, Follow-up, etc.)
Destination	Displays regulatory authority to which the report is to be submitted.
Report Type	Displays the type of regulatory report like US IND Summary, BfARM Form 643, etc.
License Type	Displays license information.
License #	Displays the license number.
Generated	Displays the date when the regulatory report was generated (if applicable). The system date on which it is generated is used as the default value.
Local Comment	Displays a local comment, if it exists.
Submitted	Displays the date the regulatory report was submitted (if applicable). The system date on which it is generated is used as the default value. This date does not initially appear on the Case Form when submitted. It is displayed when the case is re-opened.
Notes	Displays notes entered when the report was created.
Due	Displays the date the regulatory report is due for submission to the regulatory authority (if applicable). This field is auto-calculated based on the initial receipt date or on the basis of the most recent significant follow-up date. It can also be specified manually by entering the date in the Due Date section.
Responsible	Displays the name of the user responsible for the report.
Auto Schedule button	Initiates Auto-Scheduling of expedited reports according to the configuration for this feature, for example, Always, Significant, Manual, or None.
Schedule Local Reports Only	Allows you to schedule only local reports.
Auto Schedule Device button	Schedules regulatory reports, using the Device rules.
Schedule New Report button	Schedules a new expedited report.
Auto Schedule Later	This item appears if the system is configured for auto-schedule of expedited reports using Argus Safety Service. Select this check box when the system is about to run the auto-scheduling against this case after the case is locked.
Auto Schedule Device Later	Select this check box to run the auto-scheduling for only devices.

Grouping Regulatory Reports

You can group reports by selecting the appropriate grouping structure from the Organized by drop-down list. You can group reports as follows:

Report Type/Submit Category/Reporting Destination
Report Type/Reporting Destination
Report Type/Reporting Group

The numbers in parentheses next to each folder indicate the number of reports in the folder.

The following are definitions of the terms used in the reporting structure.

Report Type -- Can be either Expedited or Periodic reports. The system generates a folder for each type.
Reporting Destination contains all defined code list items for Reporting Destinations that have at least one report scheduled within the case.

If no reports are scheduled for a defined reporting destination, no folder will be created for this destination. All the folders which are the reporting destinations under each folder are sorted alphabetically.

Pending Reports -- Reports that have not been submitted or are marked as non-submitted.
Submitted Reports --All submitted reports.
Marked as Non-Submit --Reports that have not been submitted.
Reporting Group -- Contains all user groups assigned to the scheduled expedited or scheduled in the case

Grouping by Report Type/Submit Category/Reporting Destination

The Expedited folder contains the following:

Pending Reports by Destination
Submitted Reports by Destination
Non-Submitted Reports by Destination

The Periodic folder contains single case report forms (MedWatch, VAERS or CIOMS) that were generated as part of a Periodic Report.

Pending Reports by Destination
Submitted Reports by Destination
Non-Submitted Reports by Destination

Grouping by Report Type/Reporting Destination

The Expedited folder contains a sub-folder for reporting destinations that have at least one scheduled report.

The Periodic folder contains the single case report form (MedWatch, VAERS or CIOMS) generated as part of a Periodic Report are listed in the Periodic section. If no report was generated, the system does not create sub-folders.

Grouping by Report Type/Reporting Group

The Expedited and Periodic folders contain sub-folders for each group that has generated a report. If a group has not generated a report, the system does not create a sub-folder.

X	Is the revision number of the last case
YYYY	Is the date the case was locked
MMMM	Is the time the case was locked in 24-hour format.

XXXX	Is the current case number
YYYY	Is the current letter numbering format (i.e., date and time the letter was generated)