5 Case Form

You can enter case-specific information and log preliminary information about the cases.

  • The maximum number of Products and Events is 200 per case.

  • You can enter a hyperlink (such as http://www.oracle.com and https://www.oracle.com) in the Field Label Help for the Case Form fields.

  • The WHO Drug browser displays the WHO Drug Version on the browser dialog box. The browser dialog box is configured in System Configuration | Case Form Configuration.

  • You can enter decimal numbers with up to three (3) decimal places in the UDF Number fields on all tabs.

  • 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 has only an OK or Cancel button have a Clipboard button that enables you to copy the message content to the clipboard for later use.

To access the Case Form

  1. Search for an existing case.

  2. From the search result, select the case number, and click the case number link.

    The Case Form with information about the case appears.

5.1 Case Form Features

5.1.1 Initial Case Entry—BookIn Dialog Box

  • You can enter the attachment classifications and their descriptions on the Initial Case entry dialog box.

  • The values entered in the Classifications and Description fields are transferred after the cases have been booked.

  • When you 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, a warning message appears.

  • Right-click on the row, and select one of the following:

    • View Case Summary

    • Print Medical Summary—Displays the Medical Summary report PDF. If you do not have access to the Medical Review dialog box, the Medical Summary Report is hidden.

    • Print—Launches the Case Form print dialog box. If you do not have access to the Case Form print dialog box, the Print Case option is hidden.

5.1.2 Argus Safety Case Form User Preferences

You 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, you directed to the 8th Reporter as 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 user preferences are reset.

Quick Navigation

Each page displays the navigation flow to access the page.

Shortcut Key Output
CTRL+SHIFT+# Directs to the tab indicated by the # entered. (1=General tab, 2=Patient tab, etc.)
ALT+SHIFT+# Directs 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.

5.2 General Tab

The General tab captures the case information in categorized sections for category-specific information. It also enables you to enter or view information such as type of report, literature information, and so forth.

  • If a priority has not been assigned to a case, the Case Priority field is hidden.

  • If a case owner has been assigned to the case, the name of the case owner appears at the top of the Case form.

5.2.1 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 value is displayed in red with the time displayed as a negative value. Only archived, locked cases do not display the dynamic workflow indicator.

5.2.2 General Information

5.2.2.1 General Information—Field Descriptions

Field/Control Name Description
Report Type Select a report type that determines availability of fields relating to clinical studies and literature references.

The Clinical Study reports prompts for information relating to the study, and literature-based reports enable 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.

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 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 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

  • Central Received Date

Click on the header to sort in ascending or descending order. By default, the sorting is in descending order of the Follow-up Received Date.
Follow-up Received Date To enter the date on which amendment or follow-up information was received by your company, click Add.

You can select whether the case has significant follow-up information by confirming the message: Is this follow-up significant?.

When sorting on follow-ups, by default, the dates are sorted in descending order.
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 Check this checkbox if the follow-up is significant.
Data Clean up Check this 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 Specify if the case was updated without adding any new information.

This checkbox is enabled irrespective of whether the Significant checkbox is checked.
Amendment/Follow-up Justification Select a pre-defined justification for Amendment or Follow-up.

Click the icon to view the standard justifications dialog box. The justification entered in the Amendment field is also populated in this field.

You can select a pre-defined justification from this dialog box or enter a new justification.
Case Requires Follow-up Check this checkbox if the case requires follow-up information.
Classification Select up to 50 case classifications used to categorize a case.

To enter additional case classifications, click Add.

When the Classifications field is hidden, the classification section is hidden on the Case Form

5.2.3 Study Information

To enter pre-defined study information:

  1. To choose from the available list of study information, click Select.

  2. In the Clinical Trial Selection dialog box, enter Project, Study, and Center information.

    The Clinical Trial Selection dialog box allows you to select a clinical trial from the list configured by the administrator.

  3. Click Search.

    Tip:

    To broaden the search results, enter as little information as possible. Select the required clinical study and study center, and click Select.

  4. Choose the 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.

5.2.3.1 Study Information—Field Descriptions

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 center ID from the list.
Study Phase Enter the Study Phase for the configured study.

This field is pre-populated if you select a Study with an already-configured Study Phase.
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 The status is auto-populated based on the type of study.

You need special access rights to use any of the Broken By entries.

Note: The Unblind Case dialog box 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.
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 Auto-populates 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 box 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 box when blinded status is changed to 'Broken by Sponsor' whereas it is editable when the blinded status is changed to 'Broken by Investigator'.

5.2.4 Reporter Information

Enter the information about the person providing the case-related information.

  • The Reporter Rearrangement dialog box displays 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 box.

  • To view all the Reporters, click the Quick Launch icon.

  • To view the details of the selected Reporter tab, click a Reporter Name.

  • To add a new reporter, click the New tab. You can add a maximum of 100 reporters.

  • The Primary Reporter is identified by the Reporter icon on the Reporter Information tab.

5.2.4.1 Adding Reporter Information

  1. In the Reporter Information section, click Select.

  2. In the Reporter Lookup dialog box, enter the search criteria, and click Search.

    • All filter criteria you have entered on the Reporter Look Up dialog box are saved as user preferences while it populates the reporter information on the General tab.

      • If you have reporter information in the case, the information appears in the Reporter Lookup dialog box and search is performed.

      • After performing the search the search criteria is retained as user preferences. The next time you perform a search, these preferences appears.

      • When you log out, the user preferences are retained and are available the next time you log in.

      • To clear all the values in the filter elements, click Clear.

    Tip:

    You can choose to search either by Search Cases or by Search List Maintenance.

  3. From the search results, select the reporter information, and click Select.

    The selected, pre-defined information is added to the fields.

5.2.4.2 Reporter Information—Field Descriptions

Field/Control Name Description
Reporter Notes Click this button to enter free text notes relating to this reporter.

This field supports multiple language entry. Click on a flag, select the language tab, and enter information.
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 box. This field also allows to manually enter or update the 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 or linked to each other as per Console Institution code list.
Protect Confidentiality If this checkbox is checked, the name and address of the reporter do not appear on regulatory reports and the reporter's information displays "NAME AND ADDRESS WITHHELD".

The 'MSK' null flavor appears 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 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 checkbox is checked 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.
Reporter ID If known, enter the Reporter ID. This completes the Case Form reporter fields.
Reporter Type, Report Media, and Intermediary These lists are maintained by the administrator.
(New) Tab Creates details for a new reporter.

5.2.5 Literature Information Section

You can enter a literature reference for a case manually or you can enter pre-defined literature information.

To enter pre-defined literature information

  1. From the list of available literature, click Select.

  2. In the Literature Reference dialog box, select the a reference in the list, and click Select.

    The details of the selected literature information are added to each field in Literature Information.

5.3 Patient Tab

You can enter patient information such as the patient's past medical history and current conditions, and laboratory tests and test results.

5.3.1 Patient Information

5.3.1.1 Entering Current Medical Status

  1. In the Case Form > Patient tab, click Current Medical Status.

  2. From the items in the form, select the options that apply to the patient.

    If you don't know whether a particular condition applies for the patient, select Unk.

  3. To save the current medical status, click OK.

5.3.1.2 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.

To copy the reporter information, click Patient Info From Reporter.

5.3.1.3 Patient Information—Field Descriptions

Field/Control Name Description
Child only Case If this checkbox is checked, then the pregnancy [Detail] button is accessible from the Parent information tab only and no longer through the Patient tab directly.
Current Medical Status Captures details about the history and the current condition of the patient from the dialog box.

The items that appear in the Current Medical Status dialog box are mapped to the fields for the German BfArM tab on the Analysis tab. Changing the values on the BfArM tab does not affect these items.
Name

(Title, First Name, MI, Last Name)

 During book-in, the patient name is transferred 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.
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 box.
Protect Confidentiality If this checkbox is checked, 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 'MSK' null flavor appears 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 box.
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 box.

Patient Notes

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

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

graph2 Icon is displayed when there is no data in Patient Notes and NF data.

graph3 Icon is displayed when there is data in Patient Notes or NF data.

5.3.2 Patient Details

Enter patient information, including pregnancy data.

Table 5-1 Patient Details—Field Descriptions

Field Description

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: You cannot select the same Race more than once.

5.3.2.1 Entering Pregnancy Information

  1. From the Pregnant drop-down list, select Yes.

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

    The Pregnancy Information section appears.

  2. Enter the available pregnancy information in the form.

  3. Click OK.

  4. In the Neonate Information section:

    • To delete neonate information, right-click the neonate, and click Delete.

    • The changes are tracked to the neonate information in the audit log.

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

Field/Control Name Description
Gestation Period Enter the gestation period when the reaction or event was observed in the foetus. Select a unit for the gestation period from the accompanying drop-down list.
Number of Fetus Enter data for a baby who is born to the patient.

To make an additional entry, click New.
Prospective/Retrospective Select if the information was Prospective or Retrospective.

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.

5.3.3 Event Death Details

Enter information about the death of a patient.

5.3.3.1 Event Death Details—Field Descriptions

Field/Control Name Description
Autopsy Done? If Autopsy Done is set to No or Unknown, the Autopsy Results Available is shown as No.
Autopsy Results Available? The Autopsy Results Available? field is enabled only if the Autopsy Done? field is marked as Yes.

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: You can add multiple records, up to 50 entries.
Delete Deletes a highlighted row.

5.3.4 Other Relevant History

Enter information related to past drugs administered on Patient, and Current Medical condition of the patient.

To copy the Other Relevant History rows, select the row, and click Copy.

5.3.4.1 Other Relevant History—Field Descriptions

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.
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 a test is 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 Stop date is cleared and disabled.
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 ’Medical History Episode' in the Condition Type codelist.
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.
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.
Product Name Parts Information Displays the Product Name Part information. Enabled only for condition type with Patient Other Relevant Therapy being set.
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 box appears.

In either mode, click Encode and modify the encoding. If the condition type is historical drug, the encoding will be done with WHO drugs.
Product Identifier Type/ Product Identifier Version/ Notes 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.

Displays the Date or Version of the Product Identifier. Enabled only for condition type with Patient Other Relevant Therapy being set.
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 and Reaction PT 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.

5.3.5 Lab Data

Enter data about lab test and test results. The maximum number of lab test data on the Case Form is 1500.

  1. To enter a Lab Test Name:

    1. Click Add Test.

    2. Enter the description, and click Search.

    3. From the search result, select a name.

  2. To select a Lab Test Group, click Select.

    A list of lab test that matched the selected group appears.

    If lab test data is already in the case form, the lab test group is appended after the last lab test.

  3. To add more rows of Lab Test Data, right-click on an empty cell, and click Add.

  4. To copy a Lab Test Data, right-click the row to be copied, and click Copy.

  5. To delete a Lab Test Data, right-click the row to be deleted, and click Delete.

  6. To arrange entries in a specific order, click the Order icons.

  7. You can sort Lab data 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.

  8. To view the hierarchy of the Event Term, click the view icon.

  9. To view Notes in a Zoom dialog box, click the view icon.

  10. To arrange the Lab Test Data, click the arrow button to move data to left or right.

    This is available only when the Lab Test is entered for the same date.

5.3.5.1 Lab Data—Field Descriptions

Field/Control Name Description
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.
Result/Units Enter the test result, including units, and select a term to describe the qualitative assessment of the results. The administrator can modify the list of possible assessments.

If test results cannot be expressed in Result/Units or Assessment, enter the data in Notes field.

You must enter Lab test result by using Results/Unit, Assessment or Notes fields, and not in all the fields. Regulatory agencies may send rejection for ICSR if data is sent in all formats.
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.

5.3.6 Relevant Tests

Enter additional information about any relevant tests, such as toxicology.

5.3.7 Parent Information

The Parent Information tab is similar to the Patient tab.

However, in the Other Relevant History section, the Family history, Age, and Units fields are unavailable.

5.4 Products Tab

Enter and view details for products and dosage regimens. This tab contains the name of the drug that has been entered here. For Blinded Studies, the Blinded Product Name field appears in the tab.

If you do not have access to view unblinded information on the Case Form, some of the fields are hidden.

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).

Based 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.

5.4.1 Searching for Products

Product Browser Search

  1. In the Products tab, click Select.

    The Product Browser dialog box appears.

  2. Click the displayed entities.

    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.

  3. Search for Products based on the following criteria:

    • Ingredient

    • Family

    • Product Name

    • Trade Name—Searches the License Trade Name

  4. To select all the search criteria, select the Full Search checkbox, and click Select.

  5. Select a product from the search result.

  6. To remove the entered search criteria, click Clear.

WHO Drug Browser Search

  1. To open the WHO Drug Coding dialog box, click Encode.

  2. From the Case Form Configuration dialog box where the Dictionaries are selected for encoding, select either the WHO Drug B format or the WHO Drug C format.

  3. Enter the search criteria, and click Search.

    You can search a product based on:

    • Trade Name

    • 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.

      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

  4. To copy the selected drug to the Product tab, click Select.

  5. To close the selection dialog box without making any updates to the Product tab, click Cancel.

  6. To perform a full search from the WHO Drug browser, select Full Search.

    • By default, a like search is performed (e.g., CUREALL%)

    • You can use the percent (%) sign to perform wildcard searches

    • If you click Full Search, the a full search is performed (e.g., %CUREALL%)

  7. You can also search for drug formulation and country. This option is available only if you select the WHO Drug C format.

  8. To clear the search criteria you entered, click Clear.

  9. You can sort the results on all the fields.

5.4.2 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 seconds entered in the form are interpreted in the following formats, where:

    # is a number from 0 to 9

    #s—changes the format to # sec.

    # s—changes the format to # sec.

    # sxx

    where:

    x is other letters—that 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.

5.4.3 Drug Tab

5.4.3.1 Product Information—Field Descriptions

This section enables you to enter information about the drug being used for the case.

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 box.

If only one product is found, this information is entered without showing the dialog box. 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 box. 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 box.

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 a 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 based on the selected company product.

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 Displays the type of Product Identifier such as MPID, PhPID, and so on.
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. The WHO Drug code used to identify the drug.

Note: This ID is populated only if a WHO-drug is selected.
Formulation Select the formulation of the product. The form in which the drug was administered (liquid, tablet, capsule, and so on.)

Note: This field is entered based on the product. Contact your administrator to adjust this list.
Drug Authorization Country Enter the company drug code.

Note: This name is entered based on 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 Indicates the amount of the drug that was administered.

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 based on the chosen product. The concentration cannot be modified for a Study drug.
Interaction? Indicates whether the case involves a drug interaction.
Contraindicated? Indicates whether the drug was administered contrary to its indication.
Drug Not Administered Check this checkbox if no drug was administered on the patient.
Substance Information  
Substance Name Displays the Ingredient's name.
Strength The Strength of the substance used in the Product.
Units The drug unit (such as mg, tsp, and so on).

5.4.3.2 The Product Indication

Enter information about the indicator of the adverse event, like:

  • Reported Indication—Reported reaction

  • Coded Indication—Code for the reaction

Both the values could be the different or same.

Table 5-2 Product Indication—Field Description

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. 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 box.

Coded Indication

This field is populated with the encoded term when you enter 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.

To view the complete MEDDRA hierarchy for the encoded term, click the Encoding Status icon.

Add

Adds a new Indication row.

Only two indications are visible at a time

Delete

Click this button to delete the selected Indication row.

5.4.3.3 Entering Quality Control Information

To enter quality control information, click Quality Control.

Quality Control Dialog Box—Field Descriptions

Field Description
Quality Control Safety Date Enter the Quality Control department reference number for the analysis.
Quality Control Cross Reference Enter the Quality Control department reference number for the analysis.
# CID Number Control Identification Number
PCID Number Product Control Identification Number
Lot Number If the Lot Number entered is incorrect, a Lot Number Lookup dialog box is displayed, that allows you to select from the existing lot numbers.
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.

5.4.3.4 Dosage Regimens—Field Descriptions

Field/Control Name Description
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 from the Event Onset Date and the most recent Stop Date or the most recent Start Date.
Ongoing Select this checkbox if the drug treatment is ongoing.

The Stop Date, Duration of Regimen, and Last Dose fields are removed if this checkbox is checked.
Outside Therapeutic Range Check this checkbox if the drug has not been used in accordance with the label or has been used for outside the Therapeutic Range.

Contact your administrator for further company-specific information on the use of this field.
Duration of Regimen This value is calculated 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: Contact your administrator to 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 Description This value is entered by using the values from Dose, Dose Units, and Frequency. If necessary, you can change this value.

If Dose, Units, or Frequency information is changed, this value will be recalculated.
Daily Dosage This value is calculated based 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.
Regimen Dosage This value is calculated based 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 based on the Daily Dose Units.
Accidental Exposure Select the type of Accidental Exposure from the list. A non-modifiable list of items is provided for this list.
Pack Units Select the package presentation information of the product.

Contact you administrator to adjust this list.
(New) Tab Click this tab to create a new dosage regimen entry.

5.4.3.5 Product Details—Field Descriptions

Field/Control Name Description
First Dose The earliest regimen start date.
Last Dose The latest regimen stop date.
Duration of Administration Calculated automatically if full dates are available for the first and last doses.
Total Dosage Calculated 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 a term.

If you select Dose Increased or No change, the dechallenge and rechallenge fields are disabled.

Contact your administrator to adjust this list.
Dechallenge Results Indicates the drug stopped for the purpose of determining if it was the drug that caused the adverse event.
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 a response from the list.
Rechallenge Results Make a selection based on whether the drug was taken again.

If Pos or Neg or UNK is selected for the Rechallenge field, the following fields are enabled:

  • Rechallenge Start Date/Time

  • Rechallenge Stop Date/Time

  • Rechallenge Outcome
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 Check if the patient abused the product (For example: Painkillers taken without pain).
Batch and lot tested and found within specifications Check if the batch and lot was found to be within specifications, after being tested.
Batch and lot tested and found not within specifications Check if the batch and lot was not found to be within specifications, after being tested.
Tampering Check if the product appeared to have been tampered with before it was used.

5.4.3.6 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

  1. Right-click on any suspect product in the case.

  2. To mark the current product as a study drug, select Make Study Drug.

Make sure:

  • The drug type is disabled to make the product a Concomitant or Treatment option.

  • Study Drug is a read-only field that contains the product name selected by you.

  • For non-configured studies in the case, the following message appears for all study drugs in the case:

    Drug Not Administered.

5.4.4 The Device Tab

5.4.4.1 Product Information—Field Descriptions

Field/Control Name Description
M/W Info The MW Info dialog box 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 a checkbox that describe the nature of the follow-up (supplemental) report:

    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. checkbox 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 checkbox 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
 
  • Patient Codes—To display the 'FDA Codes' dialog box and to select the Patient codes, click Select.

  • Device Codes: To display the 'FDA Codes' dialog box and to select the Device codes, click Select.

  • Evaluation Codes Information—To enter the applicable codes from the categories listed, click Select.

    Follow the instructions in the dialog box 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 a 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—Check the checkbox (if applicable) and enter any additional information, evaluation, or clarification of data presented in previous sections.

  • Corrected Data—Check if the data is corrected.
EU / CA Device The EU/CA Device dialog box 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.

  • 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).

  • Remedial Action by HC Facility: Enter the remedial action taken by the Health care facility.

  • Update to Initial Report (Follow-up Report): Check if the Follow-up report must be updated to an Initial report.

  • Availability of Device: Select whether the device was Destroyed, Returned to Manufacturer/Importer, or Neither.

  • 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.

  • Marketed Device Variant/Subset: Enter the value for device variant or subset.

    The valid values are:

    0 – Model

    1 – Software

    2 – Other Variant

    3 – Lot/Batch

5.4.4.2 Entering Quality Control Information

See Section 5.4.3.3, "Entering Quality Control Information".

5.4.4.3 Product Indication

See Section 5.4.3.2, "The Product Indication".

5.4.4.4 Product Delivered by Device—Field Descriptions

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.

5.4.4.5 Device Component Information—Field Descriptions

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.

5.4.4.6 Device Information—Field Descriptions

Field/Control Name Description
Product Information  
Catalog # Under Catalog#, enter the exact catalog number as it appears in the manufacturer's catalog, device labeling, or accompanying packaging.
UDI System The UDI System captures the unique identification type of the given device.

The valid values are:

GS1 – Global Standards 1

HIBCC - Health Industry Business Communications Council

ICCBBA - The International Council for Commonality in Blood Banking Automation
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).

Data is entered in such a way to handle the UDI Device identifier and UDI Production Identifier fields.
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.
Malfunction Type Make a selection to indicate the type of reportable event. For an event associated with a malfunction, the FDA refers to applicable sections in 21 CFR Part 803 reporting guidelines.
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.
CE Marked Select whether the device is CE Marked or not. This information is preloaded from License information for a case booked manually, through E2B or LAM, and can be modified as needed.
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.
Incident Information This section captures the incident details. It contains the following fields and supports multi record entry. The Event Type Level codes are cascading, that is, Event Level 2 depends on 1.

Event Type Level 1

Event Type Level 2

Manufacturer Event Type Level 3

Event Type Level 3 Description
Manufacturers Final Investigation Results This section captures the investigation details. It contains the following fields and supports multi record entry. The Evaluation Type Level codes are cascading, that is, Evaluation Level 2 depends on 1.

Evaluation Type Level 1

Evaluation Type Level 2

Manufacturer Evaluation Type Level 3

Manufacturer Evaluation Type Level 3 Description

EU/CA Device Dialog Box—Field Descriptions

Field/Control 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 Checkbox
Other 15 characters Alphanumeric
Update to Initial Report (Follow-up Report) N/A Checkbox
Final Report N/A Checkbox

When you select the EU/CA Device option, the fields on the Case form are printed. A track of the fields and any updates are maintained in the audit log.

5.4.5 Vaccine Tab

5.4.5.1 Product Details

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 Section 5.4.3.5, "Product Details—Field Descriptions".

5.4.5.2 Prior Adverse Events Information

  1. Enter the relevant vaccination information items in the form.

  2. Click OK.

5.4.5.3 Product Information Section—Field Descriptions

Field/Control Name Description
Include in VAERS Block Select the VAERS Form block that this vaccine needs to be printed in.
Suspect/Concomitant/Treatment Make a 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. I

if the study is blinded, the Generic Name is replaced with the Study Name of the product.

This name is entered based on the selected company product.
Formulation Select the formulation of the product. Contact your administrator to adjust this list.

Note: This field is entered based on the product.
Drug Authorization Country Displays the licensed country for the selected 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 based on the selected product. The concentration cannot be modified for a Study drug.
Units Select a concentration unit.

Contact your administrator to 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.

5.4.5.4 Vaccine Administration Form—Field Descriptions

Field/Control Name Description
For VAERS Form-1 Use Only  
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 an item from the list to describe how the vaccine was purchased.
Vaccine Facility Information  
Facility Name Enter the name of the facility where the vaccine was administered.
Country Enter the country of the facility where the responsible physician works.
Facility Type Enter the facility type where the patient was vaccinated.
Facility Military Flag Indicates whether or not the vaccination facility was a Military facility.

5.4.5.5 Vaccine History Section—Field Descriptions

Field/Control Name Description
Route of Admin Enter the route of administration or a short code for the route of administration.

Contact your administrator to adjust this list.
Anatomical Location Select the anatomical location of the vaccination.

Contact your administrator to adjust this list.
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.

5.5 Events Tab

You can enter or view details for adverse events associated with a case using this tab. It has the following sub-tabs:

  • Events tab

  • Event Assessment tab

  • Product-Event Details tab

Events Tab—Field Descriptions

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 to null.

The system uses only complete 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 event onset date, if present.

If the regimen start date is null, the system sets the Last Dose to Onset is to null.

The system uses only complete date entries for regimen start and stop date/time fields to calculate the Last Dose to Onset.

The user can overwrite this field.

  • You can change the listedness for a drug at the individual level.

  • The field labels for the Event Assessment tab can be updated and configured on the Argus Console.

  • If the Death Seriousness criteria on the Event tab are unchecked, the event outcome reverts to empty and is not set to fatal.

  • The MedDRA LLT term selection behavior across the Case Form is 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.

  • The system populates the To be coded value on the MedDRA pop-up window when you check the green checkbox for the MedDRA hierarchy. This applies to the areas where the MedDRA dialog box appears.

  • The Event to Exclude from Report field enables you to identify information to not include in a PMDA Expedited report.

    • When this checkbox is checked, enter a justification for this action in the Reason to Exclude from the Report dialog box.

      The system places a symbol to the right of the field.

    • 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.

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).

5.5.1 Event Tab

The Event information tab lets you encode adverse events, record criteria for event seriousness, and display results of automated assessments that determine whether events are listed in data sheets. It also lists the licenses for the data sheets.

5.5.1.1 Event Information Section

Event Information—Fields Descriptions

Field/Control Name Description
Relationships Click the Relationships button to view the Diagnosis-Event Relationships dialog box. This allows you to group symptoms and signs with diagnoses. This requires at least two events and a diagnosis.
Description as Reported Enter the verbatim term used by the reporter, or patient, to describe the adverse event. As you type, the term is copied under Description to be Coded. Verbatim English translations of foreign languages may also be entered here.
Term Highlighted by Reporter Indicate whether the primary source reporting the event considered it a major concern. If the information was not explicitly provided, the term is not considered a highlighted term. The seriousness of the reaction/event must be based on the ICH E2A criteria.

Selecting Yes does not mark this case as Serious.
Description to be Coded You can modify the verbatim term in this field. For example, the original term can be split, or enhanced with an anatomical location. Contact your system administrator to 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 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.
Duration This field is calculated from the event start and stop dates. You can also enter or modify the duration manually.
Onset Latency This field is calculated from the earliest first dose date of the suspect drug(s) to onset date. You can also enter or modify the duration manually.

Onset Latency = Onset Date - First Dose.
Receipt Date Enter the date on which information about this event was received by your company. In Flexible Aggregate Reporting, this field is used to filter the events that falls out of the reporting period.
Patient Has Prior History? Indicate whether the patient has had a prior history or has suffered from the same event in the past.
Intensity Select the category of severity of the event. Contact your system administrator to adjust this list.
Frequency Select the frequency of the event from the list. Contact your system administrator to adjust this list.
Outcome of Event Select the outcome of the event. Contact your system administrator to adjust this list. If Fatal is selected, Death is selected in the list of seriousness criteria.

If the Death checkbox is subsequently cleared, the outcome still remains fatal.

5.5.1.1.1 Understanding the Diagnosis-Event Relationship

You can group events in a case, and/or associate them with particular diagnoses. Your company may determine these or they may be reported to it. This helps in interpreting and reviewing individual case reports. You can also enable the reporting of diagnoses only, while retaining database records of individual event terms.

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

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

5.5.1.1.2 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.

For example:

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 coincidental, 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 provides a clear clinical picture of the case.

5.5.1.1.3 Using the MedDRA Browser

The MedDRA application searches the term dictionary for a match at the Lower level 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.

5.5.1.1.4 Configuring Regulatory Reporting Rules

The regulatory reporting rules 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.

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

5.5.2 Event Coding Section

The Event Coding section enables you to enter information about the event.

Event Coding Section—Field Descriptions

Field/Control Name Description
System Organ Class (SOC) (Code) Displays the body system or System Organ Class. This item is automatically entered from the event dictionary used and cannot be edited.
High Level Term (Code) Displays the high-level group term when using the MedDRA coding dictionary. This field is not shown when coding with WHO-ART and cannot be edited.
High Level Term (Code) 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 and cannot be edited.
Preferred Term (Code) Displays the preferred term. This item is automatically entered from the event dictionary used and cannot be edited.
Included Term (Code) Displays the lower level term code. This item is entered from the event dictionary used and cannot be edited.

5.5.3 Seriousness Criteria Section

Seriousness Criteria Section—Field Descriptions

Field/Control Name Description
Death Displays the Death Details dialog box

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 box.
Other Check this checkbox to enter explanatory text. You must mandatorily enter text, specifying the Other Seriousness Criteria.

5.5.3.1 Entering Death Details

  1. Check the Death checkbox under Seriousness Criteria.

    The form for Event Death Details appears.

  2. Enter information for the items in the form.

  3. Click OK to save the entered Death Details.

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.

5.5.3.2 Entering Hospitalization Details

To complete the Hospitalization Details form

  1. Check the Hospitalized checkbox under Seriousness Criteria.

    The form for Hospitalization Details appears.

  2. Enter information for the items in the form.

  3. Click OK to save the entered Hospitalization Details.

5.5.3.3 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.

5.5.3.4 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 transfers it to this field.

5.5.4 Event Assessment Tab

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.

5.5.4.1 Event Assessment Tab—User 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 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.

Event Assessment Tab—Fields Descriptions

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 Populated when events are entered in the Products tab and appears as:

  • First Line - Product Name

  • Second Line - Generic Name
Causality as Reported/Source/ Method/ Result Provides the source of causality as reported such as Investigator, Healthcare Professional, and so on.

Provides the method used for causality determination.

Provides the result of the causality assessment.
Causality as Determined/Source/ Method/ Result Provides the source of causality as determined such as Sponsor, MAH, and so on.

Provides the method used for causality determination.

Provides the result of the causality assessment.
Other Causality /Source/ Method/ Result Provides the source of causality from any additional source such as NCA.

Provides the method used for causality determination.

Provides the result of the causality assessment.
Event Populated when events are encoded and appears as:

  • First Line - Event PT (Verbatim)

  • Second Line - LLT
D/S Displays the Diagnosis/Symptom details by D or S.
Seriousness Severity Duration Displays the seriousness, severity, and the duration of the event.
Listedness Indicates whether the system found the event on the datasheet for this product.

5.5.4.2 Event Assessment Tab—Filtering

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

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

5.5.4.3 Product-Event Details Tab

The Product-Event Details tab enables you to capture causality information for a case.

Product-Event Details—Field Descriptions

Field/Control Name Description
Event Populated when events are encoded and appears as:

  • First Line - Event PT (Verbatim)

  • Second Line - LLT
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 This value is calculated based on daily dose and duration.

5.6 Analysis Tab

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

Use this tab to:

  • Make a medical assessment of the case

  • Approve the case for completeness and accuracy

5.6.1 Analysis Tab

5.6.1.1 Case Analysis Section

Use this section to enter narrative information about the adverse event.

Case Analysis—Field Descriptions

Field/Control Name Description
Narrative Click Generate to generate an auto narrative.

Contact your system administrator to configure this feature. 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.
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.

Auto Narrative Templates

To generate or add narrative templates:

  1. Click the button to view the Custom Auto Narrative Templates dialog box.

  2. Select the required Autonarrative from the list.

  3. Click Append to append this Autonarrative to the existing narrative.

  4. Click Append if this is the first narrative being added to the text area.

  5. Click Replace to replace the existing narrative with the selected narrative.

    Note:

    Contact your system administrator to configure allowing modification of the Autonarrative text.

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

Viewing Differences in Case Narratives

You can 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 Analysis 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 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.

5.6.1.2 Case Summary Section

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

Case Summary—Field Descriptions

Field/Control Name Description
Case Serious This list indicates whether the overall adverse event case is serious or non-serious. This assessment is 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 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.
Case Serious Notes A justification for overriding the system determination appears in the Notes area. Click the green dot to revert to the automatic calculation for seriousness or to view the overriding notes.
Causality considered expeditable The system 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.
Causality considered expeditable Notes A justification for overriding the system determination appears in the Notes area. Click the green dot to revert to the automatic calculation 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 displays Unlisted under the Listed column, this value is set to unlisted.
Listedness Determination Notes A justification for overriding the system determination appears in the Notes area. Click the green dot to revert to the automatic calculation or to view the overriding notes.
Case Outcome The value for this field is 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 appears in the Notes area. Click the green dot to revert to the automatic calculation or to view the overriding notes.

5.6.2 The MedWatch Info Tab

The MedWatch Info tab enables you to enter additional details required for the MedWatch 3500A Drug Report.

MedWatch Info—Field Descriptions

The values in the Form section column refer to specific sections of the MedWatch 3500A Drug Report form.

Form Section Field Description
B. Adverse Event or Product Problem 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.

Check both checkboxes if a malfunction or product problem caused a death or serious injury.
C. Suspect Medications (NDC#) Enter the National Drug Code if you have checked the Product Problem checkbox.
F1. Check one 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 the Case Form or the 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.
F6. Date aware of event Enter the date when 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 6 FDA Patient Codes. If the entered code is not present in the FDA Codes list, it is erased.
F11. Report sent to FDA Check this checkbox if a report has been sent to the FDA. If you select it, enter the date when the report was sent to FDA.
F13. Report sent to mfr? Check this checkbox if a report has been sent to the manufacturer. If you select it, enter the date when the report is sent to manufacturer.
G. All Manufacturers -
G3. Report Source Check the Report Source checkboxes as applicable, to match all report sources specified with the Reporter Type.

See the guidelines below this table for checking the checkboxes.
G5. STN# 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.

5.6.2.1 Selecting G3 Report Source Checkboxes—Guidelines

If this condition is true Check the following checkbox
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 checkbox 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

The User Facility and Distributor checkboxes must be checked manually.

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

5.6.3 The BfArM Info Tab

To enter data for the BfArM report

  1. Open the BfArM Info tab.

  2. Select the choices that apply to the patient from the items in the form.

  3. 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 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.

5.6.4 The AFSSaPS Info Tab

Use the AFSSaPS Info tab to enter the imputability assessment information for the suspect product along with the Adverse Events.

AFSSaPS Info—Field Descriptions

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:
~ Check 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.

5.7 Activities Tab

The Activities tab presents detailed information about the Contact Log, Routing Comments, Action Items, and Case Lock/Closure.

5.7.1 Contact Log Section

The Contact Log section of the Activities tab lets you:

  • Track correspondence related to individual cases

  • Display scheduled letters

Contact Log—Field Descriptions

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.

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

Field/Control Name Description
Date The date is 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 box. 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. Contact your system administrator to adjust the information in this list.
Description Enter a brief explanation for the letter, for example, Initial Letter, or the details of a phone conversation.
Group/User Select a group responsible for the Contact Item. From the list below, select a user from the selected group who is responsible for the action. The Contact Item appears in the Worklist for the selected user. If Any is chosen as the group, the Action Item appears in all the users' Worklist. Contact your system administrator to adjust the information in these lists.
Date Sent The date is 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 becomes read-only.

5.7.1.1 Generating Letters

To generate a letter

  1. Select Contact Log from the Activities tab and click New Letter.

    The Custom Letter Templates dialog box opens.

  2. Select the required letter template from the list and click OK to open the letter in a separate window.

  3. Make the necessary changes to the letter text and Save.

  4. 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.

  5. After saving the letter, the system displays it in the Contact Log section of the Activities tab.

  6. The system creates an action item for following-up on this letter in the Action Items section of the Activities tab.

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

Surrounding text describes lettericons.jpg.

  • A letter is only added to a search if the Correspondent checkbox is checked.

  • Contact your system administrator to 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.

  • If the Primary Reporter is marked as a correspondence contact, the system sends auto-scheduled letters 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. You must send or remove letters manually.

  • In addition to auto-scheduling letters, 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.

  • 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 (that is, 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

5.7.1.2 Scheduling Action Items for Letters

When specifying or changing the Date Sent field in a letter, you can schedule an action item.

  • 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

5.7.1.3 Opening a Message Editor

To open a message editor

  1. Click the letter icon to open the message editor.

  2. The system opens the message editor. All fields are editable.

Field/Control Name Description
To Displays the email address specified for the Primary Reporter in the Case Form.
From Displays the email address specified in the Return Email Address in Argus Console > Code Lists > Letter Configuration.
Subject Displays the Case Number and the Description of the Contact log.

5.7.2 Action Items Section

The Action Items section lets you view or enter details of action items for the case and assign responsibilities for actions.

Action Items—Field Descriptions

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 it. They also appear in the Open Action Items report.
Code Select an action item code from the drop-down list. This displays the description of the selected Action Item Code. Contact your system administrator to adjust this list.
Description Selecting an Action Item code automatically enters information into this field. The text can be modified. The Administrator can adjust this list.
Group /Responsibility 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 is responsible for the action. The action item appears in the Worklist for the selected user. If Any is chosen as the group, the action item appears in all the users' Worklist. Contact your system administrator to 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 the Argus Console's Action Type codelist.

5.7.3 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.

To route a case

  1. Select Route from the Activities tab of the Case Form menu to open the Case Routing dialog box.

  2. 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 is selected by default in the Route to Next State field.

  3. From the Route to User drop-down list, select the user or user group to route the case to.

  4. 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—Field Descriptions

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

5.7.3.1 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.

  • 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 sites, all Workflow Managers can see it.

Routing Comments Log and Case Print

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

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. JP is the standard A2 country code for Japan defined in the Argus Console > Countries codelist.

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 Unlocked for JP is added for single unlock operation.

The system records the corresponding routing comments even in scenarios where the system user (for example, AGservice) performed the local lock/unlock action.

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

  1. Click the Select button in the Case Routing dialog box to open the Routing Justification dialog box.

  2. Select the required justification from the justification list displayed under Select a standard justification for this field. The system highlights the selected row.

  3. Click OK.

  4. The system closes the Routing Justification dialog box and displays the selected justification text in the Comments field in the Case Routing dialog box.

  5. Click OK.

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.

5.7.3.2 Returning Cases

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

To return a case to its previous workflow state

  1. Open the case.

  2. Click the Return button in the Activities tab of the Case Form.

  3. When the system opens the Case Routing dialog box, enter your password.

  4. From the Route to User drop-down list, select the user or group the case needs to be returned to.

  5. Enter any routing comments in the Comments field.

  6. Click OK.

5.7.4 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.

When closing a case:

  • 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 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 box on the Worklist.

Case Lock/Close—Field Descriptions

Field/Control Name Description
Case Status Enables you to unlock, lock, or close a case after entering user information.

  • Unlock -- Enables you to unlock a case if you have the 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 permissions. The current date is 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 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 displays 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 must 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 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

To lock a case

  1. In the Case Lock/Close section of the Activities tab, click Lock.

    The system opens the Case Locking dialog box.

  2. Enter your Argus Safety password in the Password field.

  3. Enter any notes in the Notes field.

  4. Click OK.

  5. The system displays the locking notes in the Notes field of the Case Lock/Close section.

To unlock a case from the Locked/Archived state, select the Unlocked value from the Case Status drop-down list. This displays the Archived Case or Case Lock dialog box. 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.

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 window 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, the system checks if the case has any Local Japan report, that is pending generation, and displays a warning message.

If there are no Local Japan reports that are pending generation, the system prompts the user (on Case Local Unlock dialog box) 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.

Lock Status—Descriptions

Lock Status with Icon Description
Global Locked Surrounding text describes glbl.jpg. Denotes a locked case that does not have local reporting needs.
Global Unlocked Surrounding text describes glbl1.jpg. 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 Surrounding text describes glbl2.jpg. 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 Surrounding text describes glbl3.jpg. Denotes a Local PRPT case that is locked global but pending local lock for any local country for the case.

5.7.4.1 Locking a Case

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

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

  • All 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 updates the global value such as Re-arrange, Add, Delete, Up / Down buttons, Relationships, Copy Japanese to English button, Lab data import is not allowed. One exception to this is Case Classification field - the Add and Delete buttons remain available.

  • The Copy English to Japanese button allows the user to copy information from English to Japanese data entry. No global values are updated with the Copy action.

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

  • All the qualifying Global (that is, non-Japan) and Japan Local reports are scheduled.

  • The Global (that is, non-Japan) reports are 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 and English translation may happen before the global lock, which necessitates the Global and Local Lock be done in a single step by the Japanese user.

When a local user (Argus J user) performs a global lock, the system displays the existing Case Locking dialog box but enhances it with an option to perform Local lock additionally for a Local PRPT case.

Note:

This functionality is applicable for global case locking done from any place via the application's UI including Case Form, E2B, Incoming Review, and so on.

This checkbox appears only for a Local PRPT case, when the user has Allow Local Locking 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 performs both the global and the local lock for the case.

5.7.4.2 Unlocking a Case

  1. In the Case Lock/Close section, select Unlocked from the Case Status drop-down list.

  2. 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.

  3. 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 checks if the case has local or global reports in pending generation state (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 (that is, DLP is not enabled for Expedited reporting).

The system checks the value returned by running the SQL (if any) configured in the SQL to prevent case unlock when reports are pending generation common profile switch under Case Processing. If the value returned is 0 or no SQL has been configured, the system allows 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 (that is, the configured SQL returned a value > 0), the case is not unlocked and an error message is displayed.

  • If the Value of Allow forced unlock (Global and Local) is Yes and the Report status (Global or Local) is Pending (that is, the configured SQL returned a value > 0), a warning message is displayed. The case is unlocked using the Locked Case dialog box 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 (that is, the value from SQL check returned 0 or no SQL has been configured), the case is unlocked.

This switch functions independent of the Allow Local Lock and Enable Local unlocking privileges. For example, a local user who does not have the Allow Local Lock privilege but has the Allow forced unlock (Global and Local) privilege can 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 is NOT unlocked. If the user selected Yes, further checks on reports are implemented.

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

  • If the case has both local lock pending and reports scheduled, the pending local lock check takes 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, and so on.

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

5.7.4.3 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:

  1. When you click the Significant F/U button on the Case Unlock dialog box, the system displays the case General tab, checks the Significant checkbox for both drugs and devices (if enabled by the profile switch), and sets the 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 system checks to determine whether the Significant checkbox is checked.

    • The system sets the focus on the Follow-up Received Date.

  2. When a case is unlocked and you select the Non-Significant F/U button from the case unlock pop-up window, the system 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 checkbox 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.

      • The Add button disappears after the user adds a single Follow-up. The user must save, close, and reopen the case before they can add an additional Follow-up.

    • A hyperlink in the Follow-ups section enables you to open the link in a different dialog box.

5.8 Additional Information Tab

The Additional Information tab lets you attach notes and other items to a 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 email. It also lets you 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 appears in the header.

  • 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 Information tab.

  • The system permits Workflow Enterprise to view all attachments across all sites.

Additional Info—Field Descriptions

Field/Control Name Description
Notes and Attachments
Notes and Attachments Lets you sort column headers to sort the records based on the fields in the Notes and Attachment section.
Classification Select a classification that describes the attachment. Contact your system administrator to adjust this list.

Refer to the Oracle Argus Interchange User's Guide for details about Attachment Classification usage in sending attachments in electronic reports.
Incl. Reg. Sub Check this checkbox to merge PDF attachments within the Case Form. The Incl. Reg. checkbox identifies the attachments to be included as an appendix to Expedited reports. On checking 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.

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 inline attachments for the data element C.4.r.2 in the E2B(R3) report.
Attach File Inserts a file attachment into the case. Maximum file size is 4 GB.
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. Contact your system administrator to adjust this list.
ID # Enter the case number of the case that is to be referenced.

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.
Select Opens the Case Selection dialog box for the selected ID.

  • Field Description
    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.

  • You can send different Case Form attachments to different agencies, based on the Attachment classification specified to the Receiving Agency in the Reporting Destination Codelist in the Argus Console. For more information, refer to the Argus Safety Administrator's Guide.

  • After the records in Notes and Attachments are sorted, if the following options are invoked without closing the case, the sort order is respected in these modules:

    • Case Form Print

    • Medical Review

    • Copied Case

5.8.1 Searching for Documentum Links

  1. Click the Attach Documentum Link button to open the Documentum Lookup screen.

  2. Enter the desired search criteria as per Type Name, Attribute Name and Search String, and click Search.

  3. Select the desired link from the row displaying the search results.

  4. Click Select to select the link from the list.

5.8.2 Attaching Files to a Case

5.8.2.1 To attach files to a case

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

  2. Click Browse to locate a file attachment.

  3. Select the file and click OK.

To view an attachment, click the icon associated with the attachment. You can attach from 1 to 99 files to a case.

5.8.3 Entering Keywords

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

To attach keywords to a case

  1. Go to the Notes and Attachments section and click Select.

  2. 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.

  3. Click OK

5.8.4 Attaching References to a Case

  1. Locate the References section and click Select.

  2. When the system opens the Case Search Criteria dialog box, enter the search parameters and click Search.

  3. 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.

5.9 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, are 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 existing reports. The comment section can be updated to enter notes for a report even after it has been submitted.

  • 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 an error message.

  • 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.

Regulatory Report—Field Descriptions

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 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 details of the sequence such as Initial, Initial (A1), F/p #1, and so on.
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, and so on.
Generated Displays the date when the Regulatory report was generated. The system date on which it is generated is used as the default value.
Submitted Displays the date the Regulatory report was submitted. 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.
Due Displays the date the Regulatory report is due for submission to the regulatory authority. 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. This button is displayed only when the common profile switch, Enable separate scheduling of device reporting rules from drugs and vaccines, is set to Yes.
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. Check this checkbox when the system is about to run auto-scheduling against this case after the case is locked.
Auto Schedule Device Later Check this checkbox to run auto-scheduling for devices only. This button is displayed only when the common profile switch, Enable separate scheduling of device reporting rules from drugs and vaccines, is set to Yes.

5.9.1 Grouping Regulatory Reports

You can group reports by selecting the 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 codelist 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 is 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

5.9.1.1 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

5.9.1.2 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 listed in the Periodic section. If no report was generated, the system does not create sub-folders.

5.9.1.3 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.