12 Utilities

This chapter discusses the different utility functions to help you view, change, or retrieve case-related information.

Utilities

To access the Utilities menu, place the cursor over the Utilities menu bar to view the available options.The following utilities are available to you.

• Change Password

• MedDRA Browser

• MedDRA J Browser

• User Login List

• Logs

• E2B

• Argus Reconciliation

• Undelete

• Batch Reports

• Blank Report Forms

• End of Study

• Clear Cache

Change Password

The Change Password functionality allows users to change the password that they use to login to Argus. When you log on to the system for the first time, change the password that has been assigned to you.

Note: LDAP users cannot change their passwords.

To change your password

1. Select Change Password from the Utilities menu.

2. When the system opens the Change Password dialog box:

   • Enter your current password in the Old Password field.

   • Enter your new password in the New Password field.

   • Re-enter your new password in the Confirm Password field to verify it.

   • Click OK to change your password,

3. Your password has been changed.

Be aware of the following:

• If the system has difficulty confirming the password, it presents the Password Confirmation Failure dialog box.

• You cannot re-enter the password you are currently using when the system prompts you to change your password.

• When you update your password, the system displays the system date and time.

MedDRA Browser

Use the Medical Dictionary for Regulatory Activities (MedDRA) to encode diseases, symptoms, signs, and so forth. In Argus Safety, the usage of such a dictionary provides consistency to the assignment of terms for adverse events.

1. Select Utilities --> MedDRA Browser.

2. The system opens the MedDRA Browser screen.

MedDRA J Browser

For all Japanese cases, use the MedDRA J to code all medical terms. The following is an illustration of the MedDRA J browser.

When using the MedDRA browser, be aware of the following:

• The system requires both MedDRA and MedDRA J data files to be loaded in the database.

• The application supports both MedDRA and MedDRA J, but only one can be active at a time.

• If you encode a MedDRA J term in Japanese, the system also encodes the equivalent MedDRA term. and put it in the English MedDRA data field with the corresponding LLT code.

• When you code MedDRA/MedDRA J terms, the coded terms could be non-current in the other language. The system identifies such terms with a special symbol as shown in the following illustration.
  

• After you perform the first coding, you can change the LLT coding in the same PT level only for that language without synchronizing the alternate language MedDRA coding.

• Changing the PT level or above from the MedDRA J browser updates MedDRA MedDRA. Changing the PT level or above from MedDRA updates the MedDRA J coding.

User Login List

The User Login List displays a list of all the current users and their security levels. It also displays a list of all the currently logged in users. The following is an illustration of the User Login List.

Description of the illustration userloginlist.gif

To view the User Login List

1. Select Utilities --> User Login List.

2. The system opens the User Login List screen.

General Usage Information

When using the User Log List, be aware of the following:

• You can click a column heading to sort the displayed records.

• By default, the system displays the User Login List in ascending order based on Login Time.

The following table lists and describes the fields on the User Login List.

Field	Description
Full Name	Displays the full name of the user.
Login Time	Displays the login time.
Workflow Manager	Displays whether the user is a workflow manager or not.
OS User Name	Displays the Operating System user name.
Terminal	Displays the name of the terminal.
Print List	Allows you to print the user login list.

• You can configure the number of cases to display from the Page Size drop-down list in the User Login List dialog box. The Page Size drop-down list contains the following values:

  • 50

  • 100 (default)

  • 250

  • 500

  • 1000

  • 2000

• The system displays the number of cases currently in view and automatically updates the range as defined by the Page Size drop-down list. For example, if the user selects 100, the system separates the rows to display into groups of 100 cases.

• You can go directly to a range of cases by selecting a range from the Displaying Rows drop-down list.

• You can scroll through the User Login List search results in page-by-page increments.

• You can select multiple users or click the All users check box in the header.

• When you select a user and click Reset User, the system resets all selected users in the list.

• The system does not permit you to reset your login.

Logs

Logs are a repository of all the cases in the database, displaying the Activity, Audit Data, User ID, and Date/Time entries. Three (3) types of logs are available in Argus:

• View Audit Log

• LAM Audit Log

• View Error Log

To view a log

1. Select Utilities --> Logs --> <Log Type> to view a log.

2. The system open the selected log type.

View Audit Log

The audit log is a chart that show modifications that have been made to a particular case since the case's inception.

It also shows which user made the changes, the date and time the changes were made, and the old and new field values. Run the AG Service Audit Log update to audit log all the cases.

To view an Audit Log

1. Select Utilities --> Logs --> View Audit Log.

2. The system opens the Audit Log screen.

   
   Description of the illustration auditlog.gif
   
   

Search Conditions Section

The Search Conditions section enables you to enter information about the logs you want to view.

The following table lists and describes the fields in the Search Conditions section.

Field	Description
Category	Select the category for the search criterion. Tip: You can also search for Advanced Conditions in this Application release. The system enables you to Select All to view all updates performed by a user. You can select a category and filter on a specific field elements, and you can view all revisions at the same time by clicking the checkbox near the Revisions column.
Case Number	Enables you to search for logs for a specific case number
Date Range	Select the date range from the given drop-down list. This selection automatically populates the From and To fields.
From	Enter the initial date of the time period to be searched.
To	Enter the end date of the time period to be searched.
User Name	Select the User Name for the search.
Search button	Displays the results of the specified search criteria.

Total Number of Rows Section

The system displays the search results in the Total Number of Rows section.

The following table lists and describes the fields in the Total Number of Rows section.

Field	Description
Action	Displays the Audit Log Details screen
Activity	Displays the status of the activity. Displays whether it has changed or not.
Audit Data	Displays the audit data in the following format: Name of the entity (such as Advanced Condition): deleted or changed (as applicable) in entity (such as Advanced Condition)
User	Displays the last user who made changes to the case.
Date/Time	Displays the last time the case was changed. Note: The time displayed is as per GMT.
Print List button	Prints the list of all the logs.

Audit Log Details Screen

The Audit Log functionality tracks all central coding activities for the code-able event and products.

Audit log for the case has the record of the central coding related changes. These changes display the Username as the associated Central Coding Username concatenated with Central Coding.

Multiple selections can be made to view the details of revisions.

To view the Audit Log Details screen

1. Click the Action icon to view the Audit Log Details screen.

2. 2. Click a row displaying a revision to display the details in the upper portion of the screen.

The following table describes the fields in the Audit Log Details screen.

Field	Description
Total Number of Rows	Displays the total number of rows in the list.
Parent	Displays the parent screen where the change has been made.
Field	Displays the field where the change has been made.
Old Value	Displays the previous value.
New Value	Displays the new, changed value.
Rev	Displays the revision number. The list is sorted in descending order of the revisions that have been made so the latest revision is displayed at the top.
User Name	Displays the name of the last user who made a change.
Revisions Date	Displays the last date when the change was made.
User	Displays the name of the user who last made the revision.

LAM Audit Log

The LAM Audit Log enables you to track changes made while using the LAM module.

To view the LAM Audit Log

1. Select Utilities --> Logs --> LAM Audit Log.

2. The system opens the LAM Audit Log screen.

General Usage Information

• When using the Argus Safety Audit Log, be aware of the following:

• In the Argus Audit Log Options, Category has an <ALL> option that enables viewing of all updates made by a user.

• If you select All, you must select the appropriate User Name from the drop-down to enable the Search button. The system updates the default User Name to the name of the user who is logged in.

• The system identifies the category on the UI.

• The print list displays the Category.

• The system updates the element field label based on the category selected by the user. If you do not enter an element value, the system returns the audit details as is does in the current system.

• You can view All revisions at the same time by selecting the check box near the revisions column. This system displays the entire audit trail for the elements.

Using the Argus Affiliate Audit Log

When using the Argus Affiliate Audit Log be aware of the following:

• You can filter for a specific Affiliate event in the audit log.

• You can view all revisions at the same time by selecting the check box near the revisions column. The system displays the entire Audit trail for the elements.

• You can view all LAM user updates made for Argus Safety cases under the LAM Audit Trial. For example, the action Items which can be closed or local labeling performed by a Affiliate user is visible under the LAM audit trail.

• Central User updates do not display under the LAM audit trail.

• Any user who has access to LAM Audit Log can view All cases associated with that site.

• The audit trail detail print includes only the revisions the selected by the user.

Search Conditions

The Search Conditions section enables you to enter information for retrieving the audit logs you want to view.

The following table lists and describes the fields in the Search Conditions sections.

Field	Description
Local Event Number	Enter the appropriate local event number.
From	Enter the initial date of the time period to be searched.
To	Enter the end date of the time period to be searched.
Search button	Displays the results of the specified search criteria.

Total Number of Rows

The system puts the search results in the Total Number of Rows section.

The following table lists and describes the fields in this section.

Field	Description
Action	Displays the Audit Log Details screen.
Activity	Displays the status of the activity. Displays whether it has changed or has been added.
Audit Data	Displays the audit data.
Category	Displays the category data.
User	Displays the last user who made changes to the case.
Date/Time	Displays the last time the case was changed. Note: The time displayed is as per GMT.
Print List button	Prints the list of all the logs.

Audit Log Details

The Audit Log functionality tracks all central coding activities for the code-able event and products.

Audit log for the case has the record of the central coding related changes. These changes display the Username as the associated Central Coding Username concatenated with Central Coding.

Multiple selections can be made to view the details of revisions.

To view the Audit Log Details screen

1. Click the Action icon to view the Audit Log Details screen.

2. Click a row displaying a revision to display the details in the upper portion of the screen.

The following table describes the fields in the Audit Log Details screen.

Field	Description
Total Number of Rows	Displays the total number of rows in the list.
Parent	Displays the parent screen where the change has been made.
Field	Displays the field where the change has been made.
Old Value	Displays the previous value.
New Value	Displays the new, changed value.
Rev	Displays the revision number. The list is sorted in descending order of the revisions that have been made so the latest revision is displayed at the top.
User Name	Displays the name of the last user who made a change.
Revisions Date	Displays the last date when the change was made.
User	Displays the name of the user who last made the revision.

Error Log

The Error Log screen provides information about errors that occurred during case processing.

To view the error log

1. Select Utilities --> Logs --> View Error Log.

2. The system opens the Error Log screen.

3. In the Search Conditions section, enter or select a date range and click Search.

4. The system displays the search results in the Total Number of Rows section.

5. Locate the error log you want to view and click to view the error message text.

Search Conditions Section

The Search Conditions section enables you to search for error logs based on pre-defined or custom date ranges.

The following table lists and describes the fields in the Search Conditions section.

Field	Description
Date Range	Select the date range from the given drop-down list. This selection automatically populates the From and To fields.
From	Enter the initial date of the time period to be searched.
To	Enter the end date of the time period to be searched.
Search button	Displays the results of the specified search criteria.

Total Number of Rows Section

Total Number of Rows

The system retrieves the error logs for the specified date range and places the results in the Total Number of Rows section.

The following table lists and describes the fields in the Total Number of Rows section.

Field	Description
Total Number of Rows	Displays the total number of rows in the list.
Argus User Name	Displays the Argus User Name of the user who got the error.
OS User Name	Displays the OS User Name of the user who got the error.
Error Date	Displays the date and time of the error.
Application	Displays the name of the application where the error occurred.
Terminal	Displays the name of the terminal where the error occurred.
Machine	Displays the name of the machine where the error occurred.
Error Text	Displays the text of the error. Note: click the Zoom icon to view the complete text.
Print List button	Prints the list of all the errors.

E2B Screens

The purpose of the E2B Transmit Status and E2B Receive Status screens is to monitor the incoming and outgoing messages and acknowledgments. E2B screens are categorized as:

• E2B Transmit

• E2B Receive Status

To view the E2B screens

1. Select Utilities --> E2B --> <E2B Category>.

2. The system opens the appropriate E2B screen.

E2B Transmit Status Screen

The E2B Transmit Status screen enables you to track outgoing messages. The following is an illustration of the E2B Transmit Status screen:

Description of the illustration e2btransmitstatus.gif

To view E2B transmit status data

1. Select Utilities --> E2B --> E2B Transmit Status.

2. When the system opens the E2B Transmit Status screen:

   • Enter the appropriate search criteria in the Search Reports section.

   • Click Search to display the search results in the Total Number of Rows section.

Search Reports

The Search Reports section enables you to enter information for retrieving transmission information.

The following table lists and describes the fields in the Search Reports section.

Field	Description
Agency/Trading Partner	Select the agency/trading partner as the receiver from this list.
Search button	Displays all the E2b messages and acknowledgments only for the specified receiver. Note: If 'Any' is selected as the Agency, the search results display all messages and acknowledgements for all receivers.
Transmit Date Range	Select this radio button to specify the date range for all transmissions.
From	Enter the initial date of the specified period
To	Enter the end date of the specified period.
Message # Range	Select this radio button to specify the date range for all messages.
From	Enter the initial date of the specified period.
To	Enter the end date of the specified period.
Range	Select the desired range from the list.
Type	Select the desired type from the list.

Total Number of Rows

The system displays the search results in the Total Number of Rows section as shown in the following illustration.

The following table lists and describes the fields in this section.

Field	Description
Total Number of Rows	Displays the total number of rows that displayed in the list, as shown in the parenthesis.
Type	Allows the user to view the type of entity transmitted. Click the Details icon to view the attachment as a PDF.
Reports	Allows the user to view the number of attachments transmitted.
Trading Partner	Allows the user to view the Reporting Destination to which the attachment is transmitted.
Control #	This field is left blank for attachment transmission only.
Local Msg#	Displays the local message number.
Remote Msg#	Displays the remote message number.
File Name	Allows the user to view the filename transmitted by EDI Gateway.
Transmit to EDI	Allows the user to view the date and time when the attachment was transmitted to the EDI Gateway.
EDI Tracking ID	Allows the user to view the EDI Tracking ID.
EDI Transmit Date	Allows the user to view the EDI Transmit Date and Time from the gateway.
Transmission Status	Allows the user to view the Transmission Status of the attachment file transmitted from EDI Gateway such as Failure / Success / Pending.
EDI Receive Receipt	Allows the user to view the date and time of the EDI MDN Acknowledgement date.
Print button	Prints the list.

Type Icon Options

Click the Type icon to view these options:

• Any - Displays all the E2B messages and acknowledgments

• MSG - Double-click on MSG to view messages in the E2B Viewer.

• ACK - Double-click on ACK to view the acknowledgement.

When you click these options, the system opens the Message Acknowledgement screen shown in the following illustration. This screen contains all the safety report detail information such as, if the report is loaded or not loaded with error and enables you to monitor message acknowledgements.

The following table lists and describes the fields in the Message Acknowledgement Status dialog box.

Field	Description
ICSR Message Number	Displays the ICSR Message Number.
ICSR Message Receiver ID	Displays the ICSR Message Receiver ID.
ICSR Message Sender ID	Displays the ICSR Message Sender ID.
Sender Acknowledgement Message #	Displays the acknowledgement message number of the sender.
ICSR Message Date	Displays the ICSR Message Date.
Acknowledgement Message Initiated On	Displays when the acknowledgement was initiated.
Transmission Acknowledgement Code	Displays the Transmission Acknowledgement Code.
Case #	Displays the Case #.
Message	Displays the message.
Authority #	Displays the Authority #.
Local Case #	Displays the Local Case #.
Other #	Displays the Other #.
Report Status	Displays the Report Status.
E2B Report Type	Displays the type of the E2B Report.

E2B Receive Status

The E2B Receive Status screen enables you to monitor incoming E2B messages. The following is an illustration of the E2B Receive Status screen:

Description of the illustration e2breceivestatus.gif

Search Reports

The Search Reports section enables you to search for received messages.

The following table lists and describes the fields in the Search Reports section.

Field	Description
Agency/Trading Partner	Select the agency/trading partner as the receiver from this list.
Receive Date Range	Select this radio button to specify the date range for all transmissions.
From	Enter the initial date of the specified period.
To	Enter the end date of the specified period.
Range	Select a predefined date range from the drop-down list.
Message # Range	Select this radio button to specify the date range for all messages.
From	Enter the initial date of the specified period.
To	Enter the end date of the specified period.
Type	Select the desired message type from the list.
Search	Initiates the search and displays all the E2b messages and acknowledgments only for the specified receiver. Note: If 'Any' is selected as the Agency, the search results display all messages and acknowledgements for all receivers.

Total Number of Rows

The Total Number of Rows section contains the search results.

The following table lists and describes the columns

Field	Description
Total Number of Rows	Displays the total number of rows that displayed in the list, as shown in the parenthesis.
Type	Displays the Type icon containing options.
Trading Partner	Displays the name of the trading partner.
Control #	Displays the control number.
Local Msg#	Displays the local message number.
Remote Msg#	Displays the remote message number.
Total Reports	Displays the total number of reports.
Rejected Reports	Displays the number of rejected reports.
File Name	Displays the file name.
Receive from EDI	Displays the messages received from EDI.
Transmission Status	Displays the Transmission Status.
Print	Enables you to print the list.

Type Icon Options

Click the Type icon to view these options:

• Any - Displays all the E2B messages and acknowledgments

• MSG - Double-click on MSG to view messages in the E2B Viewer.

• ACK - Double-click on ACK to view the acknowledgement.

When you click these options, the system opens the Message Acknowledgement screen. This screen contains all the safety report detail information such as, if the report is loaded or not loaded with error and enables you to monitor message acknowledgements.

The following table lists and describes the fields in the Message Acknowledgement Status dialog box.

Field	Description
ICSR Message Number	Displays the ICSR Message Number.
ICSR Message Receiver ID	Displays the ICSR Message Receiver ID.
ICSR Message Sender ID	Displays the ICSR Message Sender ID.
Sender Acknowledgement Message #	Displays the acknowledgement message number of the sender.
ICSR Message Date	Displays the ICSR Message Date.
Acknowledgement Message Initiated On	Displays when the acknowledgement was initiated.
Transmission Acknowledgement Code	Displays the Transmission Acknowledgement Code.
Case #	Displays the Case #.
Message	Displays the message.
Authority #	Displays the Authority #.
Local Case #	Displays the Local Case #.
Other #	Displays the Other #.
Report Status	Displays the Report Status.
E2B Report Type	Displays the type of the E2B Report.

Argus Reconciliation

The Argus Safety Reconciliation module enables you to configure and edit/reconcile records as per requirements.

Select Reconciliation from the Utilities menu to view the options available under Argus Reconciliation.

Source Database Definition

This Source DB Definition screen enables you to define the mapping of the Reconciliation databases to the Common Interface of the CDMS.

To open the Source DB Definition screen

1. Select Utilities --> Reconciliation --> Source DB Definition.

2. The system displays the Source DB Definition screen.

Description of the illustration sourcedbdef.gif

The following table lists and describes the tables on the Source DB Definition screen.

Field	Purpose
No	Displays the serial number of the row
Active	Enables you to include the reconciliation source in the next reconciliation run
Instance	Displays the name of the instance
Schema	Displays the name of the database schema
CDMS Protocol	Displays the CDMS Protocol
Argus Study Num	Enables you to select a study from the Study Lookup dialog
Access Data using User	Displays the username used to access the data
Password	Displays the password used to access the data
SAE Common Interface View Name	Enables you to specify the view name to be accessed that returns the expected reconciliation fields
Match-up	Enables you to configure a match-up

Editing Source Database Definition

Use the following procedure to edit the source database definition.

To edit the source database definition

1. Click the Active check box, as required.

2. Click Select in Argus Study Num to configure a study that has been set up in Argus Safety.

3. Click Select on the Source DB Definition screen.

4. When the system opens the Clinical Trial Selection dialog box:

   • Enter the appropriate study information (i.e., Project, Study, Center) and click Search.

     
     

     Tip: Enter specific search criteria to refine the search results.

     
     

   • When the system displays the search results in the Total Number of Rows section, locate and click the row containing the study information to be configured.

   • Click Select to configure the selected information.

5. Click Select in SAE Common Interface View Name to configure a view name to be accessed that will return the expected reconciliation fields.

6. When the system opens the Reconciliation Database Connection dialog, modify the database connection details as appropriate and click OK.

Reconciliation Database Connection Fields and Field Descriptions

The following table lists and describes the fields in the Reconciliation Database Connection dialog box.

Field	Description
Database	Enables you to enter the Database Name for fetching the data for the view.
View Schema Owner Name	Enables you to enter the Schema Owner Name.
View Schema Owner Password	Enables you to enter the Schema Owner Name password for connection to the database.
Connect to CDMS Database	Enables you to check if connection is successful or parameters entered are incorrect.
Create New View	Enables you to create a new view for the Database and the corresponding Schema Owner.
Use Existing View	Enables you to select an existing view from the Database and the corresponding Schema Owner.
CDMS View Definition	Enables you to enter SQL statement for the view definition.
Create Public Synonym for View	Enables you to create a Public Synonym for the CDMS View in the CDMS Database.
Grant "SELECT" on View to User / Role	Enables you to grant "Select" permission to the specified User and Role for the CDMS View in the Schema Owner.
Create/Update View	Enables you to create or update the View in the Schema Owner.
Drop View and Public Synonym	Enables you to drop the View and Public Synonyms in the Schema Owner after Creating / Updating / Deletion of the View.
OK	Enables you to return back to the Reconciliation Sources Database Definition dialog.

• 7. Click Select in Match-up to configure a match-up behavior per study.

• 8. When the system opens the Reconciliation Match-up Configuration dialog box:

  • Select an Argus Tab as required, from the Argus Tab drop-down list for the corresponding Reconciliation Field.

  • Select an Argus field as required, from the Argus Field drop-down list for the corresponding Reconciliation Field.

  • Click the Only Reconcile if present in CDMS checkbox to reconcile a field, only if it is also present in CDMS.

  • d. Click OK to save the changes made to the section.

Sample SQL for Creating Views

The following is sample SQL code to use when creating views.

create or replace view RECON_STUDY_A as

SELECT ct_recid, saeid1, saeid2, saeid3, saeid4, saeid5, saesuffix1, saesuffix2,

saesuffix3, saesuffix4, saesuffix5, tracknum, firstaetrack, subpage,

study, pid, ptinit, treatnone, treatdrug, treatnondrug, ae, llt_code,

aestartdd, aestartmm, aestartyy, aestopdd, aestopmm, aestopyy, deathdd,

deathmm, deathyy, severity, appraisala, appraisalb, appraisalc,appraisald,appraisale,

outcome, entry_datetime

FROM A.ae_all

WHERE NVL (status, -1) IN (0, 1)

Interactive Reconciliation

This Interactive Reconciliation screen enables you to view and configure an interactive reconciliation report.

To open the Interactive Reconciliation screen

1. Select Utilities --> Reconciliation --> Interactive Reconciliation.

2. The system opens the Interactive Reconciliation screen.

Description of the illustration interreconciliation.gif

Interactive Reconciliation Screen Fields and Field Descriptions

The following table lists and describes the fields on the Interactive Reconciliation screen.

Field	Purpose
Show Discrepancies Only	Displays only those reconciliation records that contain discrepancies.
Unmatched Records	Displays only unmatched Argus and CDMS records.
Date Ident/Res	Displays the date of resolution.
Status	Displays the status of the record.
Study #	Enables you to select the study number of the record. Note: It is mandatory to select a Study # to perform a search. The default value is the first study in the list.
Inv ID	Displays the Investigator (Reporter) ID of the record.
Pat ID	Displays the Patient ID of the record.
Init.	Displays the event initials.
Death Date	Displays the event death date in the record.
SAE ID	Displays the SAE ID of the record.
SAE ID Suffix	Displays the SAE ID Suffix of the record.
Verbatim	Displays the verbatim of the event for the record.
LLT	Displays the LLT for the record.
Start	Displays the event start date for the record.
Stop	Displays the event stop date for the record.
Intensity	Displays the event intensity level of the record.
Treatment	Displays the event status on treatment of the record.
Outcome	Displays the event outcome of the record.
Causality	Displays the event causality status for the record.
Search	Enables you to search for cases that match the specified filter criteria.
Print List	Prints the displayed list as a PDF.

Editing Interactive Reconciliation Reports

The Interactive Reconciliation Report screen enables you to edit and configure interactive reconciliation reports.

Be aware of the following:

• You can search for records by entering a filter criterion below the header row.

• If multiple filter criteria are specified, only those records that meet all the specified criteria are displayed. For example, select the filter criteria for Status as Approved, enter Pat ID as 1234 and click Search.

• Only the record with Patient ID 1234 and Status as Approved, will be displayed in the search results.

  
  

  Tip: Click Clear Filters to remove all the search criteria entered under different headers such as Unmatched Records, Status, Study #, etc.

  
  

Applying a Filter

Use the following procedure to apply a filter.

To apply a filter

Right-click on any column header to display the filtering criteria.

Filter on Reconciliation Status Filtering Options

The following table lists and describes the Filter on Reconciliation Status options.

Filtering Option	Purpose
No Discrepancy	Enables you to view only those records that do not have any discrepancy between Argus and CDMS records. This displays the selected filtering criteria in green.
Accepted	Enables you to view only Accepted records. The color associated with this filtering criteria is orange.
Pending	Enables you to view only Pending records. The color associated with this filtering criteria is red.
(Any)	Enables you to view all records, irrespective of their status. The color associated with this filtering criteria is blue.

Configuring an Interactive Reconciliation Report

Use the following procedure to configure an Interactive Reconciliation Report

To configure an Interactive Reconciliation Report

1. In Unmatched Records, click the Yes check box to filter out any paired records and view only unmatched Argus and CDMS records.

2. Select the Status of the record such as Pending or Accepted, as required.

   • Click any cell within Pending records to display the Reconciliation Options menu, containing the Accepted and Pending options.

   • Select Accept to accept the discrepancy for the selected field and change the status to Accepted.

3. When the system opens the Justification dialog:

   • Enter a justification for changing the status in your own words in the Please enter a justification for performing this action text box

     OR

     Select a justification from the drop-down list containing pre-defined justifications.

   • Click Add.

   • Click OK.

4. 
   

   Tip: Alternatively, you can also click the orange/red icon denoting the status of a record to view the Justification dialog.

   
   

5. Enter other filter criteria such as Study #, Pat ID, SAE ID, etc., as required.

6. Click Search.

7. The results matching the specified filter criteria are displayed in Total Number of Rows.

Manually Matching Unmatched Records

Unmatched records are CDMS records that do not match with Argus cases. These records are listed in the CDMS Records Not Matched to Argus Case section.

To manually match unmatched records

1. Select the record to be matched from the CDMS Records Not Matched to Argus Cases section.

2. Select Attach to the desired Argus record.

3. The system matches the record to Argus.

Note: The icon in the Status column of a record denotes that it has been matched manually.

Reconciliation Scheduling

Reconciliation Scheduling enables you to run a reconciliation now or schedule a time for the reconciliation for a later date.

To open the Reconciliation Scheduler dialog box

1. Select Utilities --> Reconciliation --> Reconciliation Scheduling.

2. This displays the Reconciliation Scheduler dialog box.

Description of the illustration reconciliationsched.gif

Reconciliation Scheduler Dialog Box Fields and Field Descriptions

The following table lists and describes the fields in the Reconciliation Scheduler dialog box.

Field	Purpose
Select Days of the Week	Enables you select the days of the week when the scheduler will run.
Select Start Time	Enables you to specify the time when the scheduler will run.
Run Now	Runs the scheduling as soon as this button is selected.

Editing Reconciliation Scheduling

Editing the reconciliation scheduling from the Reconciliation Scheduler dialog box shown in the following illustration.

Description of the illustration reconciliationsched.gif

To edit reconciliation scheduling

1. Select the days for which the reconciliation is to be scheduled in the Select Days of the Week section.

2. Specify the time (hh:mm:ss AM/PM format) for the reconciliation to start in the Select Start Date and Time section.

3. Click OK.

4. The system schedules the reconciliation for the specified days and time.

Case Undelete

The Case Undelete option enables you to restore deleted cases.

To restore deleted cases

1. Select Utilities --> Case Undelete.

2. When the system opens the Undeleted Cases screen, enter the appropriate information in the Case Search Criteria fields and click Search.

Description of the illustration caseundelete.gif

Case Search Criteria Fields and Field Descriptions

The Case Search Criteria enables you to enter information to help you retrieve deleted cases.

The following table lists and describes the fields in this section.

Field	Description
Case Number	Enables you to enter the number for a specific case.
Date Range	Enables you to select a date range from which cases may be selected. The selection made from the Date Range drop-down list automatically populates the From and To fields.
From	Displays the initial date of the search period
To	Displays the end date of the search period
Search	Click to display the Search results that match the specified search criteria

1. When the system displays the search results in the Total Number of Rows section:

   • Locate the case you want to restore and click the check box associated with its case number.

   • Click Case Undelete.

Total Number of Rows Fields and Field Descriptions

The system displays the search results in the Total Number of Rows section on the Case Undelete screen.

The following table lists and describes the columns in the Total Number of Rows Section

Field	Description
Total Number of Rows	Displays the total number of rows in the list
Check Box	Enables you to select the case to restore.
Case Number	Displays the case number of each deleted case.
Initial Receipt Date	Displays the initial receipt date of the case.
Product	Displays the product category that the belongs to.
Event	Displays the event related to the deleted case.
Workflow State	Displays the workflow state of the case.
Serious	Displays if the deleted case was serious or not.
Deleted By	Displays the name of the user who deleted the case.
Deleted Date	Displays when the case was deleted.
Justification	Displays the justification for deleting the case. Note: Click the check box corresponding to the case to view the justification for its deletion.
Case Undelete	Displays the Justification dialog box. Enables you to restore the selected case number.
Print List	Prints the current worklist for reference.

1. When the system opens the Action Justification dialog box:

   • Enter the justification manually in the Please enter a justification for performing this action field

     OR

     Select a preconfigured justification from the Select a standard justification for this field drop-down list.

   • Click OK.

General Usage Information

When using Case Undelete functions, be aware of the following:

• You can search for a specific case from the Case Undelete dialog shown in the following illustration.

• If you enter the Case Number to search for a specific case, the following apply:

The system disables the date range fields including From and To.

If you enter an invalid case number, the system displays the following message:

The Case Number entered is not valid. Please enter a correct Case Number and search again.

• You can configure the number of cases to display in the Case Undelete dialog box from the Page Size drop-down list.

• The Page Size drop-down list contains the following values:

  • 50

  • 100 (default)

  • 250

  • 500

  • 1000

  • 2000

• The system displays the number of cases currently in view and automatically updates the range as defined by the Page Size drop-down list. For example, if you select 100, the system separates the rows to display into groups of 100 cases.

• You can go directly to a range of cases by selecting a range from the Displaying Rows drop-down list.

• You can scroll through the Case Undelete search results in page-by-page increments as defined in the Page Size drop-down list.

Action Justification Dialog Box Fields and Field Descriptions

The following table lists and describes the fields in the Action Justification dialog box.

Field	Description
Please enter a justification for performing this action	Enter the text that justifies the need to un-delete a case.
Select a standard justification for this field	Contains standard, pre-configured descriptions of justifications for un-deletion.
Spell Check	Checks the entered/selected text for any grammatical errors.
OK	Saves the justification entered/selected for case un-deletion.
Cancel	Exits out of this dialog without saving any justification.

Batch Reports

The Batch Reports dialog displays a list of those batch reports that have been scheduled for generation.

To view a list of batch reports

1. Select Batch Reports from Utilities in the menu bar.

2. The system opens Batch Reports dialog box with a list of batch reports along with their report titles and next run dates.

Description of the illustration batchreportsdb.gif

To delete a batch report from the list

1. Select the check box corresponding to the batch report to delete.

2. Click Delete.

Blank Report Forms

The Blank Report Forms screen enables you to view and print blank report forms for the following reports:

CIOMS-I US FDA MedWatch 3500A US FDA VAERS EU EMEA Clinical EU EMEA Spontaneous EU Device Vigilance Initial EU Device Vigilance Final German BfArM Form 643

German PEI Form 643 French CERFA MCA Clinical MCA Spontaneous US FDA MedWatch 3500A Drug MHLW Spontaneous MHLW Clinical CERFA 65-0044

CIOMS-I (Local) CERFA 65-0040 Spanish Clinical Spanish Spontaneous Canadian Device Form Canadian ADR Case Form

To view and print blank report forms

1. 1. Select Utilities --> Blank Report Forms.

2. 2. When the system opens the Blank Report Forms screen, locate the form you want to view or print and click its Name.

   
   Description of the illustration blankreportforms.gif
   
   

3. 3. The system opens the selected form in PDF format.

End of Study

When a study is complete, use the End of Study utility to unblind all the cases associated with the study at the same time instead of unblinding them one by one.

To unblind a study

1. Select Utilities --> End of Study.

2. The system opens the End of Study Unblinding dialog box.

Description of the illustration studyunblinding.gif

End of Study Unblinding Dialog Box Fields and Field Descriptions

The following table lists and describes the fields in the End of Study Unblinding dialog box.

Field	Description
Display only Unbroken cases	Enables the user to view only unbroken cases
End of Study Unblinding	Only those studies that are "Eligible for unblinding" (as determined via List Maintenance) are displayed in this list. Select a study from this list. This populates the list of cases based on the study chosen.
Case ID	Displays the ID of each case.
AE Date	Displays the Associated Event Date for the case.
Pat ID	Displays the Patient ID.
Rand No	Displays the Randomization Number of the case.
Drug Received	Displays the name of the drug received.
Dosage	Displays the Select button to view the Dosage Regimens screen.

1. Select the appropriate study from the End-of-Study Unblinding drop-down list.

2. When the system displays the selected information, locate the appropriate study and click Select in the End of Study dialog.

3. When the system opens the Dosage Regimens dialog box, enter the drug dosage information as required.

4. Click OK to save the changes, update the cases, and close this dialog.

   
   

   Note: For each case that is unblinded by this method, the Blinding Status is adjusted to "Broken After Study" if the study type is single or double blinded and fills information about the Unblinding Date, Study Drug, Follow-up Received Date, Mark case as Significant, and Dosage Regimen.

   
   

Clear Cache

A cache contains a record of the items you have seen or downloaded from the Web, including images, logs of Web pages, etc. Typically these items are stored in the Temporary Internet Files folder.

Storing these files in your cache can make browsing the Web faster because it usually takes your computer less time to display a Web page when it can call up some of the page's elements or even the entire page from your local Temporary Internet Files folder. If you believe that you have a less than current version of a page, you can clear the cache in your browser to avoid viewing the same page again. Clearing your cache can significantly improve the speed and performance of your browser.

To clear your cache of previously stored information

1. Select Utilities --> Clear Cache.

2. The system clears the cache and displays the following message in the Clear Cache dialog box.

Description of the illustration clearcache.gif

Advanced Condition Library

The Advanced Condition Library option enables you to access the advanced condition library and do the following:

• Create a new advanced condition

• Reassign an advanced condition

• Set advanced condition permission levels

• Modify an existing advanced condition

• Delete an advanced condition

• Print a list of advanced conditions

To open the Advanced Condition Library

1. Select Utilities --> Advanced Condition Library.

2. The system opens the Advanced Condition Library screen.

Description of the illustration advcondlibrary.gif

For further information about Advanced Conditions, see chapter 6 of this document.