To view, change, or retrieve case-related information, hover the Utilities menu.
When you log in to Argus Safety for the first time, change the password that has been assigned to you.
Note:
LDAP users cannot change their passwords.From the Utilities drop-down menu, select Change Password.
Enter the parameters, and click OK.
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.
To view the MedDRA browser screen, from the Utilities drop-down menu, select MedDRA Browser.
To view a list of all the current users and their security levels, from the Utilities drop-down menu, select User Login List.
This screen also displays a list of all the currently logged in users.
To sort the displayed records, click a column heading.
By default, the list appears in the ascending order based on the Login Time.
To sort the displayed records, click a column heading.
To configure the number of cases that appears on one page, from the Page Size drop-down list, select a value. By default, the value is 100.
To go directly to a range of cases, from the Displaying Rows drop-down list, select a range.
You can select multiple users or click the All users checkbox in the header.
To reset a user, select a user, and click Reset User. All the selected users in the list. are reset.
You cannot reset your login username.
Logs are a repository of all the cases in the database, displaying the following entries:
Activity
Audit Data
User ID
Date.Time
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 log all the cases.
To view an audit log, from the Utilities drop-down menu, select Logs > View Audit Log.
To search the logs, in the Search Conditions section, enter or select a criteria, and click Search.
To view all the updates performed by the user, from the Category drop-down list, Select All.
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.
The search results appear 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. |
To print all the logs, click Print List.
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
Click the Action icon.
To display the details, click a row with a revision.
To track changes made while using the LAM module, from the Utilities drop-down menu, select LAM Audit Log.
Argus Safety Audit Logs:
To view all updates made by a user, from the Category drop-down list, select <ALL>.
To enable the Search button, from the drop-down list, select a User Name.
The default User Name is updated as the name of the user who is logged in.
The category is identified on the UI.
The print list displays the Category.
The element field label is updated based on the selected category. If you do not enter an element value, the audit details are returned as-is.
You can view all revisions at the same time by selecting the checkbox near the revisions column. The entire audit trail for the elements is displayed.
Argus Affiliate Audit Log
You can filter for a specific Affiliate event in the audit log.
You can view all revisions at the same time by selecting the checkbox near the revisions column. The entire Audit trail for the elements is displayed.
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 perform local labeling 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 that you have selected.
Search Conditions
The Search Conditions section enables you to enter information for retrieving the audit logs you want to view.
Total Number of rows
The search results are displayed 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. |
| User | Displays the last user who made changes to the case. |
| Date/Time | Displays the last time (as per GMT) the case was modified. |
| Print List button | Prints the list of all the logs. |
To view the error log for information about errors that occurred during case processing:
From the Utilities drop-down menu, go to Logs > View Error Log.
To search for error logs based on pre-defined or custom date ranges, in the Search Conditions section, enter a value, and click Search.
The search results appears in the Total Number of Rows section.
Locate the error log you want to view, and click to view the error message text.
Click the Zoom icon to view the complete text.
To monitor the incoming messages, outgoing messages, and acknowledgements, go to Utilities > ICSR > <ICSR Category>.
To track outgoing messages:
From Utilities, go to ICSR > ICSR Transmit Status.
In the Search Reports section, enter the search criteria, and click Search.
The search results appear in the Total Number of Rows section.
If the Agency is selected as Any, the search results display all ICSR messages and acknowledgements for all receivers.
Table 10-1 ICSR Transmit Search Results
| Field | Description |
|---|---|
|
Type |
Click the Details icon to view the type details 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. |
|
File Name |
Allows the user to view the filename transmitted by the EDI Gateway. |
|
Transmit to EDI |
Allows the user to view the date and time when the attachment was transmitted to the EDI Gateway. |
|
EDI Receive Receipt |
Allows the user to view the date and time of the EDI MDN Acknowledgement date. |
Click the Type icon to view the options:
Any—Displays all the ICSR messages and acknowledgments.
MSG—Double-click MSG to view messages in the ICSR Viewer.
ACK—Double-click ACK to view the acknowledgement.
On click of any above-mentioned option, the Message Acknowledgement screen appears.
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.
To monitor incoming ICSR:
From Utilities, go to ICSR > ICSR Receive Status.
In the Search Reports section, enter the search criteria, and click Search.
The search results appear in the Total Number of Rows section.
If the Agency is selected as Any, the search results display all ICSR messages and acknowledgements for all receivers.
Click the Type Icon to view message options.
To restore deleted cases:
To restore deleted cases, hover Utilities, and click Case Undelete.
To retrieve deleted cases, in the Case Search Criteria fields, enter the value, and click Search.
The search results appear in the Total Number of Rows section.
Check the checkbox for the case number to restore it.
Click Case Undelete.
In the Action Justification dialog box:
In the Please enter a justification for performing this action field, enter the justification manually.
From the Select a standard justification for this field drop-down list, select a pre-configured justification.
Click OK.
To view a list of batch reports that are scheduled for generation:
From the Utilities drop-down menu, select Batch Reports.
To delete a batch report, select the corresponding checkbox, and click Delete.
When a study is complete, you can unblind all the cases associated with the study at the same time instead of unblinding them one by one.
From the Utilities drop-down menu, select End of Study.
The End-of-Study-Unblinding (EOSU) dialog box appears.
EOSU does not pick a case that is globally or locally unlocked, or pending local or global report submission.
From the End-of-Study Unblinding drop-down list, select a study.
In the Dosage Regimens dialog box, enter the drug dosage information.
Click OK.
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 enters the following information: \Unblinding Date
Study Drug
Follow-up Received Date
Mark case as Significant
Dosage Regimen
To remove all the previously stored information, from the Utilities drop-down menu, select Clear Cache.
From the Utilities drop-down menu, select Advanced Conditions Library.
From this screen, you can:
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
For more information, see Chapter 12, "Advanced Conditions."
To search for an existing query sets or advanced conditions, enter the search criteria, and click Search.