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Each pharmaceutical and biotechnology company are required by law to
capture and report adverse event data on their drug, device and vaccine
products
- Each adverse event the company becomes aware of is reviewed and
entered into the Argus Safety suite of modules
- The two primary modules used in adverse event case processing are
Argus Affiliate and Argus Safety
- Argus Affiliate and Argus Safety enable users to process Individual
Case Safety Reports (ICSRs), otherwise known as cases, through the
complete life cycle from receipt of information to submission of reports
to regulatory authorities
ORACLE ARGUS SAFETY DATABASE
Argus Affiliate is used to capture cases at a local level and submit them
for central processing in Argus Safety
- Argus Safety provides a full service workflow to manage the processing
of cases and to ensure compliance with regulatory requirements.
The Argus Safety workflow ensures structure of case processing and
also retains an audit trail of the entire workflow process:
Argus divides the case processing workflow into units of work called
“states”.
Each workflow state is a set of items that can be performed by a defined
user or a group in a pre-defined sequence
Argus tracks the movement of each case that has been entered, from one
required workflow state to the next, until the case has been fully
processed and closed
Who Performs Case Processing (User Groups)
Data Entry
- Administrative assistant or data entry person
- No medical background required
- Performs initial receipt of case and full data entry
Case Triager
- Medical background required, HCP (e.g. RN or Physician)
- Empowered to make decisions that impact case processing timelines,
e.g. seriousness, relatedness, expectedness determinations
Quality Controller
- Reviews the accuracy of the case data entered into Argus
- Typically has some level of medical background or supervisory skills
Medical Reviewer
Typically a physician but could be other HCP (company dependent)
Unblinding Group
- Medical reviewer will make the decision to unblind
- Act of unblinding usually done by another group or by Data Entry
Expedited Reporting
- Distributes reports to partners
- Submits reports to regulatory authorities
- Ensures E2B reports acknowledged successfully
Case Triage
Who
Tasks
- Determine if minimum criteria for a case have been met
- Review results of duplicate search and determine if the case is a
duplicate or not
- Determine reportability (expedited or not) and associated timeline
- Determine what (if any) follow-up information is required – immediate
follow-up may be done during case triage
- Assign an owner for the case (optional)
- Route the case to Data Entry
Considerations
- The assessment at triage sets the timeline and direction of the case,
therefore it is important that it is performed by a person suitably
qualified.
Data Entry
Who
Tasks
- Enter all case data (initial case, follow-up case, corrections from QC
or Medical Review)
- Dictionary coding
- Create / update case narrative
- Run validation checks and ensure case passes all validations
- If follow-up is required it may be done at this point
- Route the case to QC
Considerations
- Larger companies tend to have lower level data entry staff enter the
data and then have someone else review
- Smaller companies tend to have more highly trained resources with
medical background “own” the case from beginning to end.
Medical Review
Who
Tasks
- Review of case in general including case narrative, causality
assessments, seriousness assessments, listedness assessments
- Determine if the case requires unblinding
- Determine if additional follow-up items required or if the case is ready
for closure after reporting
- Minor corrections made at medical review
- Major corrections noted and the case routed back to Data Entry or QC
for corrections to be addressed
- Route case to Unblinding or Approval
Considerations
- Some Physicians prefer to perform medical review outside of Argus and
then have another Argus user document the findings in the system, add
updates and comments to the case and route it to the next step.
Who
Tasks
- Retrieve unblinding information as per the study protocol
- Unblind the product data in Argus and select the treatment product
the patient was given
- Route case to Distribution
Considerations
- Only users with specific unblinding privileges can perform
unblinding in Argus
- After a case has been unblinded, the user can still send a blinded
report to partners or authorities if required.
Unblinding
Distribution
Who
- Expedited Reporting Group
Tasks
- Distribution of the ICSR to:
- Regulatory Authorities
- Trading Partners
- Affiliates
Considerations
- How to handle changes to core case data when an error
acknowledgement for an electronic submission is received. One of the
following approaches is usually taken:
- Unlock the case and leave it in the distribution workflow state, make
the corrections and lock the case again
- Unlock the case and route it back to Case Triage – case goes through
the whole workflow again
Follow-up Pending
Who
Tasks
- Monitoring of follow-up due dates
- Sending follow-up reminders
- Handling cases where requested follow-up information is not received
Considerations
- Typically three attempts to obtain additional information about a case
are made. After the third attempt the case will be closed.
The number of attempts made varies by type of case and company policy
Argus Safety Configuration Process Overview
To configure Argus Safety, the Administrator must follow a particular
sequence of steps. Steps that fall later in the sequence might depend on
those that appear earlier. It is, therefore, important for the Administrator
to use the following flowchart as a guideline for configuring Argus Safety.
Tip:
■ The modules display in bold text identify the modules you have
permission to access.
■ Your login user ID and password are valid for all accessible Argus
modules.
■ This is the single point of login for all the Argus modules.
Enter the User Name and Password to login to Argus Safety.
Note: The password is case-sensitive.
Select the database name from the drop-down Database list.
Press Enter or click Login.
Click Argus Console to launch the Argus Console Administrator screen.
Changing the Administrator's Password
Select Utilities -> Change Password in Argus Safety.
The Change Password dialog opens.
Enter the current password and the new password.
Confirm the new password and click OK.
Logging out
Click Close to log out from the Argus Console application.
To log out at any time from Argus, click Logout.
Required Fields
Fields that are marked with a red flag image and associated with an
orange boundary are required fields. These fields must be filled in, to
proceed with the configuration requirements.
