Actigy BPO · Healthcare and life sciences
ICSR case handoff checklist for pharmacovigilance teams
Actigy BPO prepares individual case safety reports (ICSRs) for client safety teams to review. Use this handoff checklist to record source versions, follow-up information, possible duplicates and outstanding questions. The client’s safety function owns medical judgments and submission.
Free to use · No email required · Calculations stay in your browser
Make the assumptions visible
Check a safety case handoff for operational gaps
Start with the fictional example or enter your own planning assumptions. Use the Excel download for a multi-row record.
Check the initial worked example
In the fictional example, the source and receipt time are present, but the suspected follow-up has no documented duplicate check and no assigned safety reviewer. Those two items stay open. A complete administrative record does not establish validity, seriousness, causality, reportability or a filing deadline.
A repeatable method
How to use the worksheet
For pharmacovigilance operations managers coordinating intake, follow-up and quality review in the client’s approved safety system.
Download the editable workbookRecord initial receipt and later follow-up as separate events. Note the time zone, source type and source version according to your procedures.
Trace new information to its source. Flag possible duplicate records and uncertainty for the designated reviewer. Preserve the original event history.
Assign outstanding questions, urgent escalation and quality review to a named role. Record when the client reviewer accepted the handoff.
Illustrative · Not a client result
A second worked example
A follow-up message adds a medicine start date to an open file. The processor preserves both receipt times and the source versions, flags a possible duplicate and identifies the new field for review. The safety owner decides whether records should be linked and what must be reported.
Keep the decision with its owner
What this tool can establish
This is an original operational worksheet, not a validated safety system or a filing standard. It does not determine clinical seriousness, reportability, causality or a regulatory deadline. Use fictional case references only.
Check the method
Sources and reuse
The examples and calculations are original Actigy BPO material. These sources explain the underlying workflow.
- EMA: good pharmacovigilance practices, Module VI and duplicate management guidance
- PrimeVigilance: case processing services
Suggested citation: Actigy BPO, ICSR case handoff checklist for pharmacovigilance teams. Link to this page so readers can check the method and download the current version.
Published · Updated
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