What do you need to perform SAE Reconciliation?

During the startup period discuss with your Safety representative how often reconciliation should be performed. Also the variables to be reconciled and how the process will unfold. During your initial meetings with the Safety meeting ask these questions:

1. How often would you like SAE reconciliation to be performed? Monthly, Quarterly etc
2. Which Functional areas (or CRO) will be responsible for performing the reconciliation?
3. What variables on the AE form would you like reconciled with the output from your Safety Database? (NOTE FOR TRAVIS – At this section, it would be nice to have two Computer screens, both with AE data with lines matching them up. A little humor, but also gets the point across.

Please confirm where you would like the data to have Exact matches vs Logical matches. Example:

 

Subject Number	Exact Match
Onset Date	Exact Match
End Date	Exact Match
Verbatim Term	Logical Match
Preferred Term	Exact Match
Outcome	Exact Match
Relationship to Study Drug	Exact Match
Serious Criteria for the SAE	Exact Match
Action Taken with Study Drug	Exact Match
Severity	Exact Match

 

4. If there are no SAEs for a particular period, would you like an email denoting there was no SAEs for that period or is there a form to be signed off?
5. Confirm with your department SOPs, Work Instructions and/or processes if there is a final sign off form for all SAEs at the end of the study?

Based on the DM (or CROs) SOPs and Work Instructions, decide where the details of the SAE reconciliation process will be documented. Typical locations are the Data Management Plan (DMP), Safety Management Plan (SMP) or SAE Plan.