- Published
- Updated
- Sources checked
Annual reporting is a study-status reconciliation exercise. Copying last year's narrative can conceal closed sites, revised enrollment figures or a protocol version that no longer matches the active study.
Set a defined reporting cut-off
TİTCK publishes annual notification module information alongside its application guidance. Check the current reporting requirements and the study-specific reporting calendar before planning dispatch. Do not confuse progress reporting with a development safety update report; they may draw on shared data but address different purposes.
Build one reconciled snapshot
We recommend a dated snapshot combining country and site status, participant counts, current protocol version and material changes. Define each count, including screened, enrolled, ongoing and completed participants, so clinical operations and data management reconcile the same concepts. Record unresolved differences explicitly and assign a resolution owner.
Check the reporting package
- Confirm the reporting period, required recipient and current module instructions.
- Reconcile enrollment totals with site records and the agreed data cut-off.
- Check added or closed sites, suspensions and protocol changes against the tracker.
- Preserve the submitted snapshot, approvals, receipt and any subsequent correction history.
Keep later changes traceable
After submission, keep the snapshot frozen as evidence of what was reported. Later database updates should create an explained correction assessment rather than silently overwriting the historical report. Carry open actions into the next review with responsibility and an internal target date.
Frequently asked questions
- Can the safety report replace the annual progress notification?
- Assess each applicable requirement separately; one report's existence does not establish completion of the other.
- Must counts match today's live dashboard?
- They should match the defined reporting cut-off and definitions, with any later changes explained.