Keeping Your Own House in Order

Part of Sub-Investigator (SUBI) Training: Inspection Readiness and Your Own Record.

About 1 minutes. Free, in your language, no account needed.

Four things with dates, and they all expire quietly

Your delegation entry. Your GCP training. Your protocol training, at the current version. Any protocol-specific certification.

Each invalidates work done after it lapses, and none of them announce themselves.

Check them quarterly

Ten minutes, four dates. It prevents findings that cannot be fixed retrospectively, because you cannot retrain in the past.

Keep your CV current and dated

An out-of-date CV is a standard finding and it takes minutes to fix. It should show your current post and be signed and dated.

Know which protocol version you are working to

Amendments change requirements. Working correctly to a superseded version is still a deviation.

Check the version on the copy you are reading, and confirm your training on the current one is recorded.

Keep a list of what is outstanding

Results to review. Attributions to complete. Queries to answer. Deviations to report.

Things are rarely refused; they are forgotten. A list is the difference.

Review results promptly, and sign them

An unreviewed laboratory report is both an inspection finding and a real safety risk. Somebody flagged a value and nobody looked.

When you leave the study

Your delegation entry gets an end date and your outstanding items are handed over. Half-finished attributions from a departed sub-investigator are difficult to resolve.

None of this is administrative

Every item above is a control that exists because a participant was harmed once when it was missing. That is worth remembering when the delegation log feels like paperwork.