During studyCloseoutArchive
Catch gaps while they are still easy to fix
Missing records are easiest to recover while sites and study staff are still active, not after the study is over.
You receiveA report for each review that alerts you to hidden issues and assesses prior corrective actions.
During studyCloseoutArchive
Close out or transfer with a clear remediation list
See what remains open before you sign off or accept a TMF transfer, and fix it while the team is still in place.
You receiveA final report: the gaps that remain and a remediation list to close them.
During studyCloseoutArchive
Archive a TMF you can stand behind
Confirm your team completed any corrective and preventive actions (CAPA), and fix what is left before migration.
You receiveA report documenting which planned remediation steps are complete, with supporting evidence and any remaining issues.