eTMF inspection readiness and sponsor oversight
eTMF inspection readiness for small biotech sponsors, with CRO oversight evidence aligned to ICH E6(R3).
Common TMF findings
Missing or late documents, poor metadata, and QC done only at archiving.
What ICH E6(R3) asks sponsors to show
Ongoing oversight of CROs and vendors: qualification, a responsibility matrix, KPIs and governance records.
TMF audit and QC
A TMF audit against the plan for completeness and timeliness, with QC throughout the study.
Ongoing CRO oversight
CRO audits and oversight evidence. See CDMO, CRO and vendor audits.
FAQ
- How do you prepare an eTMF for inspection?
- Check completeness and timeliness against the plan, fix metadata, run QC throughout the study rather than at archiving, and document CRO oversight.