Clinical trial provenance · Practical guide
Clinical trial due diligence: what should be inspectable?
A diligence summary is more useful when each material conclusion can be traced back to the public evidence reviewed.
What should a diligence reviewer be able to inspect?At minimum: the public record consulted, when it was retrieved, which claims depend on it, where sources disagree, what remains unknown and whether the delivered evidence package changed.
What to look for
Outcome and enrollment observations
Publication relationships based on exact identifiers
Open conflicts and limitations
When a Provenance Pack is useful
Use a Provenance Pack when investment, licensing or partnership review depends on facts assembled from multiple public sources.
This method assesses evidence lineage and package integrity. It does not establish clinical truth, FDA validation, regulatory certification, GxP or 21 CFR Part 11 compliance.