Clinical trial provenance · Practical guide
What is clinical trial provenance?
Clinical trial provenance is the traceable relationship between a material trial claim and the public evidence that supports, qualifies or conflicts with it.
What does clinical trial provenance actually add?It makes the evidence path portable. Instead of receiving a summary with detached links, a reviewer receives the observation, source, retrieval context, explicit uncertainty and integrity artifacts together.
What to look for
UNKNOWN remains explicit when evidence is absent
Conflicts remain visible instead of being silently resolved
A manifest lets the recipient check the delivered files
When a Provenance Pack is useful
Use a Provenance Pack when a trial summary will cross teams, inform diligence or outlive the analyst who assembled it.
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.