Article 57 requires the sponsor and the investigator to keep a clinical trial master file (TMF) containing the essential documents that demonstrate compliance with the Regulation and the principles of GCP. Article 58 requires the TMF to be archived for at least 25 years after the end of the trial, unless other Union law requires a longer archiving period. The personal data of subjects in the TMF is deleted at the end of the archiving period.
This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.