The sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.
The clinical trial master file contains the essential documents relating to that clinical trial as specified in the Guideline for good clinical practice E6. The essential documentation in the trial master file shall take into account all characteristics of the clinical trial including in particular whether the clinical trial is a low-intervention clinical trial. For instance instructions for handling, shipping records, certificates of analysis of IMP’s, temperature monitoring records, drug accountability records if IMP is supplied to patients via a routine medicine supply chain (from the pharmacy, based on medical prescription). See also the recommendations of the expert group on clinical trials for the implementation of the CTR on Risk proportionate approaches in clinical trials.
For data collected in clinical trials with advanced therapy medicinal products (ATMPs) a minimum retention period of 30 years is required. This requirement is laid down in article 6.37 of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.
The clinical trial master file kept by investigator and that kept by sponsor have a different content because of the different responsibilities.
The medical files of the subjects shall be archived in accordance with national law, which is minimal 20 years in the Netherlands.