Dear all, since EU CTR 536/2014 came into force, trial master file (both, sponsor and investigator parts) has to be archived for 25 years. While this is obvious for investigators in EU, what about investigators in US?
The Q&A document issued by EMA states that “Clinical trials conducted outside the EU, but referred to in a clinical trial application within the EU, will have to comply with regulatory requirements that are at least equivalent to those applicable in the EU”.
Can/shall we ensure that ISF documentation from US sites is also archived for at least 25 years based on that? Any advice is much appreciated. Thank you!
You are correct; retention times need to support your product registration/marketing activities. So if you plan to secure marketing approval in the EU, your retention times need to meet EU requirements, currently 25 years after closure of the trial. It is common practice for the expected retention time to be clearly shown in the clinical trial agreement with the site so that they understand their obligations right from the outset. The sponsor can provide financial support to ensure document retention but must never have direct access to the ISF or store the records on behalf of the site. Many sponsors use independent third parties to arrange storage on their behalf.