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NEWS STRAIGHT FROM THE LIBRARY

Archiving – How long?

EMA/15975/2016 (“Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials”) Section 6.4:

« For trials conducted under Directive 2001/20 EC, the sponsor and the investigator must ensure that the documents contained, or which have been contained, in the TMF are retained for at least 5 years after the conclusion of the trial (GCP-Directive Article 17) or in accordance with national regulations (e.g. in Germany GCP-V §13(10): 10 years).

« For trials conducted under Regulation 536/2014, per Art. 58:  “unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical TMF for at least 25 years after the end of the clinical trial. »

Directive 2003/63/EC (i.e. Amendment M2 of the Community Code 2001/83/EC introducing the revised Annex 1):
« Trials where the data are used to support a marketing authorisation have further requirements and must be retained for at least 15 years after completion or discontinuation of the trial or for at least two years after the granting of the last marketing authorisation in the EC (when there are no pending or contemplated marketing applications in the EC) or for at least two years after formal discontinuation of clinical development of the investigational product. »

« Directive 2003/63/EC states that the sponsor or other owner of the data must retain some of the documentation for as long as the product is authorised: « … Additionally, this documentation must include (as a minimum) the trial protocol (which must include the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, details of the investigational product, the reference medicinal product and/or the placebo used), any standard operating procedures used for conducting the trial, all written opinions on the protocol and procedures, the investigator’s brochure, case report forms on each trial subject, final report and audit certificate(s), if available, staff training records. Finally, the final report must also be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorised. »

ACPS-Comment: Obviously there is no simple answer except that the essential trial documentation needs to be retained for a very, very long time. This poses a major logistical problem for the archiving of the essential trial documentation that is to be kept by the investigator (ISF: Investigator Study File). Indeed, ISF are distinct from the essential trial documentation that is to be kept by the sponsor (TMF: Trial Master File) and the ISF cannot simply be archived by the sponsor on behalf of the investigator – See also TMF & ISF | Can the sponsor archive the ISF?

{08.Nov.2018 | ACPS-CdM}