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Thread: Minimum retention period for the sponsor

  1. #1

    Minimum retention period for the sponsor

    European Directive 2003/63/EC describes the minimum retention periods for trial records. However, the wording is quite ambiguous and has been interpreted differently by different organisations. It states:

    Marketing authorisation holders must arrange for essential clinical trial documents (including case report forms) other than subject?s medical files, to be kept by the owners of the data:

    ? 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 European Community and when there are no pending or contemplated marketing applications in the European Community,
    ? or for at least two years after formal discontinuation of clinical development of the investigational product.


    The document then goes on to say:

    The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorised. This documentation shall include: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used; standard operating procedures; all written opinions on the protocol and procedures; the investigator?s brochure; case report forms on each trial subject; final report; audit certificate(s), if available.

    It is not clear why core essential records need to be retained for 15 years or approval/discontinuation plus 2 years whereas all other records pertaining to the trial need to be kept for as long as the product is marketed. One interpretation is that the first (shorter) requirement applies to the investigator site file only, since the text mentions the exclusion of subject medical files, while the 2nd requirement applies solely to the sponsor records. Is this the common interpretation of these requirements? If not, how do you account for the apparent mis-match between these two retention requirements? If indeed ALL trial records need to be retained for the lifetime of the product, the first set of requirements becomes redundant.

  2. #2
    The regulations are clear in that there is an expectation that the documents are retained, and of course available to inspectors upon request.

    However what are the expectations regarding archiving these documents? Obviously sponsors need to do a risk assessment and take some steps to ensure that documents are secure, protected against deterioration and possible damage due to vermin, fire or flood if that risk is likely. But are specific minimal archival requirements spelled out anywhere in the regulations?

  3. #3
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    Sponsor or owner "other documentation pertaining to the trial" are adequately listed:- "documentation shall include: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used; standard operating procedures; all written opinions on the protocol and procedures; the investigator’s brochure; case report forms on each trial subject; final report; audit certificate(s), if available." Therefore the documents in the first part would be "essential clinical trial documents" other than those mentioned above as sponsor other documentation. Typically the "essential clinical trial documents" are listed in ICH GCP E6 section 8. Therefore I would take it as being any and all of the TMF documents listed in section 8 apart from those listed as "other documentation" (which must be retained as long as the product is authorised). My best guess.

  4. #4
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    And of course, Volume 10 Chapter V Recommendations on the documentation consituting the Trial Master File, which lists "essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated." And of course, just like ICH GCP, lists these as retained at investigator site, sponsor or both. I would not take it that 2003/63/EC is refering exclusively to investigator site files when it says - "essential clinical trial documents (including case report forms) other than subject’s medical files, to be kept by the owners of the data". These would be both sponsor and investigator files not classified as "other documentation pertaining to the trial" which is adequately listed.

  5. #5
    The problem I have with this interpretation is that the Directive uses the phrase "all other documentation pertaining to the trial as long as the product is authorised. This documentation shall include: the protocol.... ". So the reference to documentation in this section includes ALL other documents not specifically mentioned elsewhere that pertain to the trial. The itemised list following are simply examples (hence the word "includes"). In fact the examples quoted also fall into the first category of documents that should be retained for 15 years or approval plus 2 years i.e. the two sections are not mutually exclusive. Furthermore, the Directive, ICH-GCP and Volume 10 makes it clear that the list of documents identified in ICH Chapter 8 is only a minimum list of essential documents. The MHRA have stated explicitly that they expect far more documents to be retained than are represented in this minimum list of essential documents e.g. those identified in the DIA TMF Reference Model. So, it is still not clear to me what documents fall into each of the two categories included in the Directive and why one category or core, essential documents needs to be retained for a shorter period of time than "all other documents pertaining to the trial".

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