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  1. #1
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    Dec 2011

    End of Study Definition for Archiving

    What is considered to be an appropriate time point at which the trial is considered to have ended and access to TMF documents should be restricted to named individuals? The legislation (SI 2006/1928 and European guidance on TMF and archiving) does not state a time interval.

  2. #2
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    Nov 2011
    Access the TMF in order to add or remove documentation should be controlled. So in that sense access is controlled and restricted at all times before, during and after a trial. However when to restrict access so that only an archivist can have direct access , as you say, is not explicitly stated, but a risk-adapted approach might be useful. Having controls in place for placing or removing documentation from the TMF whilst the trial is in progress would be a good idea. The TMF must be kept up to date, regulation 31A(3) of SI 2004/1031 states that ‘The master file shall at all times contain the essential documents relating to that clinical trial’. TMFs after the trial has completed should be ‘complete and legible’ (regulation 31A(7) of SI 2004/1031). There should be a process to ensure that any changes to documents in the TMF are traceable regulation 31A(6) of SI 2004/1031.

  3. #3
    Just one additional comment: Guidance document ENTR/F2/BL D(2003) from the European Commission states " When is the end of the trial? The definition of the end of the trial should be provided in the protocol and any change to this definition for whatever reason should be notified as a substantial amendment. In most cases it will be the date of the last visit of the last patient undergoing the trial. Any exceptions to this should be justified in the protocol." As mentioned, the regulations and guidance do not define when is an appropriate time to transfer essential records to the archive but this must be defined in your SOPs in relation to the end of the trial or, as is more commonly the case, in relation to the completion of the study report (for which specific timelines are set in the regulations).

    MHRA comment: CT1 03 2010 is the latest version. The definition of EOT in art 43 remains the same.
    Last edited by MHRA Moderator; 3rd Aug 2012 at 07:33 AM.

  4. #4
    access so that only an archivist can have direct access , as you say, is not explicitly stated, but a risk-adapted approach might be useful

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