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Thread: TMF Index

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  1. #1
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    TMF Index

    Does MHRA provide any requirements on how the TMF Index (TMF Table Of Contents) should look like. I mean what information should be captured in the TMF Index. Currently in our organization (A Pharmaceutical Company), the TMF Index comprises of a table with three columns. First column documents the section numbers of the TMF, second column shows the title of the document to be filed in that section and the third column states whether the document is actually filed or not. Can anyone suggest if this format of TMF Index is adequate for Trials conducted in UK.

  2. #2
    The regulations pertaining to the TMF (MHRA and other Regulatory agencies) do not provide any specific requirements for the TMF Index. However, what you have descrtibed sounds very typical of the TMF Indexes that I have seen and that would most likely be considerd to be acceptable.

    To my knowledge, there is actually no specific requirement for a TMF Index. The regulations do require an index to the archive in order to keep a record of all TMFs that have been submitted to the archive and to track retrievals from the archive. It is usually considered sufficient to record the trial number and not for the index to record the detailed contents of the files.

    HOWEVER, the primary regulatory requirement that relates to this query is that essential documents must be "readily available upon request" and "can be retrieved upon the request of a regulatory authority". This requirement is usually interpreted to mean that some kind of index is required to facilitate the rapid and accurate retrieval of specific documents. Indeed, there are numerous GCP inspection findings related to the inability of the sponsor to locate documents that have been requested. You therefore simply need to have assurance that your index allows you to rapidly and accurately find TMF content. The requirements apply equally to paper TMFs and electronic TMFs.

  3. #3
    The following MHRA Moderator comment is provided in relation to the comments about archiving above:
    The UK Clinical Trial Regulations (SI 2004 No. 1031, as amended) don't go into detail about records relating to archiving. However, it is important that the sponsor maintains records of the trials conducted and the archive arrangements for the TMF for those trials, particularly if the organisation sponsors many trials and an external archive facility is being used. Removal of the records from the archive is anticipated to be a relatively rare occurrence and the records should track documentation to and from the archive facility (particularly important where contract archives are being used) and, where appropriate, such as, for large organisations, location of the documentation on site when temporarily removed from the archive. The process should be controlled or overseen by the named individual responsible for archiving.

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