Good Clinical Practice Guide
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Thread: Database and TMF

  1. #1

    Database and TMF

    Should a clinical trial Database be included into the TMF at completion of a study? It is an essential document to show how the trial was managed but ICH makes no reference to Clinical Databases in E6 and I cannot find a reference to the requirement to add the DB to the TMF and archive it.

    Many thanks,


  2. #2
    To help clairfy expectation, please see a response from the MHRA:

    The documentation referred to in the ICH guidance will form part of the TMF, but will not necessarily form the entire TMF i.e. the list provided in Section 8 is not exhaustive. Consideration should be given to Regulation 31A (4) of the UK Clinical Trial Regulations:

    The essential documents relating to a clinical trial are those which –
    a) Enable both the conduct of the clinical trial and the quality of the data produced to be evaluated

    Also, (Regulation 31A (3)):

    The Trial Master File (TMF) shall at all times contain the essential documents relating to that trial.

    It is not an expectation that a clinical trial database becomes part of any TMF. However the database is a key component of any clinical trial so consideration must be given to the database being essential to retain, and to allow the data management activities conducted in the database functionality to be evaluated as per compliance with the GCP principle (Regulation 28, Schedule 1, Part 2, 4) “The necessary procedures to secure the quality of every aspect of the trial shall be complied with.”

    The key documentation that support the quality of the data within the database are essential documents relating to the clinical trial and, as such, must be stored within the TMF. Sufficient documentation must be retained to enable reconstruction of the study and assessment of the conduct of the trial. For example (not an exhaustive list), these types of documents relating to the database would include, database build/testing/approval, relevant Quality Assurance/Quality Control, database lock/unlock approvals, relevant correspondence, and records of archiving.

    Data files retained should allow the reconstruction or redeployment of the database if needed and data and metadata should be available as datasets as an absolute minimum, flat pdfs (i.e. with no supporting metadata) are not acceptable at all.

    The MHRA will inspect all aspects of the database including the retained essential documents in the TMF and the database itself, which includes the clinical data and all the metadata (audit trails etc.). Direct (and guided) access to the database should be made available along with the TMF for inspection.

    MHRA Moderator

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