Good Clinical Practice Guide
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Thread: Transfer of sponsor

  1. #1

    Transfer of sponsor

    If a sponsor transfers the responsibility for study to another sponsor part way through an ongoing trial, what documents should the original sponsor expect to have in the TMF at the time of transfer?

  2. #2
    Regulations require that the TMF is maintained contemporaneously and should be inspection ready at all times. Therefore the sponsor TMF should be hold all records generated to date at the time of transfer to the new sponsor.

  3. #3
    Forum Member
    Join Date
    Nov 2011
    Or is the question; what should the original sponsor retain after shipping the TMF to the new sponsor? Needs thinking about but the question is whether the original sponsor can have ready access to the TMF in case of inspection so that they can show that the carried out their legal duties as a sponsor (including oversight by the sponsor) up to and including transfer to a new sponsor. Your Legal and insurance departments and regulatory affairs departments should be consulted to ensure that you can have your documentation readily available in case of any questions or inspection. It might be a good idea to have a "shadow" copy of the TMF so that you do know that the TMF will be readily available and accessible by you at all times. Remember that any vendors and CROs that you used should also make sure that they can access the TMF which is now transferred. Your oversight documentation of those vendors and CROs should be part of the TMF. Also you may have a legal duty to inform the regulatory authorities that sponsorship has changed. There may be other legal, ethical and regulatory concerns. Making sure that investigators and ethics committees are informed of the change. RQA ( answered a question about informing the subjects that there is a change in sponsorship.

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