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Thread: Shadow TMF requirements

  1. #1
    Forum Member
    Join Date
    Nov 2011
    Chippenham, Wiltshire

    Talking Shadow TMF requirements

    I work for a sponsor company and we contract CRO's to run our clinical studies and Trial Master Files.
    We run a shadow TMF for each study, which so far has been handled well.
    We are starting more and more studies and I feel the way we run the shadow TMF's is no longer efficient. I am working with our CTA to streamline the process, however as there are no published requirements for a shadow TMF, we are all struggling to agree on what documents need to be filed.
    We currently save all documents and correspondence electronically and print everything to file in our archive. We feel this is too much; just electronic files could suffice as the CRO runs the main TMF for us.
    Does anyone have any experience of running a shadow TMF and what do you keep in it?
    What do you feel are key documents that need to be printed for inclusion in a paper shadow TMF?

    Thank you

  2. #2
    I have some experience of the problem described, both as a sponsor records manager and also as a consultant for clients. Typically, sponsors attempt to replicate as much as possible in their shadow TMF. However, much of the content has little immediate value to the sponsor, gives the sponsor a major maintenance burden and according to the regulations, is not necessary. The approach that I recommend has two strands to it. Firstly, make it 100% clear in your agreements, delegation of responsibilities log, responsibilities matrix etc that responsibility for maintenance of the sponsor TMF has been delegated to the CRO. In other words, if you have an inspection, it is the TMF maintained by the CRO that contains the "official record". Secondly, identify the minimum TMF content that you need to see in order to provide the necessary oversight of the study and of the CRO. This will provide the MAXIMUM content of your shadow TMF. From this list however, there may be documents that you need to see/review but do not necessarily need to retain. I would recommend identifying those that you could add to a "Document Review Log". Your process then would be to receive a copy of the document, review its content, make an appropriate entry on the Document Review Log, and then destroy the copy. You would only retain a copy of those documents that you need to refer back to. Finally, I would actually suggest not referring to your files as "shadow TMF" files. Just a minor point but subconsciously, people then tend to give the files more importance than they actually bear. The CRO is maintaining the TMF on your behalf. I would call your files "Sponsor Project Managememnt" or "Project Oversight" files. This avoids any potential confusion with the "actual" TMF. The bottom line is that you are outsourcing study conduct to make efficient use of resources; it is therefore a backward step if you duplicate what the CRO is doing with regards to document management.

    I would add a caveat to the above. For practical reasons, you may wish to retain the master copy of some documents if they are being generated internally. Keep these in a separate file.... rightly called "the TMF". Your documentation should clearly show that some TMF content is maintained by the sponsor and the rest by the CRO.

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