Transcelerate Docs

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    • #2857
      Paula Stallings
      Participant

      Hi,
      Has anyone had experience with receiving TMF documents that were previously used in Transcelerate (e.g., CVs Training records)? We have received some of these documents from sites and they have the information of previous studies or sponsors on them. I would usually advise to never have other sponsor or study information in a TMF, but has anyone else had experience with this now that many sites are using Transcelerate?

    • #2858
      Martina Duevel
      Participant

      Hi Paula,
      in the Shared Investigator Platform (SIP) which was developed by TransCelerate registered site staff have to create a CV or perform a general training only once. The respective records are shared between all sponsors on the platform.
      This is to reduce the burden for the sites which are working in studies from different sponsors. For GCP training a mutual recognition process is in place and the certificates are downloaded for the TMFs as needed
      To my knowledge to date more than 40000 site useres are registrered in SIP

    • #2859
      Eldin Rammell
      Participant

      The SIP initiative from TransCelerate is a great attempt at introducing efficiency. However, from Paula’s query it seems that some investigator’s are adding sponsor-specific details to their common documents in the portal. This breaches confidentiality if those same documents are shared with other sponsors. The CVs uploaded to the SIP by the investigator should not make reference to sponsors for whom they are or have conducted trials for, unless that information is in the public domain e.g. as part of a list of publications on the CV.

      Perhaps consider asking that the investigator to replace the CV with one that does not reveal the identity of trial sponsors?

    • #2860
      Martina Duevel
      Participant

      Thanks Eldin, absolutely!

    • #2861
      Paula Stallings
      Participant

      Hi and thank you both for the feedback.

      Eldin you are correct. The issue is with study specific information being included on documents. We have had several instances with training records that contained the names of the previous sponsor or study (such as CVs and GCP training).

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