Working with a CRO who won’t file ‘outside’ documents

Home Forums TMF Management, Content & Processing Working with a CRO who won’t file ‘outside’ documents

Viewing 3 reply threads
  • Author
    Posts
    • #3899
      Katie Kelly
      Participant

      Hi all,
      I am currently evaluating a CRO who will only commit to filing essential documents per GCP and will not file in the eTMF what they consider ‘outside documents’ (eg, vendor or IP documents). My organization does not have an internal eTMF.

      Has anyone come across this and how did you manage the documentation?

      Thank you!
      Katie

    • #3900
      Karen Roy
      Participant

      Hi Katie

      There are a number of slides that the MHRA have presented that support that section 8 is not sufficient. They may help – email me and I can send them. kroy@phlexglobal.com

      Karen

    • #3916
      Tina Belanger
      Participant

      Hi,

      I have run into this issue myself and would like to see the MHRA slides on section 8 as well. Would it be possible to receive them?

      Thanks so much!

      Tina

    • #3942
      Angela McCullagh
      Participant

      The MHRA GCP Q&A Forum include a whole section of FAQs on TMF management which include this topic. I would also refer to the EMA/INS/GCP/856758/2018 Guideline on the content, management and archiving of the clinical trial master file (paper and//or electronic), which specifically states (3.5.1) that GCP 8 should not be used as a definitive checklist and is not an exhaustive list.

Viewing 3 reply threads
  • You must be logged in to reply to this topic.