TMF – Studies not under the IND or CTA

Home Forums General Discussion Forum TMF – Studies not under the IND or CTA

Viewing 2 reply threads
  • Author
    Posts
    • #3044
      Alonso Blanco
      Participant

      is a TMF required for studies not under the IND or CTA? This is part of a compassionate use program which does not fall into the study category and is likely exempt.

    • #3045
      Eldin Rammell
      Participant

      There is usually a requirement to retain study-specific records for any type of clinical study, including those that are not regulated by Good Clinical Practice requirements (and therefore, not specific TMF requirements). So the set of documents are likely to be much smaller than for an IND/CTA clinical trial and it may not be referred to a “a TMF”, but you’ll still need to retain documentary evidence of what you have done. The TMF Reference Model Project has a sub-team that is developing a reduced Reference Model for this type of study, with many of the artifacts being advisory in the absence of specific global regulatory requirements.

    • #3046
      Alonso Blanco
      Participant

      Thank you Eldin, your input is highly appreciated.

Viewing 2 reply threads
  • You must be logged in to reply to this topic.