Essential documents Deep Dive: informed consent tracking Hart’s Good Clinical Practice glossary series


Essential documents Deep Dive: informed consent tracking Hart’s Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure and clinical protocol/protocol amendments in this portion of our glossary series.


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Informed consent is a broad subject and we will be covering the why, what, and how of the informed consent process in future posts of our medical ethics series (additional ethics topics here and here). Today’s glossary post is about managing the informed consent document as an essential document in the trial master file (TMF).

A full history of the life of a study informed consent should be available in the TMF.  This means at a minimum, for each IRB/EC approved informed consent, the TMF should contain:

  • The version that was submitted to the site coordinator, with his or her changes tracked,
  • The version submitted to the IRB, and all submission documentation,
  • Any versions that went back and forth with the IRB/EC, with tracked changes and all correspondence between the IRB/EC and site during that process,
  • IRB/EC approval documents with the stamped and approved version of the consent, and all correspondence related to that approval.

Every change to an informed consent version should have a unique identifying name and date of revision, whether it is a draft prior to submission to the IRB/EC or during their review, or if it is a stamped and approved versions that can be used to consent patients into a trial.

The more organized and better labeled your informed consent files are, the easier it will be to find pieces of documentation in the future when an auditor is asking for them! 

Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at advertisements used during a trial.

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