EMA's Expectations for updated Investigator's Brochures and Informed Consent Forms

EMA's GCP Inspectors Working Group added a new Question & Answer No. 19 relating to IBs and ICFs in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As.

What are the expectations for distribution of updated Investigator's Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites / investigators?

  • Investigator's Brochures: An IB with substantial changes should be distributed to clinical sites/ investigators as soon as it has been approved by the competent authority. It is not acceptable to wait until the updated IB has been approved in all EU Member States (MSs) or worldwide, or approved for all clinical trials concerned, before distributing it to the clinical sites/ investigators already covered by an approval. However, sponsors should wait for approval of the IB in all MSs before starting to use the updated Reference Safety Information (RSI). 

  • Informed Consent Forms: A revised ICF should be distributed to clinical sites/ investigators as soon as it has received a favourable opinion from the ethics committee and is approved by the competent authority. An unjustified substantial delay (e.g. several weeks), which affects patients’ rights, between the favourable opinion/ approval and the distribution is considered unacceptable. Cases where an outdated ICF missing important new information was signed by a participant at enrolment, or a delay to obtain re-consent to participate in a trial on a new ICF, are considered GCP non-compliance, i.e. the trial participant was not (adequately) informed.

For more information please see EMA's Q&A: Good clinical practice (GCP).

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