The deadline for completing the ICF GCP R3 certification for the remaining members of the study team is extended until January 31, 2026. The Agency understands the needs of some sponsors in terms of the training of all members of the study teams and their availability, so that in this way they will have enough time to fulfill the required training and obtain the certificate, which will ensure compliance with the standards of Good Clinical Practice.
As principal investigators lead study teams and assume responsibilities under the new guideline, they must be trained on ICH GCP R3 by the end of 2025.