Good Clinical Practice Q&As

摘要

As described in the joint guidance, during inspections of clinical study sites, FDA requires access to records and reports made by the investigator, including site-specific versions or electronic informed consent (eIC) materials submitted to IRBs for review and approval, all amendments to the site-specific eICs, and all subject-specific signed eICs. These should be available at the site either in electronic or paper form. FDA reserves the right to review the content of the informed consent program or document and the corresponding consent of the subject, the subject’s LAR, and a witness, where applicable, along with the date that the eIC was signed. Any updates to the documentation should also be available for review.