The on Guidance on the topic was first issued in 2001 but since then clinical research and outsourcing have evolved. Revisions to the document cover industry shifts and technological advances, such as the rise of electronic records, but the focus and goals of the document remain unchanged.
“These regulations establish specific responsibilities of sponsors for ensuring the proper conduct of clinical studies for submission to FDA (US Food and Drug Administration) and the protection of the rights and welfare of subjects involved in clinical studies”, says the guidance.
While retaining this focus the FDA compliance program guidance manual (CPGM) for sponsors, contract research organisations (CRO), and monitors has been revised with the addition of new sections and deletion of others.
For instance, electronic records and signatures are now covered by the guidance. Although this is new the goal is unchanged, with regulatory requirements staying the same “whether clinical data are captured on paper, electronically, or using a hybrid approach”.
Submission of information to ClinicalTrials.gov is another change. Inspectors must now determine if studies were registered on ClinicalTrials.gov, who entered the information, and whether primary and secondary outcome measures are listed.
Clinical trials are increasingly conducted outside the US and the FDA guidance accounts for this change. Overseas trials must be compliant with good clinical practice (GCP), says the guidance, and the FDA must be able to validate data through an on-site inspection if deemed necessary.
Globalization has advanced alongside multisite trials and both are addressed by the guidance. “With the prevalence of multisite clinical trials, traditional monitoring techniques – early and frequent on-site visits at all clinical sites – have become resource intensive”, says the guidance.
Other areas addressed by the guidance include: what to do when fraud is suspected; financial disclosure from investigators; and how to investigate whether emergency research followed guidelines.