5 FDA & GCP Must Read Documents for All Clinical Researchers

Clinical researchers are constantly faced with new and changing guidelines, rules and regulations. Now is a great time to refresh yourself on GCP and FDA guidelines, as well as understanding any new FDA guidelines that were released or updated in the past year. We have compiled several important documents discussing FDA and GCP guidelines and regulations that serve as a great refresher for everybody working on clinical trials. We have also provided updated documents about regulations that have been added or updated this year.

Refresher Items

Guidelines for Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

“Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects” provides an overview of the responsibilities of any person who conducts a clinical investigation of a drug, biological product, or medical device. The goal of this document is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations.

Electronic Source Data in Clinical Investigations

This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this document promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

New or Updated Items

Informed Consent Information Sheet

This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations. This guidance, when finalized, will supersede “A Guide to Informed Consent,” issued in September 1998, by the Office of Health Affairs, FDA. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research.

Humanitarian Device Exemption (HDE): Questions and Answers

This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 613 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 9, 2012, amended section 520(m) of the FD&C Act. This guidance document also reflects changes in the HDE program resulting from FDASIA.

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