The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in determining whether the proposed research satisfies the criteria for IRB approval. Specifically, the guidance addresses the IRB’s role in reviewing: (1) the qualifications of investigators; (2) the adequacy of research sites; and (3) the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed. Many of the recommendations in the guidance have appeared in other FDA guidance documents or have been communicated to IRBs who have contacted the agency directly about these issues, but FDA has compiled the information here to ensure that all IRBs are aware of and have access to it. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance Institutional Review Board Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.
The second draft guidance, Draft Guidance for Industry: Electronic Source Data in Clinical Investigations, provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This guidance revises and updates the draft guidance Electronic Source Documentation in Clinical Investigations. The draft guidance addresses source data (from clinical investigations) used to fill the predefined fields in an electronic case report form (eCRF), according to protocol , and discusses the following topics related to electronic source data: (1) identifying and specifying authorized source data originators; (2) creating data element identifiers to facilitate sponsors, FDA, and other authorized parties in examining the audit trail of data; (3) capturing source data into the eCRF using either manual or electronic capture methods; and (4) investigator responsibilities with respect to reviewing and retaining electronic data. Comments on both guidance documents will be accepted at www.regulations.gov until January 22, 2013.