On November 20, the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials. 77 Fed. Reg. 69,631-69,633 (Nov. 20, 2012).

Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the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

The first draft guidance is intended to assist institutional review boards (IRBs), investigators, and sponsors in determining that the criteria for IRB approval of research are satisfied. The key consideration is whether the risks to subjects are minimized and reasonable in relation to anticipated benefits. The draft discusses the IRB’s role in reviewing (1) the qualifications of the clinical investigator; (2) the adequacy of the facility in which the research will take place; and (3) the determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) application is necessary for the proposed investigation.

When finalized, the guidance will supersede part of FDA’s January 1998 guidance entitled “Institutional Review Boards Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.” It consolidates and clarifies previously provided advice. Interested parties should submit comments on the draft guidance by January 22, 2013.

Draft Guidance for Industry: Electronic Source Data in Clinical Investigations

The second draft guidance addresses some of the difficult issues that arise when electronic source data are used in clinical trials. It is intended to provide guidance to sponsors, contract research organizations (CROs), data management centers, and investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It addresses the reliability, quality, integrity, and traceability of electronic source data.

The draft addresses comments received on an earlier version and attempts to respond to concerns about FDA’s understanding of technology used in clinical trials. FDA explained that, “This revised draft guidance addresses source data (from clinical investigations) used to fill the predefined fields in an electronic case report form (eCRF), according to protocol,” as well as the following topics related to electronic source data: (1) identifying and specifying authorized source data originators; (2) creating data element identifiers to facilitate sponsor, 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. Interested parties should submit comments on the draft guidance by January 22, 2013.

The draft guidances are available at: