Department of Health and Human Services May 10, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Guidance for Industry on Computerized Systems Used in Clinical Investigations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Computerized Systems Used in Clinical Investigations,'' dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation, i.e., electronic records. This guidance supersedes the guidance entitled ``Computerized Systems Used in Clinical Trials,'' dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled ``Part 11, Electronic Records; Electronic SignaturesScope and Application,'' dated August 2003, and FDA's international harmonization efforts when applying guidance to source data generated at clinical study sites.
Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects-Supervisory Responsibilities of Investigators; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Protecting the Rights, Safety, and Welfare of Study SubjectsSupervisory Responsibilities of Investigators.'' This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The draft guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.
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