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FDA is announcing the availability of a draft guidance for industry entitled “Electronic Source Data in Clinical Investigations.” This document revises and updates the draft guidance entitled “Electronic Source Documentation in Clinical Investigations.” This revised draft document provides guidance to sponsors, CROs, data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.
With the use of computerized systems for capturing clinical study data, it is common to find at least some source data recorded electronically. Common examples include clinical data initially recorded in electronic health records maintained by hospitals and institutions, electronic laboratory reports, electronic medical images from devices, and electronic diaries provided by study subjects.
Capturing source data electronically should help to: (1) Eliminate unnecessary duplication of data; (2) reduce the possibility for transcription errors; (3) encourage entering source data at the time of a subject's visit; (4) eliminate transcribing source data before entering the data into an electronic data capture system; (5) promote real-time data access for review; and (6) ensure the accuracy and completeness of the data.
• Identifying and specifying authorized source data originators;
• Creating data element identifiers to facilitate sponsors, FDA, and other authorized parties in examining the audit trail of data;
• Capturing source data into the eCRF using either manual or electronic capture methods; and
• Investigator responsibilities with respect to reviewing and retaining electronic data.
The revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CDR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
The draft guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The draft guidance pertains to sponsors, clinical investigators, contract research organizations, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations and who send certain information to FDA or others, or keep certain records and make them available to FDA inspectors. The information collection discussed in the draft guidance is contained in our investigational new drug regulations (21 CFR 312) and approved under OMB control number 0910-0014, including §§ 312.62(b) and 312.58(a). In addition, the collection of information in 21 CFR part 11, as discussed in the draft guidance, is approved under OMB control number 0910-0303. OMB approval of the information collection in the guidance entitled “Computerized Systems Used in Clinical Investigations,” as mentioned in the draft guidance, is discussed in the May 10, 2007 (72 FR 26638),
Persons with access to the Internet may obtain the document at