2011-73. Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Electronic Source Documentation in Clinical Investigations.” This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA's recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by April 7, 2011.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Critical Path Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4173, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Leonard Sacks, Office of Critical Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 32, rm. 4174, Silver Spring, MD 20993-0002, 301-796-8502.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Electronic Source Documentation in Clinical Investigations.” This guidance is intended to be used together with the guidances for industry ^[1] entitled:

• Computerized Systems Used in Clinical Investigations,
• Part 11, Electronic Records; Electronic Signatures—Scope and Application, and
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

With the increasing use of computerized systems in clinical investigations, it is common to find source data documented in an electronic format, e.g., clinical data initially documented in electronic health records maintained by hospitals and institutions, electronic case report forms, laboratory reports that are electronically generated, electronic medical images from devices, and electronic diaries provided by study subjects. When paper source documents are available for review, tracing of data in paper-based studies can be performed easily. However, when source data is electronic, the data is traced through complex data capture, transmission, and archival processes. This guidance recommends practices that will help ensure that electronic source data and source records are accurate, legible, original, attributable (e.g., user name and password), and contemporaneously entered; and meet the regulatory requirements for recordkeeping and retention.

The following specific topics related to electronic source data are discussed:

• The identification of the data element as the basic unit of information in the electronic case report form;
• The description of a source of each data element;
• Information about the electronic creation, modification, transmission, and storage of source data and documents;
• Investigator responsibilities with respect to reviewing and archiving electronic data;
• Transmission of the data to the sponsor and/or other designated parties; and
• Preservation of data integrity.

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 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.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in §§ 312.62(b) and 312.64(b) have been approved under OMB control number 0910-0014; and the collection of information in §§ 812.140 and 812.150 has been approved under OMB control number 0910-0078.

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm,, http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm,, and http://www.regulations.gov.

Dated: January 1, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

Footnotes

1.  FDA guidances are available on FDA's Web page at http://www.fda.gov/​RegulatoryInformation/​Guidances/​default.htm. FDA guidances are issued and updated regularly. We recommend you check the Web site to ensure that you have the most up-to-date version of a guidance.