[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57395-57396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0643]


Guidance for Industry on Electronic Source Data in Clinical 
Investigations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Electronic Source 
Data in Clinical Investigations.'' This document provides guidance to 
sponsors, contract research organizations (CROs), clinical 
investigators, and others involved in the capture, review, and 
retention of electronic source data in FDA-regulated clinical 
investigations. This guidance promotes capturing source data in 
electronic form, and it is intended to assist in ensuring the 
reliability, quality, integrity, and traceability of data from 
electronic source to electronic regulatory submission.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002, or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448 (the guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800); or the Division of Small Manufacturers, International and

[[Page 57396]]

Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1160, Silver Spring, MD 20993-0002, 301-
796-5333; or Jonathan Helfgott, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 5369, Silver Spring, MD 20993-0002, 301-796-5636.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Electronic Source Data in Clinical Investigations.'' This 
document provides guidance to sponsors, CROs, clinical investigators, 
and others involved in the capture, review, and retention of electronic 
source data in FDA-regulated clinical investigations. This guidance 
promotes capturing source data in electronic form, and it is intended 
to assist in ensuring the reliability, quality, integrity, and 
traceability of data from electronic source to electronic regulatory 
submission.
    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, but are not limited to, 
clinical data initially recorded in electronic health records 
maintained by healthcare providers and institutions, electronic 
laboratory reports, electronic medical images from devices, and 
electronic diaries completed by study subjects.
    Capturing source data electronically and transmitting it to the 
electronic case report form (eCRF) should help to: (1) Eliminate 
unnecessary duplication of data; (2) reduce the possibility for 
transcription errors; (3) encourage entering source data during a 
subject's visit, where appropriate; (4) eliminate transcription of 
source data prior to entry into an eCRF; (5) facilitate remote 
monitoring of data; (6) promote real-time access for data review; and 
(7) facilitate the collection of accurate and complete data.
    In the Federal Register of November 20, 2012 (77 FR 69632), FDA 
issued a draft version of this guidance entitled ``Electronic Source 
Data in Clinical Investigations.'' The comment period on the draft 
guidance ended on March 26, 2013 (see the correction notice of December 
26, 2012 (77 FR 76049)). Most of the comments sought clarification on 
the topics discussed in the guidance. We have reviewed all comments 
received on the draft guidance. As a result of the public comments, we 
have clarified the following sections of the guidance: I. Introduction, 
II. Background, III. Electronic Source Data (and its subsections), and 
IV. Use and Description of Computerized Systems in Clinical 
Investigations. We have also updated the Glossary definitions, added a 
References section, and added reference citations throughout the 
guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
Agency's current thinking on the capture, review, and retention of 
electronic source 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This 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). This guidance 
pertains to sponsors, clinical investigators, CROs, and others involved 
in the capture, review, and retention of electronic source data in FDA-
regulated clinical investigations and who send certain information to 
FDA or others, or who keep certain records and make them available to 
FDA inspectors. The information collection discussed in the guidance is 
contained in our investigational new drug regulations in part 312 (21 
CFR part 312) and approved under OMB control number 0910-0014, 
including Sec. Sec.  312.62(b) and 312.58(a). In addition, the 
collection of information in 21 CFR part 11, as discussed in the 
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 
guidance, is discussed in the May 10, 2007 (72 FR 26638), Federal 
Register Notice of Availability of that guidance. The capture, review, 
and retention of electronic source data, as described in this guidance, 
would not result in any new costs, including capital costs or operating 
and maintenance costs, because sponsors and others already have and are 
experienced with using the computer-based equipment and software 
necessary to be consistent with the guidance.

IV. Electronic Access

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

    Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22645 Filed 9-17-13; 8:45 am]
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