
[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69632-69633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Electronic Source Data in Clinical 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availability of a draft guidance for industry entitled ``Electronic 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updates the draft guidance entitled ``Electronic Source Documentation 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, contract research organizations (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 The revised draft guidance promotes 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.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that FDA considers your comment on the revised 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance within January 22, 2013.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance to the Division of Drug Information, Center for Drug 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; 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448; Division of Small 
Manufacturers, International and 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; 
and Office of Critical Path Programs, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4173, 
Silver Spring,

[[Page 69633]]

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 draft 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: Ronald Fitzmartin, Office of Planning 
and Informatics, 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    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.
    In the Federal Register of January 7, 2011 (76 FR 1173), FDA 
announced the availability of the draft guidance entitled ``Electronic 
Source Documentation in Clinical Investigations.'' Based on public 
comment, we have revised the January 2011 draft guidance to clarify a 
number of points made by industry. The Agency is publishing the draft 
guidance as a revised draft guidance to collect additional public 
comments. 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. The draft 
guidance discusses the following topics related to electronic source 
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.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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

    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 Sec. Sec.  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), Federal Register Notice of Availability 
of that guidance. The capture, review, and archiving of electronic 
source data, as described in the draft 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: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28198 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P


