[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69632-69633]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Electronic Source Data in Clinical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availability of a draft guidance for industry entitled ``Electronic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updates the draft guidance entitled ``Electronic Source Documentation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 The revised draft guidance promotes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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance within January 22, 2013.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draft guidance to the Division of Drug Information, Center for Drug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]
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