7 January 2010

[Federal Register: January 7, 2011 (Volume 76, Number 5)]
[Notices]               
[Page 1173-1174]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja11-67]                         

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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Draft Guidance for Industry on Electronic Source Documentation in 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availability of a draft guidance for industry entitled ``Electronic 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 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10.115(g)(5)), to ensure that FDA considers your comments on the draft 
guidance before it begins work on the final version of the guidance, 
submit electronic or written comments on the draft guidance by April 7, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Critical Path Programs, Office of the 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://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 Submit written comments on the draft guidance to 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:
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    \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.
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     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 Sec. Sec.  312.62(b) and 312.64(b) have 
been approved under OMB control number 0910-0014; and the collection of 
information in Sec. Sec.  812.140 and 812.150 has been approved under 
OMB control number 0910-0078.

[[Page 1174]]

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.
[FR Doc. 2011-73 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P