Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability, 69632-69633 [2012-28198]

Download as PDF wreier-aviles on DSK5TPTVN1PROD with 69632 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices products in determining that the proposed research satisfies the criteria for approval contained in 21 CFR 56.111, that ‘‘* * * the risks to subjects are minimized * * * and reasonable in relation to anticipated benefits, if any, to subjects * * *.’’ In particular, the guidance addresses the IRB’s role in reviewing: (1) The qualifications of investigators, (2) the adequacy of the research site, and (3) the determination of whether an IND/IDE is needed. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance entitled ‘‘Institutional Review Boards Frequently Asked Questions— Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.’’ 1 FDA is issuing this as a draft guidance. Although many of these recommendations have appeared in other FDA guidance documents, FDA has compiled the information here in order to assure that all IRBs are aware of and have access to it. The guidance also explains how IRBs may efficiently fulfill these important responsibilities. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts and in consultation with OHRP. In addition, FDA acknowledges HHS’s publication of the advanced notice of proposed rulemaking (ANPRM), ‘‘Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,’’ in the Federal Register of July 26, 2011 (76 FR 44512). In the ANPRM, HHS sought comment on whether the Federal human subject protection regulations should be modified in a number of ways. In finalizing this draft guidance, ‘‘IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed,’’ FDA intends to consider relevant public comments submitted in response to both the draft guidance and the ANPRM. The draft guidance is being issued consistent with FDA’s Good Guidance Practices (GGPs) regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current 1 See https://www.fda.gov/RegulatoryInformation/ Guidances/ucm126420.htm#GeneralQuestions. VerDate Mar<15>2010 15:12 Nov 19, 2012 Jkt 229001 thinking on this topic. 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. The Paperwork Reduction Act of 1995 This draft guidance includes information collections provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501–3520). The collections of information referenced in this guidance that are related to IRB recordkeeping requirements under 21 CFR 56.115 have been approved under OMB control number 0910–0130; the collections of information under 21 CFR Part 312 have been approved under OMB control number 0910–0014; and the collections of information under 21 CFR Part 812 have been approved under OMB control number 0910–0078. In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to these previously approved collections of information found in FDA regulations. III. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// 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. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/ScienceResearch/Special Topics/RunningClinicalTrials/ ProposedRegulationsand DraftGuidances/default.htm or https:// www.regulations.gov. Dated: November 15, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–28149 Filed 11–19–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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. 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, SUMMARY: E:\FR\FM\20NON1.SGM 20NON1 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices MD 20993–0002. Send one selfaddressed 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 https://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: wreier-aviles on DSK5TPTVN1PROD with 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 VerDate Mar<15>2010 15:12 Nov 19, 2012 Jkt 229001 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 FDAregulated 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 https:// 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 https:// 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 69633 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 §§ 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 computerbased equipment and software necessary to be consistent with the guidance. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, https://www.fda.gov/Regulatory Information/Guidances/default.htm, or https://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 E:\FR\FM\20NON1.SGM 20NON1

Agencies

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://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 https://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
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, or https://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

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