Guidance for Industry on Computerized Systems Used in Clinical Investigations; Availability, 26638-26639 [E7-9056]

Download as PDF 26638 Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). There are no other changes to the meeting. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: May 7, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–9053 Filed 5–9–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D–0440] Guidance for Industry on Computerized Systems Used in Clinical Investigations; Availability AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Computerized Systems Used in Clinical Investigations,’’ dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation, i.e., electronic records. This guidance supersedes the guidance entitled ‘‘Computerized Systems Used in Clinical Trials,’’ dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled ‘‘Part 11, Electronic Records; Electronic Signatures—Scope and Application,’’ dated August 2003, and FDA’s international harmonization efforts when applying guidance to source data generated at clinical study sites. VerDate Aug<31>2005 15:04 May 09, 2007 Jkt 211001 Submit written or electronic comments on agency guidance at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Office of Critical Path Programs (HF– 18), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit phone requests to 800–835–4709 or 301–827–1800. Submit written comments on the guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Patricia M. Beers Block, Good Clinical Practice Program (HF–34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 3340. SUPPLEMENTARY INFORMATION: DATES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Computerized Systems Used in Clinical Investigations.’’ This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. There is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject. Such source data and source documentation must meet certain fundamental elements of data quality, e.g., attributable, legible, contemporaneous, original, and accurate, that are expected of paper records. FDA’s acceptance of data from clinical trials for decisionmaking purposes depends on FDA’s ability to verify the quality and integrity of the data during FDA onsite inspections and audits. In the Federal Register of October 4, 2004 (69 FR 59239), FDA announced the availability of the draft guidance entitled ‘‘Computerized Systems Used in Clinical Trials,’’ dated September 2004. FDA considered the comments submitted to the docket in revising this guidance. This guidance supersedes the guidance of the same title dated April 1999; finalizes the draft guidance dated September 2004; and supplements the PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 guidance for industry entitled ‘‘Part 11, Electronic Records; Electronic Signatures—Scope and Application,’’ dated August 2003, and FDA’s international harmonization efforts when applying guidance to source data generated at clinical study sites. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on computerized systems used in 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. The Paperwork Reduction Act of 1995 This 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 21 CFR part 11 have been approved under OMB Control No. 0910–0303. The collections of information in 21 CFR 312.62 have been approved under OMB Control No. 0910–0014. The collections of information in 21 CFR 511.1(b)(7)(ii) have been approved under OMB Control No. 0910–0117. The collections of information in 21 CFR 812.140 have been approved under OMB Control No. 0910–0078. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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 either https://www.fda.gov/oc/gcp or https:// www.fda.gov/ohrms/dockets/ default.htm. E:\FR\FM\10MYN1.SGM 10MYN1 Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices Dated: May 4, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–9056 Filed 5–9–07; 8:45 am] Path Programs (HF–18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7864. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–S I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators.’’ Under the regulations in part 312 (21 CFR part 312) (Investigational New Drug Application) and part 812 (21 CFR part 812) (Investigational Device Exemptions), an investigator is responsible for ensuring that a clinical investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the control of drugs, biological products, and devices under investigation (§§ 312.60 and 812.100). This draft guidance clarifies the responsibilities of investigators in the conduct of clinical investigations conducted under parts 312 and 812, particularly the responsibilities to supervise the conduct of the clinical investigation, and to protect the rights, safety, and welfare of study participants in drug, biologic, and medical device clinical trials. The draft guidance also provides recommendations on how investigators should supervise the study-related actions of persons not in the direct employ of the investigator, including certain study staff and parties conducting associated testing and assessments. This 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 the supervisory responsibilities of investigators. 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0173] Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects— Supervisory Responsibilities of Investigators; Availability AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Protecting the Rights, Safety, and Welfare of Study Subjects— Supervisory Responsibilities of Investigators.’’ This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The draft guidance also clarifies FDA’s expectations concerning the investigator’s responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties. DATES: Submit written or electronic comments on the draft guidance by July 9, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Critical Path Programs (HF– 18), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit telephone requests to 800–835– 4709 or 301–827–1800. 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. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of Critical VerDate Aug<31>2005 15:04 May 09, 2007 Jkt 211001 II. The 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 part 312 have been approved under OMB Control No. 0910– 0014; and the collections of information PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 26639 in part 812 have been approved under OMB Control No. 0910–0078. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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 either https://www.fda.gov/cder/guidance/ index.htm orhttps://www.fda.gov/ohrms/ dockets/default.htm. Dated: May 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–9055 Filed 5–9–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)–443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Women’s Physical Activity and Healthy Eating Tools Assessment: NEW The HRSA Office of Women’s Health (OWH) developed the Bright Futures for Women’s Health and Wellness (BFWHW) Initiative to help expand the scope of women’s preventive health activities, particularly related to nutrition and physical activity. An intermediate assessment of the BFWHW E:\FR\FM\10MYN1.SGM 10MYN1

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[Federal Register Volume 72, Number 90 (Thursday, May 10, 2007)]
[Notices]
[Pages 26638-26639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9056]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0440]


Guidance for Industry on Computerized Systems Used 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 guidance for industry entitled ``Computerized Systems 
Used in Clinical Investigations,'' dated May 2007. This document 
provides to sponsors, contract research organizations, data management 
centers, clinical investigators, and institutional review boards, 
recommendations regarding the use of computerized systems in clinical 
investigations. Because the source data in source documentation are 
necessary for the reconstruction and evaluation of the trial to 
determine the safety and effectiveness of new human and animal drugs, 
and medical devices, this guidance is intended to assist in ensuring 
confidence in the reliability, quality, and integrity of electronic 
source data and source documentation, i.e., electronic records. This 
guidance supersedes the guidance entitled ``Computerized Systems Used 
in Clinical Trials,'' dated April 1999; finalizes the draft guidance of 
the same title dated September 2004; and supplements the guidance for 
industry entitled ``Part 11, Electronic Records; Electronic 
Signatures--Scope and Application,'' dated August 2003, and FDA's 
international harmonization efforts when applying guidance to source 
data generated at clinical study sites.

DATES:  Submit written or electronic comments on agency guidance at any 
time.

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Office of Critical Path Programs (HF-18), Office of the 
Commissioner, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit phone requests to 800-
835-4709 or 301-827-1800. Submit written comments on the guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to https://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT:  Patricia M. Beers Block, Good 
Clinical Practice Program (HF-34), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Computerized Systems Used in Clinical Investigations.'' This 
document provides to sponsors, contract research organizations, data 
management centers, clinical investigators, and institutional review 
boards, recommendations regarding the use of computerized systems in 
clinical investigations. There is an increasing use of computerized 
systems in clinical trials to generate and maintain source data and 
source documentation on each clinical trial subject. Such source data 
and source documentation must meet certain fundamental elements of data 
quality, e.g., attributable, legible, contemporaneous, original, and 
accurate, that are expected of paper records. FDA's acceptance of data 
from clinical trials for decisionmaking purposes depends on FDA's 
ability to verify the quality and integrity of the data during FDA 
onsite inspections and audits.
    In the Federal Register of October 4, 2004 (69 FR 59239), FDA 
announced the availability of the draft guidance entitled 
``Computerized Systems Used in Clinical Trials,'' dated September 2004. 
FDA considered the comments submitted to the docket in revising this 
guidance. This guidance supersedes the guidance of the same title dated 
April 1999; finalizes the draft guidance dated September 2004; and 
supplements the guidance for industry entitled ``Part 11, Electronic 
Records; Electronic Signatures--Scope and Application,'' dated August 
2003, and FDA's international harmonization efforts when applying 
guidance to source data generated at clinical study sites.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on computerized systems used in 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. The Paperwork Reduction Act of 1995

    This 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 21 CFR part 11 have been approved under 
OMB Control No. 0910-0303. The collections of information in 21 CFR 
312.62 have been approved under OMB Control No. 0910-0014. The 
collections of information in 21 CFR 511.1(b)(7)(ii) have been approved 
under OMB Control No. 0910-0117. The collections of information in 21 
CFR 812.140 have been approved under OMB Control No. 0910-0078.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding this document. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified 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 
either https://www.fda.gov/oc/gcp or https://www.fda.gov/ohrms/dockets/
default.htm.


[[Page 26639]]


    Dated: May 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9056 Filed 5-9-07; 8:45 am]
BILLING CODE 4160-01-S

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