Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability, 57395-57396 [2013-22645]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
industry entitled ‘‘Patient Counseling
Information Section of Labeling for
Human Prescription Drug and Biological
Products—Content and Format.’’ The
recommendations in the draft guidance
are intended to help ensure that the
labeling is clear, useful, informative,
and to the extent possible, consistent in
content and format.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 18,
2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the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, or the
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. 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for electronic access to the draft
guidance document.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
draft guidance to https://www.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:
Jonas Santiago, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6358,
Silver Spring, MD 20993–0002, 301–
796–5346; or Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
how to present information within the
section, and how to format and organize
section contents.
This guidance is one of a series of
guidances FDA is developing, or has
developed, to assist applicants with the
content and format of the labeling for
human prescription drug and biological
products. In the Federal Register of
January 24, 2006 (71 FR 3922), FDA
published a final rule on labeling for
human prescription drug and biological
products. The final rule and additional
guidances can be accessed at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/Laws
ActsandRules/ucm084159.htm. The
labeling requirements and these
guidances are intended to make
information in prescription drug
labeling easier for health care
practitioners to access, read, and use.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance represents the
Agency’s current thinking on the
content and format of the ‘‘Patient
Counseling Information’’ section of
labeling for human prescription drug
and biological products. 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.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Patient Counseling Information Section
of Labeling for Human Prescription
Drug and Biological Products—Content
and Format.’’ This draft guidance
provides recommendations for the
‘‘Patient Counseling Information’’
section on the following: How to decide
what topics to include in the section,
This draft guidance also 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 201.56 and
201.57 have been approved under OMB
control number 0910–0572.
VerDate Mar<15>2010
16:45 Sep 17, 2013
Jkt 229001
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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. The Paperwork Reduction Act of
1995
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
57395
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm or https://www.
regulations.gov.
Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22644 Filed 9–17–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0643]
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 guidance for industry
entitled ‘‘Electronic Source Data in
Clinical Investigations.’’ This document
provides guidance to sponsors, contract
research organizations (CROs), clinical
investigators, and others involved in the
capture, review, and retention of
electronic source data in FDA-regulated
clinical investigations. This guidance
promotes capturing source data in
electronic form, and it is intended to
assist in ensuring the reliability, quality,
integrity, and traceability of data from
electronic source to electronic
regulatory submission.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this 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, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448 (the
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800); or the Division of Small
Manufacturers, International and
SUMMARY:
E:\FR\FM\18SEN1.SGM
18SEN1
57396
Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Notices
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. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the 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: Ron
Fitzmartin, 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; or
Jonathan Helfgott, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5369,
Silver Spring, MD 20993–0002, 301–
796–5636.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK67QTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Electronic Source Data in Clinical
Investigations.’’ This document
provides guidance to sponsors, CROs,
clinical investigators, and others
involved in the capture, review, and
retention of electronic source data in
FDA-regulated clinical investigations.
This guidance promotes capturing
source data in electronic form, and it is
intended to assist in ensuring the
reliability, quality, integrity, and
traceability of data from electronic
source to electronic regulatory
submission.
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, but are not limited to,
clinical data initially recorded in
electronic health records maintained by
healthcare providers and institutions,
electronic laboratory reports, electronic
medical images from devices, and
electronic diaries completed by study
subjects.
Capturing source data electronically
and transmitting it to the electronic case
report form (eCRF) should help to: (1)
Eliminate unnecessary duplication of
data; (2) reduce the possibility for
transcription errors; (3) encourage
entering source data during a subject’s
visit, where appropriate; (4) eliminate
VerDate Mar<15>2010
16:45 Sep 17, 2013
Jkt 229001
transcription of source data prior to
entry into an eCRF; (5) facilitate remote
monitoring of data; (6) promote realtime access for data review; and (7)
facilitate the collection of accurate and
complete data.
In the Federal Register of November
20, 2012 (77 FR 69632), FDA issued a
draft version of this guidance entitled
‘‘Electronic Source Data in Clinical
Investigations.’’ The comment period on
the draft guidance ended on March 26,
2013 (see the correction notice of
December 26, 2012 (77 FR 76049)). Most
of the comments sought clarification on
the topics discussed in the guidance.
We have reviewed all comments
received on the draft guidance. As a
result of the public comments, we have
clarified the following sections of the
guidance: I. Introduction, II.
Background, III. Electronic Source Data
(and its subsections), and IV. Use and
Description of Computerized Systems in
Clinical Investigations. We have also
updated the Glossary definitions, added
a References section, and added
reference citations throughout the
guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the Agency’s
current thinking on the capture, review,
and retention of electronic source 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
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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
This 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). This
guidance pertains to sponsors, clinical
investigators, CROs, and others involved
in the capture, review, and retention of
PO 00000
Frm 00046
Fmt 4703
Sfmt 9990
electronic source data in FDA-regulated
clinical investigations and who send
certain information to FDA or others, or
who keep certain records and make
them available to FDA inspectors. The
information collection discussed in the
guidance is contained in our
investigational new drug regulations in
part 312 (21 CFR part 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 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 guidance, is discussed in the May
10, 2007 (72 FR 26638), Federal
Register Notice of Availability of that
guidance. The capture, review, and
retention of electronic source data, as
described in this 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/
GuidanceComplianceR
egulatoryInformation/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: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22645 Filed 9–17–13; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57395-57396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22645]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0643]
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 guidance for industry entitled ``Electronic Source
Data in Clinical Investigations.'' This document provides guidance to
sponsors, contract research organizations (CROs), clinical
investigators, and others involved in the capture, review, and
retention of electronic source data in FDA-regulated clinical
investigations. This guidance promotes capturing source data in
electronic form, and it is intended to assist in ensuring the
reliability, quality, integrity, and traceability of data from
electronic source to electronic regulatory submission.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this 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, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448 (the guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800); or the Division of Small Manufacturers, International and
[[Page 57396]]
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. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the 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: Ron Fitzmartin, 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; or Jonathan Helfgott, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 5369, Silver Spring, MD 20993-0002, 301-796-5636.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Electronic Source Data in Clinical Investigations.'' This
document provides guidance to sponsors, CROs, clinical investigators,
and others involved in the capture, review, and retention of electronic
source data in FDA-regulated clinical investigations. This guidance
promotes capturing source data in electronic form, and it is intended
to assist in ensuring the reliability, quality, integrity, and
traceability of data from electronic source to electronic regulatory
submission.
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, but are not limited to,
clinical data initially recorded in electronic health records
maintained by healthcare providers and institutions, electronic
laboratory reports, electronic medical images from devices, and
electronic diaries completed by study subjects.
Capturing source data electronically and transmitting it to the
electronic case report form (eCRF) should help to: (1) Eliminate
unnecessary duplication of data; (2) reduce the possibility for
transcription errors; (3) encourage entering source data during a
subject's visit, where appropriate; (4) eliminate transcription of
source data prior to entry into an eCRF; (5) facilitate remote
monitoring of data; (6) promote real-time access for data review; and
(7) facilitate the collection of accurate and complete data.
In the Federal Register of November 20, 2012 (77 FR 69632), FDA
issued a draft version of this guidance entitled ``Electronic Source
Data in Clinical Investigations.'' The comment period on the draft
guidance ended on March 26, 2013 (see the correction notice of December
26, 2012 (77 FR 76049)). Most of the comments sought clarification on
the topics discussed in the guidance. We have reviewed all comments
received on the draft guidance. As a result of the public comments, we
have clarified the following sections of the guidance: I. Introduction,
II. Background, III. Electronic Source Data (and its subsections), and
IV. Use and Description of Computerized Systems in Clinical
Investigations. We have also updated the Glossary definitions, added a
References section, and added reference citations throughout the
guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
Agency's current thinking on the capture, review, and retention of
electronic source 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 electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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
This 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). This guidance
pertains to sponsors, clinical investigators, CROs, and others involved
in the capture, review, and retention of electronic source data in FDA-
regulated clinical investigations and who send certain information to
FDA or others, or who keep certain records and make them available to
FDA inspectors. The information collection discussed in the guidance is
contained in our investigational new drug regulations in part 312 (21
CFR part 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
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
guidance, is discussed in the May 10, 2007 (72 FR 26638), Federal
Register Notice of Availability of that guidance. The capture, review,
and retention of electronic source data, as described in this 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: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22645 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P
