80 FR 36820 - Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 123 (June 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 123 (June 26, 2015)
| Page Range | 36820-36821 | |
| FR Document | 2015-15644 |
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)] [Notices] [Pages 36820-36821] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15644] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1887] Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Center for Drug Evaluation and Research (CDER) is interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties. DATES: Submit either electric or written requests for participation in the demonstration project by August 10, 2015. ADDRESSES: Submit written requests for single copies of the documents 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. Send one self-addressed adhesive label to assist that office in processing your requests. Submit electronic comments 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: Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301- 796-5333, ronald.fitzmartin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The information systems, as well as the underlying data models, that define both clinical care and clinical research are widely disparate. This was not an issue for the conduct of clinical research prior to use of EHRs or EDC because data were captured on paper case report forms. However, much has changed in the past decade for clinical research where EDC systems are now ubiquitous for the capture of clinical trials data. Similarly, EHRs have had widespread adoption and are rapidly becoming a standard part of clinical care. In 2013, FDA published a final guidance on ``Electronic Source Data in Clinical Investigations'' which encourages use of electronic source data in the conduct of clinical trials intended for inclusion in investigational and new drug applications. The electronic capture of data from EHRs and healthcare devices, such as electrocardiogram management systems, digital imaging and mobile health devices, as well as electronic Patient Reported Outcomes Instruments has the potential to improve the reliability, quality, traceability, provenance and integrity of data from electronic source to regulatory submission. Demonstration projects should assess and report value and challenges of the EHR-to-EDC single-point capture of source data in a clinical research environment. Streamlining clinical research at the source may open up opportunities to improve clinical trial design and execution, speed the cycle of clinical research and get medicines to market faster. Specifically, the use of a standards-based technology solution in clinical trials has the potential to:Eliminate duplication of data by capturing and transmitting electronic source data; auto-populate the electronic study forms from EHRs; reduce transcription errors and improve the quality of data; encourage entering source data at the point of care; facilitate remote monitoring of data to reduce the number of onsite visits by regulated biopharmaceutical industry; improve site monitoring to minimize the need for cross- reference data in multiple sources; make it easier for investigators to conduct clinical research; facilitate the inspection and reconstruction of clinical investigations by FDA; and [[Page 36821]] improve the standards-based technology solution to encourage widespread adoption. II. Questions to Stakeholders 1. What other potential benefits to stakeholders can be achieved through the use of a standards-based technology solution focusing on EHR and EDC integration? 2. What are the challenges to the implementation of a standards- based technology solution focusing on EHR and EDC integration? 3. What are the gaps between the data collected in a healthcare setting by EHRs vs. clinical research data required for regulated drug development? 4. Are there any perceived regulatory obstacles to the implementation of a standards-based technology solution focusing on EHR and EDC integration? (Examples include: Source data verification, remote monitoring, 21 CFR part 11, patient privacy, access control and confidentiality safeguards.) If yes, what approach(es) would you recommend to overcome these obstacles? 5. Are there any obstacles to the implementation of a standards- based technology solution focusing on EHR and EDC integration? 6. What standards-based solutions may exist? III. Requests for Response Comments, proposed approaches, interest to participate, and responses to the questions are to be identified with the docket number found in brackets in the heading of this document. Interested parties should include the following information in the request: Contact name, contact phone number, email address, name of the stakeholder, and address. Once requests for participation are received, FDA will contact interested stakeholders to discuss demonstration projects. The elapsed time duration of any project is expected to be approximately 12 months but may be extended as needed. Dated: June 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-15644 Filed 6-25-15; 8:45 am] BILLING CODE 4164-01-P
![36820 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
NIDILRR uses information submitted Dated: June 22, 2015. MD 20993–002, 301–796–5333,
by grantees as part of their Annual John Tschida, ronald.fitzmartin@fda.hhs.gov.
Performance Reports for these reviews. Director, National Institute on Disability, SUPPLEMENTARY INFORMATION:
5. Continuation Awards: In making a Independent Living, and Rehabilitation
Research. I. Background
continuation award, the Administrator
[FR Doc. 2015–15746 Filed 6–25–15; 8:45 am] The information systems, as well as
of the Administration for Community
BILLING CODE 4154–01–P the underlying data models, that define
Living may consider, under 45 CFR part
both clinical care and clinical research
75, the extent to which a grantee has
are widely disparate. This was not an
made ‘‘substantial progress toward DEPARTMENT OF HEALTH AND issue for the conduct of clinical research
meeting the objectives in its approved HUMAN SERVICES prior to use of EHRs or EDC because
application.’’ This consideration data were captured on paper case report
includes the review of a grantee’s Food and Drug Administration forms. However, much has changed in
progress in meeting the targets and the past decade for clinical research
[Docket No. FDA–2015–N–1887]
projected outcomes in its approved where EDC systems are now ubiquitous
application, and whether the grantee Source Data Capture From Electronic for the capture of clinical trials data.
has expended funds in a manner that is Health Records: Using Standardized Similarly, EHRs have had widespread
consistent with its approved application Clinical Research Data adoption and are rapidly becoming a
and budget. In making a continuation standard part of clinical care.
grant, the Administrator also considers AGENCY: Food and Drug Administration, In 2013, FDA published a final
whether the grantee is operating in HHS. guidance on ‘‘Electronic Source Data in
compliance with the assurances in its ACTION: Notice. Clinical Investigations’’ which
approved application, including those encourages use of electronic source data
SUMMARY: The Center for Drug in the conduct of clinical trials intended
applicable to Federal civil rights laws
Evaluation and Research (CDER) is for inclusion in investigational and new
that prohibit discrimination in programs
interested in supporting demonstration drug applications. The electronic
or activities receiving Federal financial projects to test the capability and
assistance from the Department. capture of data from EHRs and
evaluate performance of using an end- healthcare devices, such as
Continuation funding is also subject to to-end Electronic Health Record (EHR)-
availability of funds. electrocardiogram management systems,
to-Electronic Data Capture (EDC) single- digital imaging and mobile health
VII. Agency Contact point data capture approach, using devices, as well as electronic Patient
established data and implementation Reported Outcomes Instruments has the
FOR FURTHER INFORMATION CONTACT: standards in a regulated clinical potential to improve the reliability,
Patricia Barrett, U.S. Department of research environment. A demonstration quality, traceability, provenance and
Health and Human Services, 400 project should ideally test the use of a integrity of data from electronic source
Maryland Avenue SW., Room 5142, standards-based technology solution to to regulatory submission.
PCP, Washington, DC 20202–2700. enable the collection of related Demonstration projects should assess
Telephone: (202) 245–6211 or by email: healthcare and clinical research and report value and challenges of the
patricia.barrett@acl.hhs.gov. information within a single system and EHR-to-EDC single-point capture of
workflow. Stakeholders may include source data in a clinical research
If you use a TDD or a TTY, call the regulated industry, EHR and EDC
Federal Relay Service (FRS), toll free, at environment. Streamlining clinical
vendors, academic medical centers, and research at the source may open up
1–800–877–8339. other interested parties. opportunities to improve clinical trial
VIII. Other Information DATES: Submit either electric or written design and execution, speed the cycle of
requests for participation in the clinical research and get medicines to
Electronic Access to This Document: demonstration project by August 10, market faster.
The official version of this document is 2015. Specifically, the use of a standards-
the document published in the Federal based technology solution in clinical
ADDRESSES: Submit written requests for
Register. Free Internet access to the trials has the potential to:
single copies of the documents to the
official edition of the Federal Register
Division of Drug Information, Center for • Eliminate duplication of data by
and the Code of Federal Regulations is capturing and transmitting electronic
Drug Evaluation and Research, Food
available via the Federal Digital System and Drug Administration, 10903 New source data;
at: www.gpo.gov/fdsys. At this site you Hampshire Ave., Bldg. 51, Rm. 2201, • auto-populate the electronic study
can view this document, as well as all Silver Spring, MD 20993–0002. Send forms from EHRs;
other documents of this Department • reduce transcription errors and
one self-addressed adhesive label to
published in the Federal Register, in improve the quality of data;
assist that office in processing your • encourage entering source data at
text or Adobe Portable Document requests.
Format (PDF). To use PDF you must the point of care;
Submit electronic comments to • facilitate remote monitoring of data
have Adobe Acrobat Reader, which is http://www.regulations.gov. Submit
available free at the site. to reduce the number of onsite visits by
written comments to the Division of regulated biopharmaceutical industry;
You may also access documents of the Dockets Management (HFA–305), Food • improve site monitoring to
and Drug Administration, 5630 Fishers
tkelley on DSK3SPTVN1PROD with NOTICES
Department published in the Federal minimize the need for cross-reference
Register by using the article search Lane, Rm. 1061, Rockville, MD 20852. data in multiple sources;
feature at: www.federalregister.gov. FOR FURTHER INFORMATION CONTACT: Ron • make it easier for investigators to
Specifically, through the advanced Fitzmartin, Center for Drug Evaluation conduct clinical research;
search feature at this site, you can limit and Research, Food and Drug • facilitate the inspection and
your search to documents published by Administration, 10903 New Hampshire reconstruction of clinical investigations
the Department. Ave., Bldg. 51, Rm. 1192, Silver Spring, by FDA; and
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![Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices 36821
• improve the standards-based DEPARTMENT OF HEALTH AND found in brackets in the heading of this
technology solution to encourage HUMAN SERVICES document.
widespread adoption. FOR FURTHER INFORMATION CONTACT: UDI
Food and Drug Administration Regulatory Policy Support, Center for
II. Questions to Stakeholders
[Docket No. FDA–2015–D–2245] Devices and Radiological Health, Food
1. What other potential benefits to and Drug Administration, 10903 New
stakeholders can be achieved through Unique Device Identification: Direct Hampshire Ave., Bldg. 66, Rm. 3303,
the use of a standards-based technology Marking of Devices; Draft Guidance for Silver Spring, MD 20993–0002, 301–
solution focusing on EHR and EDC Industry and Food and Drug 796–5995, email: GUDIDSupport@
integration? Administration Staff; Availability and fda.hhs.gov.
Request for Comments SUPPLEMENTARY INFORMATION:
2. What are the challenges to the
implementation of a standards-based AGENCY: Food and Drug Administration, I. Background
technology solution focusing on EHR HHS.
Section 226 of the Food and Drug
and EDC integration? ACTION: Notice. Administration Amendments Act of
3. What are the gaps between the data SUMMARY: The Food and Drug 2007 and section 614 of the Food and
collected in a healthcare setting by Administration (FDA) is announcing the Drug Administration Safety and
EHRs vs. clinical research data required availability of the draft guidance Innovation Act amended the Federal
for regulated drug development? entitled ‘‘Unique Device Identification: Food, Drug, and Cosmetic Act to add
4. Are there any perceived regulatory Direct Marking of Devices.’’ Direct section 519(f) (21 U.S.C. 360i(f)), which
marking is an important feature of directs FDA to issue regulations
obstacles to the implementation of a
FDA’s unique device identification establishing a unique device
standards-based technology solution
system. This document is intended to identification system for medical
focusing on EHR and EDC integration?
assist industry and FDA staff to devices along with implementation
(Examples include: Source data timeframes for certain medical devices.
verification, remote monitoring, 21 CFR understand FDA’s requirements for
direct marking of devices with a unique The unique device identification system
part 11, patient privacy, access control final rule was published on September
and confidentiality safeguards.) If yes, device identifier (UDI). In addition, FDA
is seeking information on what 24, 2013 (78 FR 58786) (the UDI Rule).
what approach(es) would you 21 CFR 801.45 requires a device bear
processes should be considered to meet
recommend to overcome these a permanent UDI marking if the device
the definition of ‘‘reprocessing’’ for
obstacles? is intended to be used more than once
purposes of UDI direct marking
5. Are there any obstacles to the requirements. and intended to be reprocessed before
implementation of a standards-based each use. It details the UDI format when
DATES: Although you can comment on provided as a direct marking, and
technology solution focusing on EHR
any guidance at any time (see 21 CFR provides criteria for exceptions to this
and EDC integration? 10.115(g)(5)), to ensure that the Agency UDI direct marking requirement. As
6. What standards-based solutions considers your comments on this draft explained in the preamble of the UDI
may exist? guidance before it begins work on the Rule, UDI direct marking requirements
final version of the guidance, submit apply to devices that are intended to be
III. Requests for Response
either electronic or written comments used for months or years, sometimes
Comments, proposed approaches, on the draft guidance by September 24, many years. Because such devices are
interest to participate, and responses to 2015. intended to be reprocessed and reused,
the questions are to be identified with ADDRESSES: An electronic copy of the they will inevitably be separated from
the docket number found in brackets in draft guidance document is available for their original labels and device
the heading of this document. Interested download from the Internet. See the packages. UDI direct marking helps to
parties should include the following SUPPLEMENTARY INFORMATION section for ensure the adequate identification of
information in the request: Contact information on electronic access to the such devices through their distribution
name, contact phone number, email draft guidance. Submit written requests and use. However, the UDI Rule does
address, name of the stakeholder, and for a single hard copy of the draft not define ‘‘intended to be used more
address. Once requests for participation guidance document entitled ‘‘Unique than once’’ and ‘‘reprocessed.’’ FDA’s
are received, FDA will contact Device Identification: Direct Marking of interpretation of these terms is included
Devices’’ to the Office of the Center in this draft guidance, but FDA seeks
interested stakeholders to discuss
Director, Guidance and Policy additional information on its current
demonstration projects. The elapsed
Development, Center for Devices and definition of ‘‘reprocessing’’ for
time duration of any project is expected Radiological Health, Food and Drug purposes of UDI direct marking
to be approximately 12 months but may Administration, 10903 New Hampshire requirements.
be extended as needed. Ave., Bldg. 66, Rm. 5431, Silver Spring, FDA guidance entitled ‘‘Reprocessing
Dated: June 22, 2015. MD 20993–0002. Send one self- Medical Devices in Health Care Settings:
Leslie Kux, addressed adhesive label to assist that Validation Methods and Labeling;
Associate Commissioner for Policy. office in processing your request. Guidance for Industry and Food and
Submit electronic comments on the Drug Administration Staff’’ issued on
[FR Doc. 2015–15644 Filed 6–25–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
draft guidance to http:// March 17, 2015 (available at http://
BILLING CODE 4164–01–P
www.regulations.gov. Submit written www.fda.gov/downloads/
comments to the Division of Dockets MedicalDevices/
Management (HFA–305), Food and Drug DeviceRegulationandGuidance/
Administration, 5630 Fishers Lane, Rm. GuidanceDocuments/UCM253010.pdf)
1061, Rockville, MD 20852. Identify (the Reprocessing Guidance), indicates
comments with the docket number that reprocessing of reusable devices
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Document Created: 2015-12-15 14:15:20
Document Modified: 2015-12-15 14:15:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electric or written requests for participation in the demonstration project by August 10, 2015. | |
| Contact | Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301- 796-5333, [email protected] | |
| FR Citation | 80 FR 36820 |
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