[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36820-36821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15644]


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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.

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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, [email protected].

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