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Regulatory Update, August 1025

Saturday, August 1, 2015

FDA seeks help from stakeholders on direct electronic source data to EDC

In the June 26, 2015 Federal Register, the Food and Drug Administration’s (FDA) Cen­ter for Drug Evaluation and Research (CDER) announced it 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/EDC vendors, academic medical centers, and other interested parties.

Information systems and the underlying data models that define both clinical care and clinical research are widely disparate. This was not an issue for 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” encouraging use of electronic source data in the conduct of clinical trials intended for inclusion in investigational/new drug applica­tions. The electronic capture of data from EHRs and healthcare devices (e.g., 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
  • improve the standards-based technology solution to encourage widespread adoption.

CDER posed the following questions for stakeholders:

  1. What other potential benefits to stakehold­ers can be achieved through the use of a standards-based technology solution focus­ing on EHR/EDC integration?
  2. What are the challenges to the implementa­tion of a standards-based technology solu­tion focusing on EHR/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/EDC integration? (e.g., 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/EDC integration?
  6. What standards-based solutions may exist?

Submissions, including comments, pro­posed approaches, interest to participate, and responses to the questions are invited. Interested parties should provide the follow­ing information in the submission: 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.

Submissions may be electronic or writ­ten and send to FDA by August 10, 2015. Electronic submissions should be made to www.regulations.gov and written submis­sions should be made to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Identify them with Docket No. FDA-2015-N-1887.


The Regulatory Update is excerpted from Research Practitioner, Volume 16, Number 4, July-August 2015.

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