Using Standardized Clinical Research Data
The Center for Drug Evaluation and Research (CDER) encourages seamless exchange of structured, re-usable information between health care and clinical research systems so that data may be entered once at the point of care and used many times without manual re-entry or manual source data verification. In September 2013, FDA published the Electronic Source Data in Clinical Investigations guidance promoting the need for capturing source data in electronic form including data originated in health care systems. To achieve this goal, CDER is interested in fostering collaboration of regulated industry, EHR and Electronic Data Capture (EDC) vendors, academic medical centers, and Standards Development Organizations (SDOs) and other parties. On June 26, 2015, the Center published a notice entitled Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data in the Federal Register (Vol. 80:123, June 26, 2015). The purpose of this notice is to elicit demonstration projects to test and evaluate performance of end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approaches in a standards-based, regulated clinical research environment. Ideally, these projects would test standards-based technology solutions for collection of related healthcare and clinical research information. Proposed solutions were not required to use a particular set of standards or technology. In response to the FR notice, CDER received 41 proposals from stakeholders that included regulated industry, EHR and EDC vendors, standards development organizations and academic medical centers.
On July 07, 2015, CDER conducted a Webinar: Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data (July 7, 2015) supporting demonstration projects to test the capability and performance of end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approaches that use established data and implementation standards in a regulated clinical research environment. CDER is encouraging these demonstration projects as well as bringing together interested parties to collaborate with each other. We look forward to the initiation of demonstration projects as soon as feasible and sharing technologies and standards outcomes in this forum.
The following six questions were posed to stakeholders in both the FR notice and the webinar:
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?
Proposed Demonstration Solutions
Table 1 summarizes proposed solutions of various stakeholders as submitted to the Federal Register docket focused on Source Data Capture from Electronic Health Records: Using Standards Clinical Research Data.
Table 1: Summary of Organizations and Proposed Demonstration Solutions
Demonstrate interoperability between their EDC system, Medidata Rave, and an EHR system using the Integrating the Healthcare Enterprise (IHE) Retrieve Form for Data Capture (RFD) profile.
Wombat, A scalable, open source technical solution, based on the mediator pattern.
Health Level Seven International (HL7)
Leveraging HL7 Fast Healthcare Interoperability Resources (FHIR) data standards and other standards such as Structured Data Capture (SDC) to encapsulate and transfer relevant data from the EHR to the EDC systems.
Society for Clinical Data Management (SCDM)
The Society proposes to be a consulting resource for organizations participating in the EHR to Electronic Data Capture demonstration.
OmniComm Systems, Inc.
Leverage OmniComm’s TrialMaster EDC product along with their suite of related clinical technologies (e.g., data management review capabilities, auto-encoding tools, Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) import listener and ODM import capability).
Adaptive Clinical Systems
Adaptive Clinical and its Health Care System Partner will demonstrate the impact to clinical research and health care delivery of implementing a standards-based integration platform (Adaptive eClinical BUS®), an interoperability platform.
Union Chemique Belge (UCB)
UCB, CDISC and Medidata propose to leverage the CDISC Healthcare Link initiative to enable the collection of related healthcare and clinical research information.
Duke Clinical Research Institute (DCRI) GlaxoSmithKline (GSK)
DCRI and GSK will leverage PopMedNet network portal infrastructure for the HARMONY-Outcomes clinical trial to demonstrate how EHR data can be organized into a query-able format to facilitate data acquisition.
GSK is interested in a demonstration project in collaboration with DCRI.
Clinical Trial Exchange Inc. (CTX)
CTX is developing a scalable, easy-to-use web-based solution that automates and streamlines data exchange and accurately transforms clinical trials data into a compatible format for pharmaceutical companies, clinical research organizations, (CROs), government registries, and the FDA in collaboration with a Uro-Oncology CRO.
Regenstrief National Center for Medical Device Informatics (REMEDI)
REMEDI is collecting medical device data (e.g., infusion pump alerts/alarms, infusion pump drug libraries, physiological monitors) along with electronic health records (EHR) from partnering hospital systems and is interested in a demonstration project.
Revon Systems LLC Baystate Health TechSpring
Revon Systems LLC and Baystate Health TechSpring will work together to design and implement technology systems that integrate data from both EHR and EDC data stores into a unified and normalized view of patient state and history.
HL7 Japan Hamamatsu University
HL7 Japan is proposing to leverage SS-MIX, a standardized storage that stores HL7 messages of prescriptions, lab results, and disease classifications, without database engine, and regardless of Hospital Information System (HIS) vendor.
Association of Clinical Research Organizations (ACRO)
Provides a description of a viable standards-based option for system integration.
MERCK Research Laboratories
Interested in a demonstration project.
Cerner, an EHR vendor, proposes the use of the HL7 Fast Healthcare Interoperability Resources (FHIR) specification in a demonstration project.
Pfizer is actively engaged in exploring eSource efforts with other research partners and through the industry collaboration of Transcelerate Biopharma LLC.
ImproveCareNow has created EHR-based data collection forms that allow for the discrete capture of the IBD-specific registry variables like disease phenotype and remission status.
Clinical Ink is proposing capturing source data at the research sites using the SureSource application running on tablets at the sites.
Flow Health Inc.
Utilize Flow Health's platform and tools including Patient Check-In and Guide to integrate EDC and EHR data at the GBMC Cancer Institute into a single end-to-end data system.
Novartis Pharmaceuticals Corporation
Novartis is proposing to leverage Digital Integrated Clinical Enterprise (DICE) platform architecture to simulate the integration of an EHR on an EDC in a clinical research study.
Nextrials is proposing to conduct a demonstration project in collaboration with PRA Health Sciences that leverages CDISC and IHE standards.
Electronic Record Services (ERS)
ERS is proposing to leverage EHR systems with an International Organization for Standardization (ISO) Electronic Health Record Communication Standard (EN13606) supportive interface, or use ISO EN13606 as persistence architecture and collaborate with Roche and Medidata.
Brigham and Women’s Hospital
Proposes to leverage the EPIC Care EHR system and standards such as HL7 FHIR and Substitutable Medical Apps Reusable Technologies (SMART) platform architecture on FHIR.
Yale School of Medicine Epic Corporation
Proposes to leverage EPIC and OnCore solutions and SDC profile focusing on adverse event reporting from EHRs.
College of American Pathologists (CAP)
CAP proposes to enable the FDA to adopt a new data entry forms (DEF-centric) standard for use in EHR and laboratory information management systems (LIMS). The DEF architectural model is Structured Data Capture (SDC), which is an initiative of the Office of the National Coordinator for Health Information Technology (ONC).
A team of clinical, document, and security experts working at the Advanced Technology Development Center at the Georgia Institute of Technology is interested in a demonstration project.
National Eye Institute (NEI)
NEI is working with Emmes Corporation to achieve automated transfer of data from their EHR system to their electronic data capture system (Advantage EDCSM).
Oracle Health Sciences
Oracle Health Sciences is interested in participating in a demonstration project.
Medpace is interested in leveraging ClinTrak EDC for integration of EDC and EHRs.
North Shore University Health System
North Shore will focus on discrete data capture tools in the EMR it has developed that are fully embedded in the workflow of physicians via Epic.
Target Health Inc.
Target Health Inc. is an eCRO interested in a participating in a demonstration project.
Mediparency is proposing a patient shared database under the patient 'data custodian' model.
IMR Technology is proposing a Cloud-based EHR solution.
Federation of American Societies for Experimental Biology (FASEB)
FASEB proposes to leverage Informatics for Integrating Biology and the Bedside (i2b2) platform as a potential vehicle for data integration.
Duke Office of Research Informatics (ORI) and CDISC
These parties will leverage a clinical research study at Duke, EPIC EHR system and RFD (Retrieve Form for Data Capture), for the collection of healthcare and clinical research information at the point of care.
This company is offering to serve as subject matter expert in ODM.
Interested in participating in a demonstration project.
Sam Miller is proposing to leverage EPAST an Electronic Patient and Study Tracker for the integration of EHRs and clinical research.
Interested in a demonstration project, where the body of work can be conducted off-shore.
Clinical Data Interchange Standards (CDISC)
Interested in 3 demonstration projects leveraging CDISC, IHE and HL7 standards in collaboration with Medidata, UCB and Duke ORI.
For additional details on a proposed demonstration project, please download: Demonstrations Project (XLS)
Questions Comments or Concerns
Questions regarding this FRN should be forwarded to: CDERDataStandards@fda.hhs.gov