This article was written by Shannon Roznoski of Advarra and Mike Buckley of the Memorial Sloan Kettering Cancer Center
The importance of technology’s role in transforming clinical data management practices cannot be understated in the COVID-19 pandemic. Now more than ever, technologies like eSource provide stable connectivity that increases data exchange quality by providing secure, scalable, and near-real time exchange of clinical trial data. Compared to traditional methods of data exchange, eSource technology enables sites and industry partners to be more resilient in the face of pandemic and other future threats. Moreover, eSource ensures the protection of data transfer pipelines during such threats, and enables continued secure data flows that are critical for evaluating downstream patient outcomes and decisions.
During the webinar “How Sites and Sponsors are Collaborating to Move eSource Forward”, eSource subject matter experts shared the current state of eSource collaborations between sites and sponsors, how the Society for Clinical Data Management (SCDM) eSource Implementation Consortium is bringing sites and sponsors together, gave an overview of the landscape of industry groups and initiatives focused on eSource, and how other organizations can get involved to help move the needle forward for eSource adoption and implementation.
After they discussed their experience as members of the SCDM eSource Implementation Consortium, the panelists received questions in three main areas:
- What are eSource and structured data transfers using Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR)?
- How is patient data protected in accordance with HIPAA and other regulatory requirements when eSource HL7 FHIR is utilized?
- What is the SCDM eSource Implementation Consortium, how can organizations join, and what benefits are there to be a member?
What is eSource and how is it utilized?
Per the US FDA, eSource is the initial recording of the source data in electronic format. Per TransCelerate Biopharma, Inc., eSource can be categorized under the four modalities – electronic health records (EHR), devices and apps, direct data capture (DDC) and non-case report form (CRF) sources. The webinar covered how eSource is a way of collecting data in electronic format that is located in a site’s source system (e.g. EHR, lab information system, etc.). That source data is ported from the site source system to the sponsor electronic data capture (EDC) or Data Management system using a variety of methods. There are many ways to exchange data from eSource. Sites and sponsors can utilize secure file transfer protocols (SFTP) to exchange data files via DDC, or they can use HL7 FHIR. Transfer methods are not limited to these two types of examples, but they are the most common.
What is structured data and why is it preferred for use in eSource?
Source data systems, such as a site’s EHR, lab information system, etc. are able to capture patient information that use structured and controlled ontologies. Data captured under these structured ontologies in clinical research are typically encountered with the following: encoded lab values, patient encounters, medication lists, response criteria, demographics, vitals, adverse events, etc. Understanding what data elements are structured, clinically adjudicated, and ready for transposition from the site source to an external system (EDC) and/or repository is a crucial step for prioritizing integration efforts that support automated eSource data exchanges. The common data model harmonization (CDMH) FHIR Implementation Guide focuses on mapping and translating these types of structured data into FHIR format.
What is Health Level Seven (HL7) and Fast Healthcare Interoperability Resources (FHIR)?
FHIR is an interoperability standard. It is meant to facilitate the exchange of healthcare information across the healthcare ecosystem (patients, providers, caregivers, researchers, payers, etc.). It’s defined by 1) a content model that is defined by resources, and 2) a specification for the exchange of that resource. For more background on HL7, FHIR, and Resources, please see the following resources:
- HL7 Product Brief
- FHIR Specification
- FHIR Resource List: Views by Category, Maturity Level, Security Category, etc.
This is what the SCDM eSource Implementation Consortium is focused on – leveraging existing HL7 FHIR standards to harmonize data exchange efforts across the clinical research enterprise.
How is patient data protected/secured in accordance with HIPAA and other regulatory/compliance considerations?
Security of patient data is paramount. For example, at Memorial Sloan Kettering Cancer Center, we are committed to protecting the privacy and information we gather about patients while providing health-related services. To this end, we leverage state of the art web authentication techniques recommended in the FHIR specification. Additionally, our information security team and clinical research informatics and technology team conduct joint vulnerability discovery and testing that includes but is not limited to the following: authentication, session management, access controls, error handling, input validation and injection, and cross site scripting. This discovery testing assessment is used to stress test the intended design and workflow described for the eSource HL7 FHIR data transfers. The output of these tests is a robust risk profile that considers complexity, information classification, exposure, maturity and capability, management control, vendor attributes, operational impact/criticality, and reputational impact.
For more information on authentication and authorization per protocol/clinical trial, we’d like to point to our documentation.
For each site that follows the FHIR standard approach to security, each sponsor will maintain the specific security information necessary to make each FHIR resource call to retrieve patient data from the site’s source data system (this is often, but not always the EHR, or the sites FHIR server). While it may be burdensome to have to track this for each site, keep in mind that the maps from each site’s source data system to the sponsor’s target data system (usually an Electronic Data Capture system) will also need to be maintained including the notion of the underlying terminology implemented in each site’s source data systems. Tracking the security information for each site’s source data systems will be trivial compared to the rest of the information necessary to track for each site. However, the resulting savings in data entry is well worth the time and effort for the activity.
There are so many different EDCs, so how will eSource work with each system?
We believe that standards are the key to successfully interfacing across multiple systems. This is the beauty of an organization such as the SCDM eSource Implementation Consortium. By bringing together stakeholders from across the industry to participate in projects and provide input to other industry initiatives we can develop, adopt, and improve upon standards so they are robust, widely adopted within the industry, and meet the needs of sites, sponsors, technology vendors and others. The HL7 FHIR standard is one that has been the focus of much interest in data exchange from site EHRs to sponsor EDCs. Groups such as the SCDM eSource Implementation Consortium are working with others within the industry to promote the development of research specific FHIR resources. As these resources mature, more organizations will be able to adopt these standards for data exchange.
What is the SCDM eSource Implementation Consortium, how can organizations join, and what benefits are there to becoming a member?
The SCDM eSource Implementation Consortium is a professional network bringing together academia and biopharmaceutical companies along with EHR vendors, EDC vendors and technology providers, establishing methods of clinical trial data transfer, define best practices that can be scaled up across the clinical research enterprise, and consistently share progress with the FDA Center for Drug Evaluation and Research (CDER) Health Information Technology (IT) Board, and other regulatory authorities. The consortium is dedicated to enabling faster and more efficient digital exchange of clinical research source data from academic medical sites to industry sponsors.
The SCDM eSource Implementation Consortium is free to join. Furthermore, corporate membership in the consortium provides three corporate SCDM memberships for representatives of the organization within the consortium. Benefits include the opportunity for networking and information sharing with professionals who are passionate about promoting eSource, learning about and contributing to industry eSource initiatives, and sharing the results of eSource projects in a forum that is protected by confidentiality and anti-trust policies administered by the SCDM.
Advarra-Forte is the first technology provider to join SCDM’s eSource Implementation Consortium, demonstrating its commitment to fostering collaboration between sites, sponsors and vendors to promote greater efficiencies and improved research outcomes. The SCDM eSource Implementation Consortium is now open to new members. If you are in the biopharmaceutical, technology or research site spaces, this is your opportunity to have a seat at the table in these important discussions and to help drive the transformation of clinical data management through developing eSource implementation best practices and standards. You can learn more about joining the consortium on the SCDM website.
Advarra-Forte’s commitment to eSource initiatives extends beyond its membership in the consortium. Forte EDC’S lab results interface allows organizations to pull lab data from a source system into eCRFs using SMART on FHIR. The lab results integration between EHR systems and Forte EDC allows research institutions to gain efficiency in their investigator-initiated trials (IITs) today, paving the way for further efficiency across the industry by providing the foundation for site and sponsor integration. Additionally, research institutions looking to interface their instance of Forte EDC with their Epic EHR System are able to take advantage of Epic’s new USCDI on FHIR program, allowing sites to use FHIR-based interfaces to connect directly with Epic.