The eSource Initiative supports TransCelerate Member Companies in accelerating the uptake of eSource for clinical trials. Although regulators have urged increased use of eSource for several years, application of the use of electronic sources of data for clinical trials has been slow to be adopted across the industry, particularly for registration trials, due in part to difficulties in operationalization. Research indicates there are numerous obstacles and challenges behind this delay; some real and some perceived. The eSource initiative seeks to assist member companies, and ultimately other trial sponsors in overcoming these real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.
As the data for clinical trials becomes less about collecting protocol-defined data points, and more about using data from patient records and other electronic sources such as devices and apps, electronic interoperability and consistent use of data standards become paramount. The 4 eSource categories defined by the TransCelerate eSource initiative are:
- EHR/EMR (Electronic Medical Records/Electronic Health Records): Covers collection of clinical data for use in clinical research from site/patient electronic health record systems.
- Devices & Apps: Covers collection and management of clinical data from non-site personnel (e.g., subjects, participants, and caregivers) using mobile devices including smartphone or tablet applications (e.g., electronic clinical outcome assessment), wearables, and sensors (e.g., glucose monitor, smart pill, remote chemistry, ambient sensors).
- Non-CRFs: Includes collection and transfer of data in electronic format from internal sponsor sources (e.g., specialty laboratories) or external vendors (e.g., laboratory results, imaging, ECG, randomization, drug accountability) into clinical research data repositories/warehouses without entering the data onto a Case Report Form (CRF).
- Direct Data Capture: Includes direct entry of clinical data by site staff into a mobile application or EDC system.
- Potential to eliminate duplicate data entry, reduce transcription errors
- More informed vendors
- More engaged patients
- Greater efficiency for sites and monitors (potential for full RBM)
- Potential for improved Health Authority review/approval process
- Greater traceability for end to end data flow
The following assets are in development:
- Points of view defining a framework to enable adoption of eSource
- Playbook for sponsors to facilitate implementation of e-Source
- Collaborative Health Authority engagement plan and materials
- Validation projects to demonstrate success with eSource for clinical trials for registration
The eSource Initiative is also holding a series of eSource Advancement Roundtables, intended to assemble industry leaders in a collaborative effort to move the needle on the use of eSource data and interoperability in clinical research. Materials from these roundtables, as well as the Initiative’s other publications can be read by clicking to our Initiative Assets page below.
Quality Management System
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring initiative seeks to develop an model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.