Source data is all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. The electronic data source or eSource is the data that is initially recorded in electronic format in this process.
Biopharma and MedTech companies are gradually introducing eSource using electronic tools to improve standards of clinical trial execution and simplify the process for patients and sites. Read on as we discuss why eSource is advised, how it can be implemented, process barriers sponsors must prepare for and benefits it can offer.
Why sponsors should implement eSource
Adoption of eSource is advised by regulators to optimize the use of electronic data sources and thus efficiently gather data to benefit patients and sites and in turn sponsors. Electronic data sources that are used as primary data sources eliminate/reduce the need to transcribe them manually. This speeds up the data capture and ensures data integrity throughout the trial.
Data source identification for eSource
Sponsors would have to consider all data sources and install data capture systems in their place to integrate completely enabled eSource. The clinical data sources/ devices/ tools required for enabling such a system can be categorized into four types.
- Non-CRF: Data from sponsors and vendors to data repositories and warehouses without going through Case Report Forms.
- Lab reports (verbal)
- Medical images requiring professional interpretation
- Devices & Apps: Clinical data gathered from wearable devices and sensors.
- Electronic Clinical Outcome Assessment (eCOA)
- Mobile device data
- Sensors & wearable device data
- Data from vendor device cloud
- eConsent application data
- Direct Data Capture: Primary clinical data directly entered into an EDC or a mobile application during the subject’s visit.
- DDC devices
- Site data sources
- Electronic Health Record: Patient/subject’s electronic health records shall be collected and reused for clinical research.
- Site-based EHR
- Study data packages
- Patients’ health records
- Public data sources
- Health Information Exchanges (HIE)
Process barriers for eSource implementation
As the scope for eSource grows, some challenges are pertinent. From technological limitations to guiding principles, we present some barriers that sponsors might face during the implementation of eSource and also provide insights on how they can prepare to mitigate them.
- Lack of comprehensive regulatory guidelines continues to influence sponsors’ decisions to implement eSource in trials. FDA has started working in this direction however more guidance in terms of devices, apps, and other channels for eSource is yet to be published. Companies can collaborate with regulatory agencies to this expedited process.
- Data acquisition from different sites needs to be normalized for metrics. Site-specific requirements could lead investigators to choose different metric systems. Sponsors can implement measures using SOPs to check for metric normalization before the data is used in clinical research.
- All data source systems/devices must be validated for compliance with 21 CFR Part 11 and Annex 11 to ensure audit readiness
- Patients must be briefed about devices used for automated data collection in advance to address data privacy concerns before recruiting them for the trial to retain
- System interoperability is pivotal for eSource and all systems used for data collection must be capable of readily connecting and exchanging information from different sites with appropriate measures for data access.
Benefits of eSource in clinical studies
Implementing eSource in clinical trials offers benefits that improve data quality and compliance of the study by
- Eliminating data duplication
- Minimizing transcription errors
- Promoting real-time entry for eSource
- Optimizing data accuracy and completeness
Sponsors should not view eSource as just as electronic enablement for gathering data but as a dynamic system that can be customized to adapt to the needs of individual study. They must work with sites and patients to understand the limitations and scope for designing a suitable system. Finally, quality and compliance requirements must be defined as per local regulations.
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- Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective, March 2020, https://pubmed.ncbi.nlm.nih.gov/32865798/
- Optimizing Use of Electronic Data Sources in Clinical Trials, 2016, https://pubmed.ncbi.nlm.nih.gov/30231687/
- Wikipedia De-identification, https://en.wikipedia.org/wiki/De-identification
- Enable eSource Clinical Research Data in Drug Development, 2018, https://www.devdays.com/wp-content/uploads/2019/03/DD18-EU-Michele-Cherry-Enable-eSource-Clinical-Research-Data-in-Drug-Development-2018-11-15.pdf
- Guidance for Industry – Electronic Source Data in Clinical Investigations, FDA, September 2013, https://www.fda.gov/media/85183/download