Implementing eSource: A Guide for Operations and Technology Roles
There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data collection. Eliminating the requirement for manual data transcription leads to significant savings in terms of the costs and time spent on a study.
However, adopting eSource is challenging for many research facilities. Successfully implementing eSource requires sites to shift from paper-based data to electronic data records in a way to preserve data integrity and patient safety.
Best Practices for Implementing eSource
eSource must be implemented in a way to ensure data reliability and trustworthiness. To achieve this, sites should adhere to the eSource principles of use.
Use “Fit for Purpose” Solutions
The chosen method of eSource documentation should align with a trial’s specific needs. Factors to consider include:
- Study type and location
- A site’s technological capability
- Patient population
- Cultural considerations
- Protocol adherence
The eSource system must export data in a format most easily integrating with the site’s electronic data capture (EDC) system. This is to ensure all electronic data (from digital medical devices or electronic health records [EHRs]) is successfully captured.
Research sites may elect to collect data using eSource, paper source, or a combination of the two. Whichever they decide, they must specify their chosen method of source documentation in the protocol and keep it consistent for all participants. The investigator must maintain a source data location list to ensure data integrity and patient safety.
Capture Data When First Generated
The main advantage of eSource over other data collection methods is its potential to improve data quality, accuracy, and availability. To realize these advantages, clinical data should be captured electronically at the point of care. This is essential to avoid transcription errors and to allow timely data review by the principal investigator (PI) and sponsor safety reviewers.
Immediately capturing data enables real-time quality checks, further ensuring an accurate and complete audit trail. This enables research sites to closely adhere to data quality standards and regulatory guidelines. Replacing other methods of data collection with eSource also reduces review of the quantity of records.
Data capture at the point of generation may require a site to change its workflow; in these cases, the new workflow should be designed in such a way most efficient for the site.
Control Electronic Data
Appropriately controlling electronic data helps protect data integrity and participant safety and confidentiality. This is typically achieved through a combination of procedural, physical, and electronic methods.
Procedural methods include parsing out staff duties and adhering to standard operating procedures (SOPs). Physical measures involve establishing different server locations to ensure server redundancy. Electronic measures include computer security rights and roles to protect data integrity and participant privacy.
If any data modifications are made, a clinical investigator or other designated site staff must be the ones to make the changes, and they must be traceable.
Leverage Automated Quality Checks
Quality checks are key for ensuring data integrity and reliability. Data verification checks should be programmed into the data capture system to verify accuracy and consistency in real-time.
If electronic data is uploaded via device or machine (e.g., using a digital thermometer or blood pressure cuff), both the device and transfer system must be verified.
Control for Quality
All data must meet the ALCOA+CCEA standards for data integrity. This means all data must be attributable, legible, contemporaneous, original, and accurate. Additionally, data should be complete, consistent, enduring, and available.
- When capturing eSource data, researchers must detail who made the entry, when the entry was made, and the electronic source from which it was derived. Staff should also implement user accounts and security controls for each individual granted access to the system.
- All eSource data must be recorded legibly and in the appropriate language.
- Date clinical measurements, observations, and data entry into the eSource system to ensure electronic data is contemporaneous.
- Quality controls must be put in place to ensure data is accurate. These controls should validate the data transfer system, ensure acceptable calibration on devices capturing data, and confirm proper usage of data capture devices.
- All eSource data must be complete. To achieve this, the transfer process should be validated, and the system should be programmed with automated edit checks to ensure all data was collected from an electronic source.
- Programmed edit checks can be used to ensure data consistency across all electronic sources.
- To ensure data is enduring, technical controls should be put in place to maintain eSource records for as long as specified.
- All electronic records must be available for review and stored in a format suitable for assessment.
Conform to Regulations and Guidelines
All eSource systems should align with governmental regulations and guidelines for the use of electronic source data. Regulations emphasize the need for accurate and controlled record-keeping to ensure trustworthy data. To meet these requirements, sites must understand the data flow of eSource and how it meets regulations, and they must maintain case histories for each participant.