A Brief Look at Electronic Data Capture (EDC) in Clinical Trials: Past, Present, and Future
What is EDC?
Electronic data capture (EDC) is a way to record medical data digitally instead of in the more traditional paper format. EDC can be used to record many different types of clinical trial data, such as:
- Medical data captured during clinical trials about patient status, conditions.
- Safety data related to clinical trials.
- Test results from labs or other suppliers
- Information from patients like Quality of Life (QOL)
- Patient information recorded by apps/devices (e.g. blood glucose monitors)
Some of the ways EDC out-performs paper-based clinical systems include:
- Efficient data capture: reduces delays due the need for forms to be properly translated and versioned, delivery time of completed forms to data entry staff, as well as the elimination of costs associated with the movement and management of paper files
- Data quality: minimizes the introduction of errors when data is transferred from paper records to an electronic database, built in edit checks catch data entry mistakes
- Data security and robustness tracks all changes made to patient records (i.e., date and time stamp, person making change to record, etc. )
- Adaptive data capture: allows real-time monitoring of the study and the ability to run up-to-the-minute data analysis
History of EDC and EDC Systems Today
EDC started out in the 1990s as ‘remote data capture’ (RDC), which was a way for patient data to be recorded electronically at clinical study sites. However, these RDC systems were often offline, isolated systems that did not send feedback directly to the study coordinators, and as such had limited utility.
Since then, these clinical systems have become more sophisticated, and other computer- and web-based systems such as electronic case report forms (eCRFs) and patient-reported outcome (PRO) systems have come into play. While all of these tools make it easier and quicker to conduct clinical trials, having so many different electronic systems creates its own set of problems. This is where EDC software come in, by pulling together all of the different pieces of the puzzle into a unified clinical system that effortlessly manages all aspects of a clinical trial.
EDCs today provide a single, user-friendly platform for accessing information entered into eCRFs, PROs, and more! A key feature of EDC software today is “electronic interoperability”, meaning that clinical systems used to record patient data should integrate easily with EDC systems used in clinical investigations. Using the standards defined by the Clinical Data Interchange Standards Consortium (CDISC) across all of the components of your EDC clinical system is one of the best ways of achieving this.
EDC Systems Future Trends
As EDC systems continue to evolve, users can expect to see:
- Uniformity of data capture which improves data quality
- A greater focus on patient safety
- Enhanced patient centricity and focus
- Improved speed of clinical trials (faster, shorter, better).
- Multiple sources of information = better analysis, more comprehensive, more robust.
- Wide use of artificial intelligence for clinical trials management (i.e., Risk Based Monitoring, patient recruitment, etc.) as well as for data analysis
- Improved system integration (i.e., safety, CTMS, eTMF, etc.)
Clinical trial data collected digitally (e.g., wearables, ePRO, etc.) into an eSource enabled EDC system, without having to record the data on a piece of paper first, has become increasingly common and allows for more timely and accurate capture of data. For example, eSource can be used to guide a clinical study coordinator through the questionnaire with a patient, and the patient’s answers are then recorded directly into their clinical study record. Data from wearable medical devices and sensors can also be deposited directly into EDC systems. This direct data capture method means an even shorter time from data collection to analysis.
EDC Regulatory Considerations
As EDC use has become more widespread, many countries have introduced regulations to help ensure that “electronic source data and source documentation…meet the same fundamental elements of data quality that are expected of paper records” (2007 FDA Guidelines for Computerized Systems Used in Clinical Investigations). When selecting and designing an EDC for use in your clinical study, it is crucial to follow the appropriate regulatory guidelines for your country:
- For the United States, relevant regulations include 21 CFR Part 11
- In Europe, the EU GMP Annex 11: Computerised Systems applies
- Japan has published ERES guidelines
- For Canada, the relevant regulations are contained in the Canadian Food & Drugs Act, Division C.02
- In addition, the ICH E6 (R2) Good Clinical Practice Guideline applies worldwide
What Features to Look for in an EDC Product
What should you look for when you’re deciding on which EDC system to use for your clinical trial? It’s important to take a close look at everything a potential EDC offers and make sure that it has all of the features you’ll need. Some of the most useful components to look for in a unified EDC system are:
- Patient-reported outcome (PRO) software
- A subject randomization and drug management system (Interactive Web Response System, IWRS)
- End-to-end use of CDISC standards to ensure interoperability throughout the lifecycle of the study
- Risk-based monitoring to protect participants in real-time
- Standardized coding (such as WHODrug and MedDRA)
- Clinical trial management system (CTMS) software, to manage data such as study site information and IRB approvals
- Double data entry (DDE) capability for paper and hybrid studies
- Reporting options, to generate standard and custom reports throughout the clinical trial
- Compatibility with all web browsers and all user languages, so that all of your clinical trial staff across all of your study sites can use the EDC easily
Interested in learning more? Visit our website to meet Marvin, our favorite EDC software, and find out what we can do for you!