Selecting the Right Electronic Data Capture (EDC)

Clinical Trials

What is EDC?

EDC stands for electronic data capture. This usually refers to the processes of an electronic system to manage clinical data. EDC systems may include electronic case report forms (eCRFs), electronic clinical outcomes assessments (eCOAs), electronic informed consent (eConsent), and randomization and trial supply management (RTSM).

What are the differences between EDC and CTMS?

A Clinical Trial Management System (CTMS) focuses on operation management whereas an EDC is primarily for data management. CTMS can include patient tracking, invoicing, monitoring, and document management. Depending on the scale and complexity of the study, you may want your EDC to include CTMS features or be integrated with CTMS programs.

What are the regulatory provisions for EDC?

In the US, requirements for electronic records can be found in 21 CFR Part 11. If clinical data are initially collected in an eCRF, the eCRF may be considered as a “source document”. FDA guidance “Electronic Source Data in Clinical Investigations recommends best practices and clarifies aspects of electronic source data. The eCRF may include a mix of source data and non-source data depending on the data originator. Electronic medical/health records are the most common type of source documents. For example, if pre-procedure exam data (e.g., weight, blood pressure, blood oxygen saturation levels) are entered directly or automatically transmitted into the eCRF, the eCRF would be considered as source data. If operation notes were recorded on paper that were later added to the comments section of an eCRF, the paper notes would be considered as the source. Because eCRFs may include source data and non-source data, data elements should include identifiers of data originators in the audit trail. Like paper CRFs, eCRFs should follow the same monitoring and review, retention policies, data access, and record keeping. The investigational plan or data management plan should include the purpose, security, and process of using computerized systems.

What are the advantages of using EDC?

In the age of technology, a growing amount of clinical data is collected, processed, or stored electronically. The COVID-19 pandemic demonstrated the value of telehealth and electronic records. As of 2019, almost 90% of office-based US physicians use electronic medical/health records. Careful selection and use of an EDC can improve data management while saving time and money. Some advantages of EDC systems include the following:

• Direct integration of medical record source data in the system can reduce the possibility of transcription errors
• Computer-generated queries reduce data validation time
• Viewing data in real-time can aid in patient safety and remote monitoring
• Organization options, filtering, and search functions can be tailored to management needs

What are the challenges of using EDC?

Like many electronic systems, there remain risks of user difficulties, system crashes, data loss, and security breaches. However, these risks can be mitigated through selection and proper use of the right EDC system. Learning a new system can be cumbersome for site personnel. To overcome this, many EDC system vendors offer demos and training so site personnel can experience the system before the study. User acceptance testing under normal, expected conditions and stress scenarios can be used to pre-emptively identify issues that may arise. Vendor audits can verify data security policies and review reports of system outages.

What is the right EDC for my study?

When evaluating different EDC systems, there’s more than just cost to consider. The first step in determining what EDC system to use is to understand the needs of the study. For example, if you have a global study, you will probably need the user interface in a variety of languages and would like to have customer support available beyond US business hours. The next step is to match your needs with the EDC capabilities. If your CRFs have many branched questions of different variable types, you may need more of a code-based system with branched logic rather than a drag-and-drop brick builder to be able to create complex CRFs.

You may decide to design, build, and validate your own EDC. Read our blog about designing and building an EDC with users in mind.

Below are examples of possible features of EDC systems to consider when selecting or designing an EDC.

Security and Compliance

• Audit trails
• User access controls
• Certified digital signature
• Version control
• Safety alerts

Data entry and processing

• Variety of Field Types
• Data Validation
• Automatic and manual query generation
• Automatic variable coding (e.g., binary, CDISC)
• Branched logic for contingent questions
• Export format compatible with Excel and/or statistical programs
• Integration with electronic medical/health records
• Medical imaging upload

User Interface

• Multi-site view
• Subject status summary
• Study calendar with reminders to site coordinators
• Query manager
• User-controlled CRF builder
• Language variety

System

• Notification of planned and unplanned system outages
• Frequent back-up
• Customer service
• Web browser, tablet, and mobile capabilities

MED offers a variety of clinical trial services and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us today to start your project discussion.
855.463.1633 | askmed@medinstitute.com | medinstitute.com.