Since the inception and publication of the first randomized clinical trial in 1948, the scale, complexity, and cost of trials have all significantly increased. Changes in information technology have offered opportunities to increase efficiency and focus on the most relevant activities. When the original guidelines and ethical standards on conducting clinical trials entitled ‘International Conference on Harmonization – Good Clinical Practice’ (ICH-GCP) were released in 1996, clinical trials were performed in a process that was primarily paper-based.
Recent advances in electronic data recording and reporting tools have given rise to other more efficient and streamlined approaches. Most specifically, the clinical trial space’s case report form (CRF) is now almost predominantly electronic in design. It has been for approximately the last ten years preceding the writing of this report, at which time paper-based CRFs were gradually being phased out.
Electronic Data Capture (EDC) systems have revolutionized how researchers collect and manage data in clinical trials and research studies. The case report form (CRF) within the clinical trial space is now almost predominantly electronic in design, with very few that are still paper-based left.
Choosing the right EDC system requires careful consideration to ensure data integrity, compliance, and efficiency. Researchers should consider these top 10 factors before selecting and implementing an EDC system:
1. Study Design and Complexity:
Think about the complexity and specific requirements of your study design. Ensure that the EDC system can accommodate various study designs, such as randomized controlled trials, observational studies, or longitudinal research (including disease registries). Also, think about future work – while your current study may be one
type, over time, you may have more complicated studies, and moving to another system can be cumbersome and time-consuming, as well as increasing training times. Choosing a scaleable solution can mitigate these pitfalls.
2. Ease of Usability:
Evaluate the system’s user interface and ease of use. A user-friendly EDC system simplifies data entry, enhances the user experience, and reduces training time for research staff.
Evaluate it from the participant’s perspective if you intend to capture Patient Reported Outcomes (PROs). Can they quickly and easily provide information via a survey or other application integrated with the EDC system?
3. Data Security and Compliance:
Your EDC system must comply with data protection regulations such as HIPAA, GDPR, ISO27001, and 21 CFR Part 11 (if running a clinical trial). Verify that the system has appropriate security measures in place, including encryption, user authentication, audit trails, and backup procedures. You can also ask for the certificates related to these standards for your records.
4. Integration Capabilities:
Assess the ability of the EDC system to integrate with other systems essential to your research, such as laboratory information management systems (LIMS), electronic health records (EHR), or statistical analysis software. An EDC with built-in integrations streamlines data capture and reduces manual data entry errors while speeding up data collection.
5. Customization and Flexibility:
Make sure the EDC system allows customization to meet your specific study requirements. Look for features such as customizable forms, capturing Patient Reported Outcomes directly from participants, and adding new data elements or editing existing ones during the study.
6. Data Validation and Quality Control:
Confirm that the EDC system supports built-in data validation features, such as checks for range, consistency, and logic. Quality control measures, such as automated data checks, help ensure data accuracy and completeness.
7. Accessibility and Remote Data Entry:
Determine if the EDC system supports remote data entry, enabling researchers and participants to access and input data from multiple study sites and locations. Remote data entry facilitates real-time data capture and improves participant engagement. Furthermore, check that accessibility features are built-in to support participation by the most diverse population.
8. Reporting and Data Exporting:
Review the reporting functions of the EDC system and confirm that the included features allow for customizable reports and real-time data visualization and that standard export options in formats are available (e.g., Excel, PDF) to facilitate data analysis and regulatory submissions.
9. Training and Support:
Consider the availability of training resources and technical support provided by the EDC system supplier, such as comprehensive training sessions, user guides, and technical support to assist with any issues or questions that may arise during the study. Remember to check for any hidden support costs thoroughly before signing up.
10. Cost and Budget:
Evaluate the overall cost of implementing and maintaining the EDC system, including licensing fees, hosting costs, and any additional services or modules required. Can everything needed for the study be done with a single system, or will you need another vendor for trial Documentation (e.g., eTMF) that could take more out of your budget?
Choosing the right EDC system is a significant factor in the success of your clinical trial or research study. The 10 factors above are vital in helping researchers make an informed decision and choosing the right EDC system that meets their specific needs and budget before getting stuck with a solution that doesn’t.
Do you have questions about how to choose the best EDC for your clinical trial? We can help. Contact us at info@acquishealth.com or visit us at www.acquisbi.com/clinicaltrials