Building an electronic data capture (EDC) system for a clinical study involves several steps that must be carefully planned and executed to ensure data accuracy, completeness, and security. Here is a step-by-step checklist to guide you through the EDC clinical study build process:
- Determine study requirements: Review the study protocol and identify the data elements that need to be collected, how often they need to be collected, and any specific data validation rules that should be applied.
- Choose an EDC system: Select an EDC system that meets the requirements of the study and that is compliant with regulatory standards.
- Define study database: Set up the study database, including creating tables to store data, setting up user accounts and security permissions, and configuring the system to allow for data import and export.
- Build study forms: Build electronic forms in the EDC system to collect the data needed for the study. Use a consistent layout and formatting to make it easy for users to navigate the system.
- Configure edit checks: Set up edit checks in the EDC system to ensure data quality and reduce errors. Edit checks should be based on the requirements of the study and may include range and consistency checks, data type checks, and logical checks.
- Test system: Test the EDC system to ensure that the forms and edit checks are working correctly. Run test cases to simulate data entry and ensure that the system is functioning as expected.
- Train users: Train users on how to use the EDC system, including data entry, data management, and data validation. Provide user manuals and online resources for reference.
- Conduct user acceptance testing (UAT): Invite users to participate in UAT to ensure that the system meets their needs and is easy to use. Gather feedback and make any necessary adjustments.
- Obtain regulatory approval: Obtain regulatory approval for the EDC system before the study begins. This may include submitting the EDC system to regulatory authorities for review.
- Launch system: Launch the EDC system for data collection at the start of the study. Ensure that users have the necessary access to enter and manage data, and monitor the system to ensure that it is functioning properly.
- Monitor system: Monitor the EDC system throughout the study to ensure that data is being entered correctly and that the system is functioning as expected. Monitor user activity and data quality, and address any issues that arise.
- Close out study: Close out the study by archiving the data in the EDC system and ensuring that all regulatory requirements are met. Ensure that the data is secure and accessible for analysis.
By following this step-by-step checklist, you can build an effective EDC system for your clinical study that meets the requirements of the study protocol and regulatory standards.
Cloudbyz EDC is a user-friendly, cloud-based solution that is designed to store and manage clinical data effectively throughout a clinical trial’s life cycle. Our innovative solution enables clinical research teams to efficiently collect, analyze, and manage clinical data of different complexity and size. Cloudbyz EDC is a scalable solution and meets all the essential regulatory compliance requirements such as FDA- 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU- GDPR.