Step-by-step guidance for successful and accurate digitization of COAs
Developed in collaboration with COA developers and eCOA technical experts, eBooklets provide detailed requirements and recommendations specific to each COA and to each digitization step.
The eBooklets are key resources for individuals responsible for the electronic implementation of COAs (eCOA designers and architects, clinical trial managers, project managers), ensuring optimized and accurate development of eCOAs while protecting COA integrity.
Why use the eBooklets developed by Mapi Research Trust?
- Access simple, screen-by-screen guidance on how to develop a validated version of the COA
- Ensure the integrity of the original COA through application of developer/copyright holder COA-specific requirements and eCOA best practices
- Optimize your timelines and budget by reducing the number of screenshot review rounds
- Help ensure standardized digitization of COAs across various vendor platforms
What guidance is provided in eBooklets?
- Instrument properties (original COA version, language, type of instrument)
- Acceptable modalities/devices
- Design requirements: Minimum eCOA control requirements and behavioral requirements
- Additional considerations and specific author/copyright holder’s requirements: Includes requirements and recommendations on skipping, best practices, workarounds, etc.
- For complex COAs, instrument workflows are included to demonstrate branching or other functions requiring a visual representation
- Screen examples with specific references and formatting rules
If an eBooklet does not exist for the COA intended for eCOA implementation, Mapi Research Trust will provide the User Guide for eCOA Implementation with recommendations based on the industry best practices.
eBooklets’ Updates: Ensuring up-to-date and flexible guidance
The eCOA industry is continually evolving, with new best practices, regulations and technologies. It is our goal to ensure that eBooklets are always aligned with current industry practice.
Regular eBooklet updates include:
- Inclusion of new or revised COA content
- Adherence to current eCOA best practices and regulatory requirements
- Clarity of information and instruction
- Inclusion of acceptable eCOA design alternatives, based on ongoing collaboration with author/copyright holder