EMA Provides Direction on Computerized Systems, Electronic Data
The European Medicines Agency (EMA) has published a comprehensive final guidance that offers general principles for specific computerized systems, processes and data in the areas of validation, user management, security and electronic data as well as computerized systems implemented at the site level.
The 52-page guidance pertains to instruments, software and software as a service used to gather electronic clinical data and control processes that could potentially impact trial participant protections and data reliability, including:
- Electronic health records;
- Electronic clinical outcome assessments;
- Wearables and sensors;
- Electronic case report forms;
- Tools that automatically gather transit and storage temperatures of investigational medical products and clinical samples;
- Medical imaging, liquid chromatography-mass spectrometry systems and related software;
- Electronic trial master files;
- Electronic informed consent;
- Interactive response technologies for managing the randomization, receipt and supply of investigational medical products;
- Systems used to conduct remote monitoring/auditing; and
- AI solutions for recruitment, eligibility determination, coding of events and concomitant medication, data clarification, querying and event adjudication.
Read the guidance here: https://bit.ly/3FBatwH.