As clinical researchers, we are challenged to fully integrate the management systems needed across functional areas within our electronic systems. Most frequently, the IT group and vendor manage the technology, but software AND process needs to be managed and understood by other cross functional areas when conducting day to day trial activities to support human subject protection and data integrity. This includes pre-study protocol development, vendor and site selection activities, subject safety surveillance, data management, site monitoring, protocol management, project management, and more.
This webinar presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. The session includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.
By attending this interactive session, you will be able to…
- Identify specific quality systems elements to support the use of electronic systems regarding sponsor, site, and IRB/EC regulatory responsibilities
- Avoid the most common misconceptions related to use of electronic records
- Recognize the process of ensuring the use of electronic records supports the predicate rules for sponsors, investigators, and IRBs/ECs