7/14/2020
Topic: Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA Guidance
When: July 30, 2020
Time: 1:00 p.m. – 2:00 p.m. EDT
Register: Here
Description: 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 need 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.
Join Sandra “SAM” Sather as she presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. It 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.
Key take away benefits:
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.
Recognize best practices for oversight of the use of electronic records.
- The Clinical Pathways Team
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