This two-day conference for Clinical Research Professionals will study, explain, and discuss how ICH GCP and the Code of Federal regulations guide and direct investigator and sponsor responsibilities related to post approval monitoring, modernizing consent, adherence to clinicaltrials.gov and the NIH Data Management and Sharing policy. The attendee will understand and be able to convey the responsibilities of these very important functions, the complementary role of the clinical researcher as a fundamental contributor to successful clinical research and the protection of research subjects.
The program will focus on the relationships among clinical trial staff, investigators, IRBs the FDA, CROs and sponsors. The conference will highlight areas that present challenges to sponsors and investigational sites: navigating single IRB, writing effective informed consent documents, improving the informed consent process, use of genomic data, future use of stored bio-specimens, and risk-based monitoring communication. Discussion surrounding research in the virtual world since the recent pandemic and pain points that continue after the implementation of the Common Rule revisions will be explored. Insights about establishing a robust educational program and accessing effectiveness of the program on an ongoing basis will also be examined.
The program will identify best practices and strategies to provide potential solutions for these challenges. Insights about establishing a robust educational program and accessing effectiveness of the program on an ongoing basis will also be examined.
Learning Objectives: Upon completion of the program, the attendee should be able to: