Overview:
This presentation will provide an overview of the sponsor responsibilities for conducting clinical research. The presentation will address sponsor responsibilities for regulatory submissions, site selection, documentation, and monitoring. Safety and regulatory reporting will also be discussed. As clinical trials expand throughout the globe, it is important to understand the regulatory and ethical responsibilities of the Sponsor.
This is a 20 minute internet media player video of a voice over slide show.
A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.
Learning Objectives:
At the completion of the webinar, participants should be able to:
- Describe sponsor responsibilities for conducting clinical research
- Discuss responsibilities for regulatory submissions, site selection, documentation and monitoring
- Discuss safety and regulatory reporting
Speaker:
Ms. Amy Jo Jenkins, MS, CCRP
Amy Jo Jenkins has 20+ years of experience working in clinical research and currently serves as the Executive Director of the Translational Research Institute at the University of Arkansas for Medical Sciences, where she also teaches courses in the Regulatory Science Program. She earned her Masters of Science degree in Clinical Research Organization and Management from Drexel University and Bachelors of Science degree in Molecular Biology from Grove City College. She has been a Certified Clinical Research Professional since 2010 and has served on the SOCRA Board of Directors since 2016.
Cost:
Members – Free
Non-Members – $75.00(includes 1 year membership)
Register:
If you are not a current member, you will be asked to create an account to view the online training.
Continuing Education Credit Hours:
SOCRA designates this educational activity for a maximum of 0.5 Continuing Education Credits for SOCRA CE and Nurse CNE.
SOCRA designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.
Accreditation Statements:
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Start Date: 4/1/2023
Termination Date: 4/1/2026