North Texas Chapter: Safety Reporting Requirements for Clinical Investigators, Sponsors & IRBs
Speaker:
- Michelle J Hines, Supervisory Investigator/Regulatory Officer, FDA/Office of Regulatory Affairs/Office of Tobacco and Medical Products/Division of Bioresearch Monitoring II
Program Description:
This Adverse Event Reporting presentation is designed to provide insight into what an adverse event is and why it is important to properly document during a clinical study. This presentation will also discuss the similarities and differences of reporting adverse event(s) as a Clinical Investigator, IRB and/or sponsor. It will also give details as to the appropriate procedures to follow when reporting an adverse event and demonstrate what a safety summary may entail.
Upon completion of this Seminar, attendees should be able to:
- Define terms related to clinical research safety reporting
- Outline Clinical Investigator, Sponsor and IRB reporting obligations
- Identify related procedures and safety summaries
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Program Agenda:
- 8:30 – 9:00 am CDT Log on and ensure connectivity
- 9 - 11:00 am CDT Presentation, Questions & Answers
Registration Cost (please click here to register) Registration restricted to the first 100 registrants:
- Chapter Members: $0
- ACRP Members: $0
- Non-Members: $0
Contact Hour Cost:
- Chapter Members: $0.00
- ACRP Members: $25.00
- Non-Members: $40.00
Refund Policy: Not applicable