Good Clinical Practice (GCP) is an international, ethical, and scientific quality standard for designing, conducting, recording and reporting human subjects research. GCP guidelines define the roles and responsibilities of the IRB, investigator and sponsor throughout the clinical trial and also describe the essential documents needed for the conduct of a clinical trial. Compliance with GCP ensures that the rights, safety and welfare of subjects is protected and that the data produced by the research is credible. After completing this training, participants will have a comprehensive understanding of FDA Good Clinical Practices and will be able to apply those practices to the conduct of clinical research.
Session I: June 13: 1:00pm - 4:15pm
- Keynote Address
- Introduction to Good Clinical Practice & Case Study
- Regulatory Requirements & Human Subjects Research & Genetic Research
- HIPAA, Privacy and Security
Session II: June 20: 1:00pm - 4:15pm
- FDA Regulations: IND/IDE
- Process of Informed Consent
- Drug and Device Accountability
- Essential Documents, REDCap Regulatory Binder, Demo
Session III: June 27: 1:00pm - 4:15pm
- Unanticipated Problems including Adverse Events
- Study Monitoring
- GCP for Coordinating Centers
- Study Audits and Case Study
Session IV: July 11: 1:00pm - 4:15pm
- Research Compliance and Examples of Noncompliance
- Research Misconduct
- Conflict of Interest
- Potpourri of IRB Issues
This is a highly interactive, four session course on the principles of GCP. In order to receive a certificate of completion a participant must attend all 4 sessions and successfully pass a post-course exam online.
Upon completion of this activity, participants will be able to: comprehend the principles of GCP; integrate the principles of GCP into the daily activities of research conduct; utilize the information provided during the course to make decisions about research conduct relating to study management, protocol adherence, collection of data, reporting study results and subject safety.
Registration is required. Please contact Jillian Tonelli with any questions.
This program meets the requirements of the Board of Registration in Nursing, at 244 CMR 5.00, for 16.0 contact hours of nursing continuing education.
RCR Eligibility: Completion of all four sessions of this course will fulfill two lecture/discussion requirements