Good Clinical Practice (GCP) in Research at an Academic Research Institution

Good Clinical Practice (GCP) in Research at an Academic Research Institution

October 19, 2015 3:00 pm to 4:30 pm
BWH, Ramzi Cotran Conference Center, 75 Francis Street

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.


Schedule: Mondays (3:00 - 5:30pm)
October 19th
October 26th
November 2nd
November 9th


Lectures Include:
   Introduction to Good Clinical Practice
   Regulatory Requirements and Human Subject Protection
   Informed Consent Process
   Essential Documents
   Adverse Events
   Study Monitoring
   Impact of HIPAAA on Clinical Research
   Conflict of Interest
   FDA Regulations
   Research Compliance and Research Misconduct

CME credit is available:
Partners HealthCare System is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Partners Healthcare System designates this live activity for a maximum of 10.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Upon completion of this activity, participants will be able to:
1) Comprehend the principles of Good Clinical Practice.
2) Integrate the principles of Good Clinical Practice into the daily activities of research conduct. 
3) Make decisions about the research conduct relating to study management, protocol adherence, data collection, and reporting study results and subject safety.


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