Good Clinical Practice in Research at an Academic Research Institution
May 30 | June 6 | June 13 | June 20 | June 27
185 Cambridge Street | Simches 3rd Floor, Room 3.110
Sponsored by the MGH Division of Clinical Research, Partners Human Research Committee and Partners Human Subjects Quality Improvement Program
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 as well as describe the essential documents needed for the conduct of a study. Compliance with GCP assures that the rights, safety, and welfare of subjects are protected and that the data produced from the research are credible.

After completing this training the learner will have a comprehensive understanding of GCP and be able to apply those practices to the conduct of clinical research.

Session 1: May 30th 2:00-4:30pm
• Why is GCP important?
• Privacy and Security in Clinical Research
• Introduction to Good Clinical Practice

Session 2: June 6th 2:00-4:30pm
• Regulatory Requirements and Human Subjects Research
• Research Protocol
• Recruitment and Retention
• Process of Informed Consent

Session 3: June 13th 2:00-4:30pm
• Essential Documents
• Unanticipated Problems
• FDA Regulations: IND/IDE

Session 4: June 20th 2:00-4:30pm
• Pediatric Studies
• Drug Accountability: Clinical Trials Pharmacy
• Drug/Device Accountability: Site Perspective
• Standard Operating Procedures

Session 5: June 27th 2:00-4:30pm
• Study Monitoring
• Study Audits
• Potpourri of IRB Issues
• Research Misconduct
• Wrap Up

Note: To receive a certificate of completion a participant must attend all 5 sessions and successfully pass a post-course assessment through RedCap. RCR Eligibility: Completion of all five sessions of this course will fulfill two lecture/discussion requirements.