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Good Clinical Practice in Research at an Academic Research Institution
December 5, 2019 @ 2:00 pm - 5:15 pm EST
November 14 | November 21 | December 5 | December 12
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: November 14, 2019, 2:30-4:15 pm
• Introduction to Good Clinical Practice
• Privacy and Security in Clinical Research
Session 2: November 21, 2019, 2:00-5:00 pm
• Regulatory Requirements and Human Subjects Research
• Research Protocol
• Process of Informed Consent
• Essential Documents
Session 3: December 5, 2019, 2:00-5:15 pm
• Unanticipated Problems
• FDA Regulations: IND/IDE
• Study Monitoring
• Drug Accountability: Clinical Trials Pharmacy
• Drug/Device Accountability: Site Perspective
Session 4: December 12, 2019, 2:15-5:00 pm
• Standard Operating Procedures
• Study Audits
• Potpourri of IRB Issues
Note: To receive a certificate of completion a participant must attend all 4 sessions and successfully pass a post-course assessment through RedCap. RCR Eligibility: Completion of all 4 sessions of this course will fulfill two lecture/discussion requirements.