MGH Research Institute

QI Bootcamp for Clinical Researchers and Study Staff

Speaker: Pamela Richtmyer, Director, Partners Human Research Quality Improvement Program

The QI Program and the MGH Division of Clinical Research are excited to offer QI Bootcamp. QI Bootcamp is a “clinical research 101” for study staff and investigators. The goal of the course is to review GCP guidelines and institutional policies, and instruct study staff and investigators on how to implement those guidelines and policies into the day to day conduct of clinical research. Topics include:

• Informed Consent documentation
• Study Documentation (source documents and data collection forms)
• Unanticipated Problems, Deviations and Violations
• Investigational Product Accountability
• Regulatory binder
• CT.gov, inspections and common rule revisions