Ended: March 1, 2021
Speaker: Pamela Richtmyer, Director, Mass General Brigham Human Research Quality Improvement Program
The QI Program Clinical Research Bootcamp is a “clinical research 101” for study staff and investigators. The course is not only an introduction to clinical research for new investigators and study staff but also good review for experienced study teams. Many teams include this course as part of the onboarding process for new study staff. The course covers research regulations, GCP guidelines, and institutional policies relevant to the day to day conduct of clinical research. Topics include:
• Informed Consent documentation
• Study Documentation (subject files, source documents, and data collection forms)
• Unanticipated Problems, Deviations and Violations
• Investigational Product Management and Accountability
• Regulatory Binder and Essential Documents
• ClinicalTrials.Gov
• Inspections and audits
• Other relevant topics
RCR Eligibility: Completion of this course will fulfill two lecture/discussion requirements.
Program: Responsible Conduct of Research Program at MGH
Sponsor: MGH Division of Clinical Research
Sessions
March 1, 2021
03/1/21 10AM-12:30PM |
10 AM – 12:30 PM |
STRATUS Online Moodle, None
|