DCR- RCR Program: QI Bootcamp for Clinical Researchers

Sponsored by the MGH Division of Clinical Research

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

*This course is worth 2 RCR credits.