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M410- Clinical Research Study Management and Compliance (CRSMC)- Fall 2025
Week 4: Thursday, September 25, 2025- Investigational New Drug and Data & Safety Monitoring Committees
Recording for Week 4: Investigational New Drug and Data & Safety Monitoring Committees
Recording for Week 4: Investigational New Drug and Data & Safety Monitoring Committees
Completion requirements
Recording for Week 4: Investigational New Drug and Data & Safety Monitoring Committees
◄ Slides for Week 4: Investigational New Drug and Data & Safety Monitoring Committees
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Syllabus for M410- Clinical Research Study Management and Compliance (CRSMC)- Fall 2025
Course Survey for M410- Clinical Research Study Management and Compliance (CRSMC)
Questions for Session 1
Recording for Session 1: Introduction to Clinical Research Implementation and Management
Slides for Session 1: Introduction to Clinical Research Implementation and Management
Questions for Session 2
Recording for Session 2: Human Subjects Protection
Slides for Week 2: Human Subjects Protection
Questions for Session 3
Slides for Session 3: The Scientific Protocol Review Process at MSK and other NCI Designated Cancer Centers
Recording for Session 3: The Scientific Protocol Review Process at MSK and other NCI Designated Cancer Centers
Questions for Session 4
Slides for Week 4: Investigational New Drug and Data & Safety Monitoring Committees
Slides for Week 4: Investigational New Drug and Data & Safety Monitoring Committees
Questions for Session 5
Recording for Session 5: Logistics of Enrolling Patients – Reducing Barriers to Clinical Trials
Slides for Session 5- Logistics of Enrolling Patients – Reducing Barriers to Clinical Trials
Article #1- How do doctors explain randomised clinical trials to their patients?
Article #2- Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials
Questions for Session 6
Recording for Session 6: Subject Safety (2021 Lecture)
Slides for Week 6: Subject Safety (2021 Lecture)
Questions for Session 7
Slides for Session 7: Sponsor – Investigator Relationships and Responsibilities (Riely)
Slides for Session 7: Sponsor – Investigator Relationships and Responsibilities (McCarthy)
Recording for Session 7: Sponsor – Investigator Relationships and Responsibilities
Questions for Session 8
Slides for Session 8- The Patient’s Perspective
Recording for Session 8- The Patient’s Perspective
Questions for Session 9
Slides for Session 9: Securing Multidisciplinary Support and Multimodality Studies
Recording for Session 9: Securing Multidisciplinary Support and Multimodality Studies
Questions for Session 10
Recording for Session 10- Conduct of the Trial Part I
Slides for Session 10- Conduct of the Trial Part I
Questions for Session 11
Recording for Session 11- Conduct of the Trial Part II
Slides for Session 11- Conduct of the Trial Part II
Questions for Session 12
Slides for Week 12- Multicenter Trials (Morris)
Slides for Week 12- Multicenter Trials (Warren)
Recording for Week 12- Multicenter Trials
Questions for Session 13
Slides for Session 13- Effective Documentation and Corrective and Preventive Action Plan Reviews
Recording for Session 13- Effective Documentation and Corrective and Preventive Action Plan Reviews
Questions for Session 14
Slides for Session 14: Financial Accountability
Recording for Session 14: Financial Accountability
Questions for Session 15
Recording for Session 15: FDA Regulations
Questions for Session 5 ►
