M410- Clinical Research Study Management and Compliance (CRSMC)- Fall 2025

Topic outline

• Collapse all Expand all
  • Course Information

    Course Title: Clinical Research Study Management and Compliance  

    Course Number: M410

    Credits: 1

    Course Directors: Gregory J. Riely, MD, PhD, Christopher A. Barker, MD, Michael J. Morris, MD

    Grading Policy: Pass/Fail

  • 

    Syllabus for M410- Clinical Research Study Management and Compliance (CRSMC)- Fall 2025 File

• Week 1: Thursday, September 4, 2025- Introduction to Clinical Research Implementation and Management
  • Instructor(s): Paul J. Sabbatini, MD

    • Standard of Care vs Clinical Research                                                           
    • Administrative Oversight at MSK and beyond
    • The Responsibilities of the Principal Investigator in Clinical Research    
  • 

    Questions for Session 1 Assignment

    Due: Wednesday, September 3, 2025, 10:00 AM
  • 

    Recording for Session 1: Introduction to Clinical Research Implementation and Management File
  • 

    Slides for Session 1: Introduction to Clinical Research Implementation and Management File

• Week 2: Thursday, September 11, 2025- Human Subjects Protection
  • Instructor(s): Eileen M. O’Reilly, MD and R. Michael Tuttle, MD                   

    • The roles and responsibilities of the IRB
    • Vulnerable populations
    • Research Regulatory Bodies in the US that govern human protection       
      • FDA, OHRP 
  • 

    Questions for Session 2 Assignment

    Due: Wednesday, September 10, 2025, 10:00 AM
  • 

    Recording for Session 2: Human Subjects Protection File
  • 

    Slides for Week 2: Human Subjects Protection File

• Week 3: Thursday, September 18, 2025- The Scientific Protocol Review Process at MSK and other NCI Designated Cancer Centers
  • Instructor(s): Alexia Iasonos, PhD, Dana E. Rathkopf, MD and Mark A. Dickson, MD     

    • Research Council
    • Other Committees
  • 

    Questions for Session 3 Assignment

    Due: Wednesday, September 17, 2025, 10:00 AM
  • 

    Slides for Session 3: The Scientific Protocol Review Process at MSK and other NCI Designated Cancer Centers File
  • 

    Recording for Session 3: The Scientific Protocol Review Process at MSK and other NCI Designated Cancer Centers File

• Week 4: Thursday, September 25, 2025- Investigational New Drug and Data & Safety Monitoring Committees
  • Instructor(s): Alan L. Ho, MD, PhD and Susan F. Slovin, MD, PhD

    • INDC
    • IDE
    • Data Safety Monitoring Committee (DSMC)
  • 

    Questions for Session 4 Assignment

    Due: Wednesday, September 24, 2025, 10:00 AM
  • 

    Slides for Week 4: Investigational New Drug and Data & Safety Monitoring Committees File

    Dr. Alan Ho's slides on INDC

  • 

    Slides for Week 4: Investigational New Drug and Data & Safety Monitoring Committees File

    Dr. Susan Slovin's Slides on DSMC

  • 

    Recording for Week 4: Investigational New Drug and Data & Safety Monitoring Committees File

• Week 5: Thursday, October 2, 2025- Logistics of Enrolling Patients – Reducing Barriers to Clinical Trials
  • Instructor(s): Lisa Diamond, MD, MHS, MPH

    • Discuss common barriers to accruing patients to clinical trials that represent the general population
    • Outline best practices in ensuring accessibility of participation in clinical research to all

  • 

    Questions for Session 5 Assignment

    Due: Wednesday, October 1, 2025, 10:00 AM
  • 

    Recording for Session 5: Logistics of Enrolling Patients – Reducing Barriers to Clinical Trials File
  • 

    Slides for Session 5- Logistics of Enrolling Patients – Reducing Barriers to Clinical Trials File
  • Some interesting articles on the topic that were referenced in the Q&A portion. The latter is from NCI and has links to other resources on the topic.

    
    

  • 

    Article #1- How do doctors explain randomised clinical trials to their patients? URL
  • 

    Article #2- Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials URL

• Week 6: Thursday, October 9, 2025- Subject Safety
  • Instructor(s): James J. Harding, MD

    • Common Terminology Criteria for Adverse Events (CTCAE)
    • Reporting serious adverse events (SAEs)
    • Documenting adverse events 
  • 

    Questions for Session 6 Assignment

    Due: Wednesday, October 8, 2025, 10:00 AM
  • 

    Recording for Session 6: Subject Safety (2021 Lecture) File
  • 

    Slides for Week 6: Subject Safety (2021 Lecture) File

• Week 7: Thursday, October 16, 2025- Sponsor – Investigator Relationships and Responsibilities
  • Instructor(s): Gregory J. Riely, MD, PhD and Erika McCarthy

    • Agreements and contracts
    • Investigator responsibilities including review of the 1572
    • Sponsor responsibilities including auditing and monitoring
    • Research Privacy
    • Conflict of Interest

  • 

    Questions for Session 7 Assignment

    Due: Wednesday, October 15, 2025, 10:00 AM
  • 

    Slides for Session 7: Sponsor – Investigator Relationships and Responsibilities (Riely) File
  • 

    Slides for Session 7: Sponsor – Investigator Relationships and Responsibilities (McCarthy) File
  • 

    Recording for Session 7: Sponsor – Investigator Relationships and Responsibilities File

• Week 8: Thursday, October 23, 2025- The Patient’s Perspective
  • Moderator: Annie Ellis 

    • Patient Advocacy
    • Patient Experience 

  • 

    Questions for Session 8 Assignment

    Due: Wednesday, October 22, 2025, 10:00 AM
  • 

    Slides for Session 8- The Patient’s Perspective File
  • 

    Recording for Session 8- The Patient’s Perspective File

• Week 9: Thursday, October 30, 2025- Securing Multidisciplinary Support and Multimodality Studies
  • Instructor(s): Michael Offin, MD, Himanshu Nagar, MD, Edmund Bartlett, MD and Yingbei Chen, MD, PhD  

    Moderator: Carly Ryan

    • Conducting Collaborative Studies
      • Tips for working with physicians outside of your field
      • Effective communication and collaboration
      • Getting buy in from co-investigators
      • Avoiding and dealing with conflict                                                         
    • Securing Support for Multimodal studies
      • Pharmacy

    • Radiology                                                                                             
    • Lab Medicine
    • Other
  • 

    Questions for Session 9 Assignment

    Due: Wednesday, October 29, 2025, 10:00 AM
  • 

    Slides for Session 9: Securing Multidisciplinary Support and Multimodality Studies File
  • 

    Recording for Session 9: Securing Multidisciplinary Support and Multimodality Studies File

• Week 10: Thursday, November 6, 2025- Conduct of the Trial Part I
  • Instructor(s): Gregory J. Riely, MD, PhD and Ruth Ann Gordon, MSN, FNP-BC, OCN®

    • The roles of the investigator
    • Plans for research rigor and integrity
    • Eligibility
    • Creating attainable and reasonable deliverables when writing the protocol 

  • 

    Questions for Session 10 Assignment

    Due: Wednesday, November 5, 2025, 10:00 AM

• Week 11: Thursday, November 13, 2025- Conduct of the Trial Part 2
  • Instructor(s): Gregory J. Riely, MD, PhD and Marlon S. Lasa-Blandon

    • Training and best practices (regular meetings with staff and sponsor(s)
    • Project management and delegation
    • Meeting deliverables in the protocol
    • Amendments

  • 

    Questions for Session 11 Assignment

    Due: Wednesday, November 12, 2025, 10:00 AM

• Week 12: Thursday, November 20, 2025- Multicenter Trials
  • Instructor(s):  Michael J. Morris, MD and Mary Warren

    
    

  • 

    Questions for Session 12 Assignment

    Due: Wednesday, November 19, 2025, 10:00 AM

• Week 13: Thursday, December 4, 2025- Effective Documentation and Corrective and Preventive Action Plan Reviews
  • Instructor(s): Karima Yataghene, MD

    • Real-time documentation
    • Consent and reconsent
    • Electronic Documentation and 21 CFR Part 11 Compliance
    • Reporting deviations
    • Tools
    • Regulatory Binders 
  • 

    Questions for Session 13 Assignment

    Due: Wednesday, December 3, 2025, 10:00 AM

• Week 14: Thursday, December 11, 2025- Financial Accountability
  • Instructor(s): Kevin Frodell, Elena Lascu and Barry Zakrzewski

    • Budgeting
    • Medicare and research
    • Funding resources
    • Research billing 
    • Reviewing Corrective and Preventive Action response to audits

  • 

    Questions for Session 14 Assignment

    Due: Wednesday, December 10, 2025, 10:00 AM

• Week 15: Thursday, December 18, 2025- FDA Regulations
  • Instructor(s): Richard Ellis         
    

  • 

    Questions for Session 15 Assignment

    Due: Wednesday, December 17, 2025, 10:00 AM