Instructors:

Susan Ellenberg, Scott Evans, Matt Downs, Frank Rockhold

10:00 – 1:00 Part 1

Introduction (Frank Rockhold)

Topic 1: Why are we here? Background on the IDMC development (Susan Elllenberg)

Topic 2: Basic Responsibilities of IDMCs and their membership (Susan)

Ensuring the ongoing safety of study participants
• Ensuring that the study quality is such that results will be meaningful
• Meeting these responsibilities requires understanding protocol,data collection process and statistical analysis plan
• Careful regular Review of IDMC Report Content

Topic 3: IDMC Charters and Member Contracts (Susan)

• What is a Charter and what should it include
• Need for flexibility in Charters
• Contracts addressing Conflict of Interest and Indemnification
• Relationship between IDMC, Sponsor, Executive Committee, CRO
• Who should talk to whom?

11:45-12:00. Break

Topic 4 What does a sponsor need to know about IDMCs and SDACs? (Scott Evans)

• Size and expertise of IDMC membership
• Selecting the Chair
• Conflict of interest considerations
• Frequency of meetings
• Government vs Industry variations
• Regulatory Expectations
• Maintaining sponsor independence of the IDMC and the SDAC
• To whom does the IDMC report

Topic 5 Structure of IDMC Meetings (Scott)

• Open and closed sessions
• IDMC Deliberations
• Updates on other trials of the sponsor
• Importance of comprehensible, concise and well-organized report

1:15 – 4:15 Part 2

Topic 6 Role of the SDAC (Matt Downs)

Role of the Independent Statistcian
 Participation in development of the IDMC Charter & Development of a SAP tailored to the needs of the IDMC
 Understanding the protocol and data collection / case report forms
 Data Reports

Content of an IDMC report
• The open report
• The closed report
• Presentation style with emphasis on graphics, clarity, and conciseness

SDAC interactions
• the IDMC during meeting
• the IDMC Chair outside of meetings
• the Sponsor
• Which SDAC members should attend the IDMC meetings

Meeting Logistics

• Taking Minutes of IDMC meeting
• Organizing TC & Web Conferences
• Securely sending out interim IDMC Reports

2:45-3:00 Break

Topic 7: Case Studies Review. (Susan and Scott)