Data Safety Monitoring Board (DSMB) Charter

Purpose

The Data Safety Monitoring Board (DSMB) provides independent oversight of research integrity, data quality, and ethical compliance within the WeCASOR network.

The DSMB ensures that research conducted under WeCASOR maintains scientific rigor and participant protection standards.

Scope

The DSMB:

• Reviews study protocols
• Reviews adverse event trends (if applicable)
• Evaluates data integrity signals
• Assesses risk-benefit balance in future interventional phases
• Recommends continuation, modification, or suspension of studies if necessary

Composition

The DSMB should include:

• Independent neurologist or stroke specialist
• Biostatistician
• Ethics expert
• Health systems researcher
• Optional external advisor (international)

Members must:

• Have no direct operational role in data collection
• Declare conflicts of interest annually

Responsibilities

• Quarterly review of data summaries
• Review of protocol deviations
• Review of safety indicators (if interventional phase begins)
• Documentation of meeting minutes
• Written recommendations to Program Director

Authority

The DSMB may recommend:

• Study continuation
• Study modification
• Temporary suspension
• Escalation to governance review

Final implementation authority remains with institutional leadership.