The Data Safety Monitoring Boards - Data Monitoring Committees Management Handbook

TABLE OF CONTENT

Introduction p.5
DMC and DSMB p.5
Data Monitoring Committee (DMC) p.5
Data Safety Monitoring Board (DSMB) p.5
Other monitoring committees p.5
Steering Committee p.5
Ethics Committee (EC) p.6
Institutional review board (IRB) p.6
Endpoint Adjudication Committee (EAC) p.6
Clinical event committee (CEC) p.6
General rules applying to DMC p.6
Which studies need a DMC? p.6
Responsibilities of the DMC p.7
Structure of a DMC p.7
composition p.7
qualification p.7
Independence p.7
Number of members p.7
Roles p.8
members training and education p.8
members substitution p.8
members management p.8
members consensus attitude p.9
The DMC Charter p.9
Software & Data management p.10
Software p.10
Software selection p.10
User Requirements Specifications (URS) p.10
Software validation (acceptance tests) p.10
Software training p.10
Software integration p.10
Data Management p.10
Type of data p.11
Interim data monitoring p.11
Statistical methods p.11
Unblinding p.11
Transparency p.11
Processes p.11
Standard operating procedures and confidentiality agreements p.12
Selection of the DMC p.12
Charter preparation p.12
Charter revision p.12
DMC meetings p.12
Kick-off meeting p.12
Frequency of dmc meetings p.13
Open sessions p.13
Closed sessions p.13
Executive closed sessions p.13
Discussion and Voting p.13
DISAGREEMENT MANAGEMENT p.13
Review reports and FORMS p.14
Open session report p.14
Closed session report p.14
Immediater action report p.14
Form definition p.14
STUDY CLOSURE p.14
SOP Definition p.14
AUDIT TRAIL p.14
Content definition p.14
Formats definition p.15
DATA / METADATA ARCHIVING p.15
SOP p.15
Validation p.15
Glossary p.15
Bibliography p.16