Statements (32)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:parliamentary_committee
|
| gptkbp:abbreviation |
gptkb:DMC
DSMB |
| gptkbp:alsoKnownAs |
Data and Safety Monitoring Board
|
| gptkbp:composition |
statisticians
clinicians independent experts ethicists |
| gptkbp:features |
access to unblinded data
|
| gptkbp:guidelinesBy |
gptkb:ICH
gptkb:FDA gptkb:EMA |
| https://www.w3.org/2000/01/rdf-schema#label |
Data Monitoring Committee
|
| gptkbp:importantFor |
protects participant welfare
protects trial integrity |
| gptkbp:makesRecommendationsOn |
early stopping for efficacy
early stopping for futility early stopping for safety trial modification |
| gptkbp:meetingPlace |
periodically during trial
|
| gptkbp:originatedIn |
clinical research
|
| gptkbp:purpose |
monitor safety and efficacy data during clinical trials
|
| gptkbp:reportsTo |
steering committee
trial sponsor |
| gptkbp:requires |
many regulatory agencies
|
| gptkbp:role |
ensure participant safety
recommend trial continuation or termination review interim data |
| gptkbp:usedIn |
clinical trials
medical research |
| gptkbp:bfsParent |
gptkb:Pfizer_COVID-19_vaccine_trial
|
| gptkbp:bfsLayer |
7
|