data safety monitoring board
GPTKB entity
Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Committee
|
| gptkbp:bfsLayer |
4
|
| gptkbp:bfsParent |
gptkb:VEGF_Trap-Eye_Study
|
| gptkbp:advocates_for |
ensure informed consent is maintained
|
| gptkbp:analysis |
conduct interim analyses of data
perform data analysis for safety assessments |
| gptkbp:clinical_trial |
can be involved in multiple trial phases
can recommend termination of trials if necessary can significantly impact trial outcomes influence clinical trial design decisions promote clinical trial transparency |
| gptkbp:collaborations |
collaborate with clinical investigators
|
| gptkbp:committee |
often referred to as data monitoring committee (DMC)
serve in an advisory role to sponsors |
| gptkbp:composed_of |
independent experts
may include statisticians, clinicians, and ethicists |
| gptkbp:conflict |
must disclose any conflicts of interest
|
| gptkbp:court |
ensure trial integrity is maintained
|
| gptkbp:data_privacy |
maintain confidentiality of trial data
may require confidentiality agreements for members |
| gptkbp:duration |
throughout the duration of the trial
|
| gptkbp:focuses_on |
participant safety and data integrity
|
| gptkbp:frequency |
periodically during trial
|
| gptkbp:function |
monitor safety of clinical trials
|
| gptkbp:goal |
ensure participant safety
|
| gptkbp:healthcare |
contribute to public health safety
|
| https://www.w3.org/2000/01/rdf-schema#label |
data safety monitoring board
|
| gptkbp:independence |
must be independent from trial sponsors
|
| gptkbp:is_evaluated_by |
efficacy of interventions
|
| gptkbp:is_monitored_by |
develop a monitoring plan for trials
|
| gptkbp:is_reviewed_by |
review data at predetermined intervals
|
| gptkbp:meets |
document meeting minutes and decisions
|
| gptkbp:provides_information_on |
follow established guidelines for operation
|
| gptkbp:publishes |
may publish findings after trial completion
|
| gptkbp:recommendation |
continue, modify, or stop trials
non-binding but influential recommendations based on data analysis trial sponsors and regulatory bodies |
| gptkbp:regulatory_compliance |
required by regulatory agencies
provide ethical oversight of clinical trials report findings to regulatory agencies |
| gptkbp:reports_to |
sponsor of the trial
|
| gptkbp:responsible_for |
review adverse events
|
| gptkbp:result |
issue a final report at trial completion
|
| gptkbp:risk_factor |
assist in risk management strategies
|
| gptkbp:safety_features |
conduct safety assessments regularly
identify safety signals during trials |
| gptkbp:side_effect |
analyze adverse event reports
|
| gptkbp:social_responsibility |
facilitate communication with stakeholders
|
| gptkbp:sponsor |
engage with stakeholders throughout the trial
|
| gptkbp:training |
members may require training in clinical trial monitoring
|