data safety monitoring board
GPTKB entity
Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Committee
|
| gptkbp:advocacy |
ensure informed consent is maintained
|
| gptkbp:analysis |
perform data analysis for safety assessments
|
| gptkbp:clinical_trial |
influence clinical trial design decisions
|
| gptkbp:clinical_trial_transparency |
promote clinical trial transparency
|
| gptkbp:collaboration |
collaborate with clinical investigators
|
| gptkbp:committee |
often referred to as data monitoring committee (DMC)
|
| gptkbp:community_health |
contribute to public health safety
|
| gptkbp:composed_by |
may include statisticians, clinicians, and ethicists
|
| gptkbp:composed_of |
independent experts
|
| gptkbp:confidentiality_agreements |
may require confidentiality agreements for members
|
| gptkbp:conflict_of_interest |
must disclose any conflicts of interest
|
| gptkbp:data_privacy |
maintain confidentiality of trial data
|
| gptkbp:ethical_oversight |
provide ethical oversight of clinical trials
|
| gptkbp:evaluates |
efficacy of interventions
|
| gptkbp:frequency |
periodically during trial
|
| gptkbp:function |
monitor safety of clinical trials
|
| gptkbp:goal |
ensure participant safety
|
| gptkbp:has_a_focus_on |
participant safety and data integrity
|
| gptkbp:has_advisory_board |
serve in an advisory role to sponsors
|
| https://www.w3.org/2000/01/rdf-schema#label |
data safety monitoring board
|
| gptkbp:impact_on_trial |
can significantly impact trial outcomes
|
| gptkbp:independence |
must be independent from trial sponsors
|
| gptkbp:interim_analysis |
conduct interim analyses of data
|
| gptkbp:is_reviewed_by |
review data at predetermined intervals
|
| gptkbp:meeting_minutes |
document meeting minutes and decisions
|
| gptkbp:monitoring_duration |
throughout the duration of the trial
|
| gptkbp:monitoring_plan |
develop a monitoring plan for trials
|
| gptkbp:provides_guidance_on |
follow established guidelines for operation
|
| gptkbp:publications |
may publish findings after trial completion
|
| gptkbp:recommendation |
continue, modify, or stop trials
non-binding but influential |
| gptkbp:recommendations_based_on |
recommendations based on data analysis
|
| gptkbp:recommendations_communicated_to |
trial sponsors and regulatory bodies
|
| gptkbp:regulatory_compliance |
required by regulatory agencies
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_management |
assist in risk management strategies
|
| gptkbp:safety_measures |
conduct safety assessments regularly
|
| gptkbp:safety_signals |
identify safety signals during trials
|
| gptkbp:side_effect |
analyze adverse event reports
|
| gptkbp:stakeholders |
engage with stakeholders throughout the trial
facilitate communication with stakeholders |
| gptkbp:terminate_trials |
can recommend termination of trials if necessary
|
| gptkbp:training |
members may require training in clinical trial monitoring
|
| gptkbp:trial_integrity |
ensure trial integrity is maintained
|
| gptkbp:trial_phases |
can be involved in multiple trial phases
|
| gptkbp:bfsParent |
gptkb:VEGF_Trap-Eye_Study
gptkb:TRIBUTE_study |
| gptkbp:bfsLayer |
6
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