Statements (58)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:academic
|
| gptkbp:aimsTo |
ensure validity
maximize reliability minimize bias |
| gptkbp:alternativeName |
Clinical_Trial_Design
clinical_trials_registry randomized_controlled_trial |
| gptkbp:documentedIn |
clinical trial protocol
clinical trial registry |
| gptkbp:hasType |
gptkb:clinical_trial
observational study adaptive design crossover design double-blind design factorial design non-randomized trial open-label design parallel group design single-blind design |
| https://www.w3.org/2000/01/rdf-schema#label |
clinical trial
|
| gptkbp:involves |
informed consent
blinding control group endpoint selection ethical approval exclusion criteria inclusion criteria intervention assignment placebo randomization sample size calculation statistical analysis plan study protocol |
| gptkbp:regulates |
gptkb:EMA_guidelines
gptkb:ICH-GCP FDA guidelines local ethics committees |
| gptkbp:relatedTo |
gptkb:clinical_trial
|
| gptkbp:requires |
data analysis
data collection quality assurance adverse event reporting data monitoring outcome measurement follow-up procedures participant recruitment protocol adherence reporting results statistical power |
| gptkbp:usedIn |
drug development
behavioral intervention assessment medical device evaluation |
| gptkbp:bfsParent |
gptkb:James_Lind
gptkb:RAND_Health_Insurance_Experiment gptkb:Sequential_Medical_Trials gptkb:ClinicalTrials.gov gptkb:FX-322_Phase_2a |
| gptkbp:bfsLayer |
5
|