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Assign membership into BFO/OBI branches. Biological marker (CDISC) Study populations (CDISC) Trial coordinator (CDISC) Study variable (CDISC) Drug (RCT) Subject (MUSC). Study. Case report form (CDISC) Patient file (CDISC) Consent form (CDISC) New drug application (MUSC)
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Biological marker (CDISC) Study populations (CDISC) Trial coordinator (CDISC) Study variable (CDISC) Drug (RCT) Subject (MUSC)
Case report form (CDISC) Patient file (CDISC) Consent form (CDISC) New drug application (MUSC) Investigational new drug application (MUSC)
Development plan (CDISC) Standard operating procedures (CDISC) Statistical analysis plan (CDISC) Meta-analysis (CDISC) Quality assurance (CDISC) Quality control (CDISC) Baseline assessment (CDISC) Validation (CDISC) Coding (MUSC) Permuted block randomization (MUSC) Secondary-study-protocol (RCT) Intervention-step (RCT) Blinding-method (RCT) Study design
Negative findings (MUSC) Positive findings (MUSC) Primary-outcome (RCT) Secondary-outcome (RCT)