Table 5.

Studies with adequate accrual (recruitment)

Description	What proportion of studies recruited and retained the number of subjects required to analyze their primary research question. Operational Definitions: Adequate Recruitment: ◦ Numerator: # of subjects recruited for study ◦ Denominator: # of subjects needed by the eligible study based on either 1) power analysis or 2) original grant proposal
Rationale	Studies not meeting the number will have insufficient statistical power to complete their analyses.
Inclusion/Exclusion	Inclusion: NIH-funded, human subjects clinical research studies that are closed to recruitment (studies may still be collecting data or conducting analyses) Exclusion: studies with corporate/non-federal funding; those using only qualitative methods; multi-site studies
Possible Descriptive Data to Collect	Type of review: exempt/non-exempt/full board review Length of time study open for enrollment: <6 months; 7–11months; 12–13; 24+ Type of study: clinical trial; observational/survey Type of population: Pediatric only; Adult only Disease/condition studied: need to determine what would be the relevant groups Minority accrual targets: were there explicit minority accrual targets established (yes/no)
Data Source	Grant proposal; IRB protocol submission; IRB progress reports
Scoring	Identifies the method used to score the measure	Rate
Unit of Analysis	Data will be collected at a protocol level and aggregated to the institution-level
Comments: