Discussions may involve the study goals and aims, the methodology, statistical and regulatory considerations, subject recruitment, schedule of assessments, study interventions, or other components of the study. The goal is to identify potential barriers to successful study completion and to propose solutions.
Experts will provide an evaluation and recommendations on the budget as it relates to the proposed study, including estimates for the overall study budget, site/subject budget, and a recruitment budget, if applicable.
Recommendations on timelines for application submission and for the overall study conduct, including planning, study start-up, subject accrual, closeout, and final publication, will be evaluated.
A feasibility assessment and recommendations to optimize successful study completion within the proposed timelines and budget.