Description
The course provided the knowledge and operational skills necessary to develop, implement, and manage a clinical trial including budget and contract negotiations, clinical trial site evaluation and selection, marketing and advertising for recruitment, and project management, audits and reporting.
Objectives
Objectives
- Evaluate the impact of study phase and design as it impacts clinical trial operations and compliance with Good Clinical Practice Guidelines.
- Appraise the methods for selecting and evaluating potential clinical trial sites
Compare and contrast the roles and responsibilities of the clinical research site and sponsor/monitor. - Analyze standard research industry contracts including form, function, and issue.
- Generate a plan for clinical trial enrollment, recruitment, and retention of study.
- Compose an operational implementation timeline including procedures for FDA audits and reporting, cash flow analysis, and study closure procedures.
- Communicate the plans to bring an investigative site/PI into compliance with FDA.
- Synthesize the key components from a clinical trial for post-study reporting and dissemination of clinical trial results.
