This course will cover and train the students:
1. The process of coordinating and managing a clinical study from the perspective of day-to-day operations of a clinical research study, from planning site logistics and constructing timelines for the study-initiation visit to closing out a study.
2. The course will focus on the operational, interpersonal, and data-management aspects of the process: Act as the main source of communication between site and sponsor. Evaluate trial sties for participation. Follow study plans (e.g. monitoring plan, communication plan). Obtain/verify vendor credentials (e.g. lab certification/licensure)
3. Sample/diagnostic collection, shipment verification, reporting and storage requirements. Verify equipment calibration and maintenance. Ensure proper collection, processing, and shipment of specimens (e.g. centrifuge, preparation of slides, freezing, refrigeration)
4. Monitor appropriate staff, facility, and equipment availability throughout the study: Identify issues and recommend investigatory/site corrective actions. Ensure adequacy of investigational product/device and associated supplies and ensure proper storage, dispensing, handling and disposition of investigational equipment and supplies use and maintenance
5. Study timelines
6. Subject responsibilities for study participation
7. Contracts and budgets (e.g. subject compensation, site payment)
8. Subject compliance assessment: Assess subject compliance. Re-evaluate the recruitment strategy as needed.
9. Subject responsibilities for study participation
10. Contracts and budgets (e.g. subject compensation, site payment)
Course Description
The process of coordinating and managing a clinical study from the perspective of day-to-day operations of a clinical research study, from planning site logistics and constructing timelines for the study-initiation visit to closing out a study.
Key concepts covered include:
- Clinical Research Site Management
- Monitoring
- Preparation of Study Documents, Study Monitoring Plan, Checklist for IMV, SIV, PSSV and COV
- Developing Site – CRA relationship
- Site Communication and Protocol Management
