The primary purpose of the Saint Louis University School of Medicine clinical trials office is to improve efficiency and encourage coordination of research efforts between clinical departments. To achieve this, the office:
- Facilitates processing of contracts and budgets through standardized policies and procedures.
- Provides training and education to clinical research personnel.
- Acts as an informational resource for all research personnel including coordinators, investigators and business managers.
- Coordinates with Tenet Hospital around approval processes, with particular attention to Medicare analysis and other required regulatory activities.
To accomplish its goals, the clinical trials office at Saint Louis University, with appropriate departmental input, will:
- Act as the office of record for all contract documents.
- Track the projects and contracts.
- In consultation with departments, negotiate the terms of the contract.
- Provide assistance with budget preparation and negotiation, if needed, prior to approval.
- Assist with compliance regarding research issues.
- Collect data for internal and external audit purposes.
- Coordinate amendments and contract terminations.
- Provide assistance to departments in the preparation of paperwork for studies.
- Maintain an informational website.
- Provide training and education to departmental research personnel and principal investigators.
- Create standard operating procedures for the administration of clinical trials.
- Provide final signature of agreements and proposals.
As the clinical trials office develops, the range of functions and operations that it can deliver may evolve in conjunction with input from departments, as well as University administrative units. Regardless of any changes in structure, the office is committed to working closely with University investigators and other research personnel in order to optimize clinical research operations across the School of Medicine.