The Clinical Trials Office provides a wide range of services for clinical trials supported by federal and foundation grants, industry contracts, including investigator-initiated trials.
CTO responsibilities for projects include:
- Coverage analysis development (if applicable, please refer to the following guidance)
- Budget development and negotiations for industry-sponsored clinical trials
- Informed consent form cost and reimbursement language review
- Registry into Saint Louis University Clinical Trials Management System, Clinical Conductor
- Patient services bill review
- Financial oversight of industry-sponsored clinical trials
- Oversight of ClinicalTrials.gov postings
The CTO requires the following documents to be submitted into eRS to initiate the review:
- Draft Informed Consent Form
- Draft Study Agreement
- Draft Study Budget
- Study Feasibility Form - (must be logged into SLU ID to access)
Other documents that may be required include:
- Investigators brochure (drug trials)
- FDA IND Letter of Approval (for experimental drugs showing promise in clinical testing)
- FDA IDE Letter of Approval (investigational device exemption or IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.)
- IFU Instructions for Use or user instruction manual (medical devices)
If your study involves utilizing the services of other departments with Saint Louis University and/or SSM Health affiliated hospitals, please contact the respective departments (e.g. Radiology, Pathology, Pharmacy) to ensure proper assessments of the costs involved.
The CTO offers personalized meetings with investigators and study teams to explain the services and procedures.