Clinical Studies Contract Negotiation Process
An approved agreement is required for the following types of clinical studies:
- Investigator Initiated
- Cooperative Agreements
- Industry Sponsored
- Foundation Sponsored
- Grant Funded
1. Principal Investigator submits study registration request in KC+, including the following required elements:
- Institutional Review Board (IRB) Number
- Final Protocol
- Budget Template
- Risk Questionnaire
- Data Elements Assessment Questionnaire
2. The Clinical Trials Center of Excellence Team reviews the request for completeness, routing the appropriate components to the following concurrent steps as appropriate:
- WVU Medicine approves Coverage Analysis and approves budget
- Risk Assessment
- Clinical Trial Agreement (CTA) Negotiation (not required for internal investigator initiated studies); will be facilitated through KC+ negotiation module
- Data Elements Assessment and Data Use Agreement Negotiation
3. Clinical Trials Center of Excellence approves request with the following required elements:
- Successfully negotiated Clinical Trial Agreement
- Finalized Data Use Agreement (DUA)
- Finalized Risk Assessment
4. CTA Execution
5. Study Activation (pending independent Institutional Review Board approval process)
**Timeline for activation is dependent upon sponsor response time.**