The CDA must be reviewed and executed by the Office of Research Contracts (ORC). CDAs are executed by the University to cover all Duke personnel involved in the research project. Learn more.
Receipt of Protocol/Budget Regulation Packet from Sponsor
After site selection, the sponsor will send a Study Start-Up packet, including the documents necessary to meet regulatory obligations. These documents are needed to start the development of the ICA/Budget so please forward them to your CRU ARPM upon receipt. Learn more.
The feasibility assessment, contract and budget negotiation, and IRB submission and institutional approval processes are performed in parallel to avoid delays in institutional approval and begin enrollment earlier.
- IRB: The PI is responsible for submitting a new study application to the IRB and to receive IRB approval before human subject research can begin. Learn more.
- CTA Negotiation: The Clinical Trial Agreement (CTA) or contract is sent to the Office of Corporate Research and Collaborations. This office is responsible for the contract negotiation for all points except the budget. The contract is not finalized until the budget negotiations are complete. Learn more.
- ICA Development: For financial feasibility, the Finance Practice Manager (FPM) or designee will review the protocol and other study-related documents to develop an Internal Cost Assessment (ICA). An ICA is required and must be reviewed and approved by the responsible CRU.
- Budget Negotiation: A successful clinical trial will include a budget that adequately meets the financial needs of conducting a trial. Since costs vary for supplies and services, budgets are almost always negotiable. Sponsors usually use one of two options when presenting a budget. They may offer a certain amount per patient and ask that you work within that amount or they may ask the PI to formulate a budget for them. Regardless, it is the PI’s responsibility to ensure that the amount agreed upon will adequately cover all costs associated with conducting a clinical trial.
Start up/Activation Enrollment
Start up of clinical trials involves many steps. Learn about clinical trial recruitment, enrollment, obtaining informed consent, outpatient research appointment scheduling, research billing, source documentation, case report forms, shipping of samples, and compensation for subjects. Learn more.
When all study activity is complete at a site, the study must be closed. Learn about study closure and record retention.