As part of a clinical trial, Stanford may wish to engage outside entities to perform specific parts of a protocol or act as an additional site. For example, if a Principal Investigator (PI) has written a protocol and obtained industry support to conduct a study, the PI may engage another institution to act as a study subsite in order to collect additional patient data. Or, Stanford may engage another institution or organization to perform an intellectually significant portion of the statement of work under a sponsored project. In each of these instances, the PI must obtain sponsor approval to initiate a Subaward. Subwards require a formal, written agreement between the parties and an expenditure of sponsored research funds to an outside entity.
CT RMG Clinical Trial Contract Officers (CT COs) negotiate and sign Subawards for industry-sponsored clinical trials. CT RMG follows Stanford policies on Subawards, as outlined in the Research Policy Handbook, Section 16.
How to Process a Clinical Trial Subaward
- The PI determines that a Subaward for a clinical trial is required, identifies a subrecipient, and submits the following documents through iProcurement:
- Scope of work or protocol that the subrecipient must peform, proposed timelines, and deliverables;
- Subrecipient’s budget, including the per-patient costs and total budget amount;
- OSR Form 33, completed and signed by the subrecipient;
- Notation that the request is a clinical trial Subaward with industry funding that should be processed by CT RMG; and
- Sponsor approval of the subrecipient.
- The Office of Research Administration (ORA) receives the Subaward request through iProcurment and then submits the request for Subaward execution to CT RMG for assignment.
- CT RMG assigns the request to a CT CO to review and prepare a Subaward agreement.
- The CT CO negotiates the Subaward with the subrecipient and ensures receipt and documentation of all necessary approvals.
- The CT CO is responsible for obtaining signatures from the subrecipient, the PIs on the study, and signs the agreement for Stanford.
- After the Subward is executed by all parties, the CT CO issues the subaward in SeRA.