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

  1. The PI determines that a Subaward for a clinical trial is required, identifies a subrecipient, and submits the following documents through iProcurement:
    1. Scope of work or protocol that the subrecipient must peform, proposed timelines, and deliverables;
    2. Subrecipient’s budget, including the per-patient costs and total budget amount;
    3. OSR Form 33, completed and signed by the subrecipient;
    4. Notation that the request is a clinical trial Subaward with industry funding that should be processed by CT RMG; and
    5. Sponsor approval of the subrecipient.
  2. 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.
  3. CT RMG assigns the request to a CT CO to review and prepare a Subaward agreement.
  4. The CT CO negotiates the Subaward with the subrecipient and ensures receipt and documentation of all necessary approvals.
  5. The CT CO is responsible for obtaining signatures from the subrecipient, the PIs on the study, and signs the agreement for Stanford.
  6. After the Subward is executed by all parties, the CT CO issues the subaward in SeRA.