Institutional Approvals and Setting up Study Accounts

An University Institutional Official (IO) reviews every sponsored project Proposal & Award to ensure adherence to government, University and School of Medicine policies.

Examples of compliance requirements include: Principal Investigator (PI) eligibility, human subjects training, Institutional Review Board (IRB) review and approval and Conflict of Interest Declaration. The PI is responsible for assessing and addressing all applicable regulatory approvals for the study.

For Industry Sponsored Clinical Trials, the SeRA (Stanford Electronic Research Administration) System system captures department, PI and Research Management Group (RMG) approvals through the Clinical Trial Proposal Development and Routing Form (CT PDRF). The CT PDRF must be completed and approved prior to contract execution and study activation.

CT PDRF

Clinical Trial Research Process Managers (CT RPMs) are authorized to approve a budget within a CT PDRF on behalf of the University after negotiations have been completed for industry-initiated studies or prior to negotiations for PI-I studies.

Contract Signatures

Clinical Trial Contract Officers (CT COs) are authorized to sign Clinical Trial Agreements (CTAs) on behalf of the University.

Regulatory Approvals

The PI or study coordinator submits the protocol to the IRB and if required, to the Administrative Panel on Biosafety (APB) for review and approval. A CTA may not be signed until approvals have been granted.

SeRA Award and Account Set-Up  

A contract must be fully executed before the CT CO can issue an Award Acceptance Notification (AAN). The CT CO prepares and issues the AAN in SeRA. Then, the SeRA system generates a transaction for setting up the account known as a Project Task Award (PTA). After completion of the PTA Setup Transaction, the SeRA system automatically generates a Notice of Award (NOA).