Routing and Approvals
A University institutional official (IO) reviews every sponsored project proposal to ensure adherence to all 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.
Most clinical research projects are subject to Food and Drug Administration (FDA) regulations and human subject protection laws. The SeRA (Stanford Electronic Research Administration) system captures department, PI and Research Management Group (RMG) approvals through the Proposal Development and Routing Form (PDRF). The PDRF must be completed and approved prior to contract execution and study activation.
How to Obtain or Route Approvals
The Clinical Trial Associate (CT Assoc.) initiates the PDRF in the SeRA system and reassigns it to the Clinical Trial Research Process Manager (CT RPM). Once the clinical trial budget is negotiated with the sponsor, the CT RPM routes the PDRF through SeRA to the department approvers, the PI and any other Stanford faculty who will devote effort to the project. The PDRF captures required compliance information, including Conflict of Interest, export control, the European General Data Protection Regulation (GDPR), PI training, as well as the project’s financial details. A clinical trial contract may not be signed until the PDRF has been fully routed and approved.
Clinical Trial Contract Officers (CT COs) are authorized to sign clinical trial agreements on behalf of the University.
The PI or study coordinator submits the IRB and Scientific Review Committee (SRC) applications to the IRB and SRC for review and approval. A clinical trial agreement 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).