Clinical Trial Agreements (CTAs) require signatures from both the trial sponsor and a University institutional official (IO) with signature authority delegated by the Board of Trustees of the Leland Stanford Junior University. Within the Research Management Group (RMG), Clinical Trial Contract Officers (CT CO) who have achieved the appropriate certification level serve as IOs for CTAs and have the authority to commit the institution to the terms and conditions of the agreement. PIs, study team members, hospital personnel, and others may not sign CTAs on behalf of the University. However, the Principal Investigator (PI) usually signs the CTA in acknowledgment that he or she has read the agreement.
How to Obtain Contract Signatures
Prior to signing a CTA, a CT CO verifies that the following approvals have been completed for all studies:
- Proposal Development Routing Form (PDRF) in SeRA (Stanford Electronic Research Administration) system; and
- Institutional Review Board (IRB) approval.
In addition, specific studies may require the following approvals:
- Scientific Review Committee (SRC) approval for cancer studies;
- Medicare Preauthorization for device studies; or
- Risk Assessment Committee (RAC) approval for PI-initiated studies.
Types of Signatures
The University accepts all types of document signatures, but prefers that all documents be signed electronically through AdobeSign or DocuSign. If a sponsor requires, Stanford will sign with original signatures and transmit a PDF document via email to the sponsor. In rare cases, sponsors may require wet-ink signatures to be signed and sent by U.S. mail.
As a first step, the CT CO sends the final, un-executed CTA to the PI for signature. The CT CO signs next and returns the document to the sponsor for signature. Finally, the sponsor returns a fully-executed agreement to the CT CO.
Once the CT CO receives the fully-executed CTA, s/he issues an Award Approval Notification (AAN) through the SeRA system to initiate account set-up. The SeRA system distributes a copy of the award and the fully-executed CTA to the PI and the department.