The process for establishing NDAs or CDAs for clinical trial agreements follows these steps:
- Identifying the Need – A need for an NDA arises when a sponsor, collaborator, or university investigator anticipates sharing confidential information related to a potential clinical trial. This is typically identified at the initial discussion stage.
- Initial Contact – The sponsor or collaborator contacts the University to discuss the potential clinical trial and the requirement for an NDA.
- Drafting the NDA – The sponsor usually provides the initial draft. If the University initiates the NDA, the contract team drafts it using University-approved templates.
- Submission in RAMP – A University administrator uploads the NDA request into RAMP to track the agreement and initiate internal review.
- Contract Review – Both the sponsor’s and the University’s contract teams review the NDA to ensure compliance with institutional policies and regulations. At UW-Madison, this involves RSP (Office of Research and Sponsored Programs) for any agreements that are routed through RAMP.
- Negotiation – If revisions are necessary, both parties negotiate terms until they reach a mutually acceptable agreement. The updated agreement is uploaded to RAMP and routed for final approval and signature from RSP.
- Signing – Authorized representatives from both the sponsor and the University sign the NDA. The executed agreement is uploaded into RAMP for recordkeeping. The agreement remains accessible in RAMP for reference throughout the collaboration.
- Implementation – Once the RAMP record is marked “active,” the University may share confidential information with sponsor as permitted under the NDA.