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Clinical research projects conducted at Rady Children’s Hospital

When conducting research with:

  • Rady Patients
  • Rady Patient Data
  • Rady Services
  • Rady Facilities

a Ready to Accrue (RTA) Letter must be obtained from Rady Children’s Research Administration before the study can begin. 

 

Steps to RTA:

  1. Submit your project request through Rady Children’s Cayuse application. You will be able to identify what Rady Services your project will require (if any). Rady Children’s Research Administration will review your submission and create a task list for you and your research team.

    • If you don’t have access to Rady Children’s Cayuse Application, contact research@rchsd.org for direction and access.

    • Your project will route to your division chief for review and approval  

  2. Contact your UCSD pre-award Fund Manager. 

    • For industry initiated clinical trials, email the Fund Manager the sponsor provided Protocol, Clinical Trial Agreement draft, Clinical Trial Budget draft, Informed consent forms, and IRB # (preferred). The pre-award Fund Manager will create the Kuali Research record and route to OCTA for contract terms review & negotiation and OCAA for budget negotiations with the sponsor.

    • For investigator initiated studies, contact your pre-award Fund Manager to assist with the proposal submission. They will establish a Kuali Research Record, assist with budget development and route the Kuali record to the institutional official for review and submit the proposal to the sponsor.

  3. Note: The pre-award Fund Manager will discuss budget with Rady Research Administration for investigator initiated clinical trials and UCSD OCAA will reach out to Rady Research Administration for cost on industry initiated clinical trials.

  4. The Rady Children’s RTA will be issued when:

    • All compliance matters are approved (e.g. IRB, Conflict of Interest).

    • UCSD has executed the award and issued the chart-string.

    • Purchase Order (for investigator initiated studies) or Purchased Service Agreement (for industry initiated clinical trials) has been issued to Rady.

    • Ancillary agreements, such as Material Transfer or Data Use Agreements (as needed) are executed.