Template Image
CTA Processing News
The College of Medicine's RAC Office is now responsible to negotiate and finalize for signature all CTA's and related CTA documents such as Non-Disclosure Agreements (NDA), for College of Medicine faculty. RAC will work closely with the HSC Clinical Trial Compliance Office. All other CTA's are directed to DSR in Grinter Hall.
To help manage this new activity in RAC, DSR has assigned and located Anthe Hoffmann, Assistant Director of Research in the RAC Office. Anthe will train and guide the RAC staff to become Clinical Trial Agreement Specialists. Anthe will provide DSR signature onsite for those College of Medicine CTA's.
CTA Processing Guide:
-
The Principal Investigators (PI) or PI staff should provide College of Medicine RAC Office or DSR's Proposal Processing Office, as appropriate with a copy of the proposed CTA, study letter if Master CTA is being used, a copy of the protocol, Clinical Trial Checklist, and a company contact person as early in the process as possible. These items maybe delivered to;
-
RAC using Peoplesoft Grants Workflow
-
DSR at ufproposals@ufl.edu
-
-
DSR and RAC can begin review, but prefer to begin negotiating with the sponsor when the completed CTA checklist is received. The CTA checklist provides critical information about the trial that is needed in order to finalize the CTA or study letter terms and conditions.
-
The CTA or study letter cannot be signed by UF until the completed Sponsored Projects Approval Form (DSR-1) or Peoplesoft Grants equivalent is received at DSR, as well as any other appropriate information which would be conveyed to the PI by DSR or RAC during negotiations.
-
IRB approval is not necessarily required for DSR to execute an agreement, but certainly is required prior to commencing work under the CTA or study letter.
-
Once the terms of the CTA or study letter have been negotiated and all other required documents are on file, DSR will sign the CTA or study letter and return it to the company contact, unless otherwise directed.
If the Investigator's signature is needed to acknowledge the terms of the CTA or study letter, DSR or RAC will collect such signature prior to signing and returning the agreement to the company.
-
For clinical trials remaining in Fund 209, DSR will continue to release budget equal to cash received, with an NOA.
For clinical trials moving or being established in the newly created Fund 214 for industry sponsored clinical trials, DSR will issue a NOA upon full execution of the agreement and IRB approval. A 214 project will be established at $0. As payments are received at the Office of Research Clinical Trial Business Unit and a trial project identified, 80% of the cash will be released into the project for spending with the other 20% released to the DSR indirect cost project for end of year distribution.
Read more about Fund 214 Procedures and Responsibilities.
Non-Disclosure/Confidentiality Agreement Processing Guide
Non-Disclosure Agreements (NDA) and/or Confidential Disclosure Agreements (CDA) are usually prerequisites to a Clinical Trial. For example a pharmaceutical company or a coordinating contract research office (CRO) may want to send a clinical research protocol to the investigator so they can decide whether or not to participate in the trial. Prior to receipt of such a document a NDA/CDA needs to be executed by both parties. For the protection of the University and Investigators involved, all NDA/CDA's must be reviewed, approved and executed by the legal authorities at the Division of Sponsored Research (DSR).
To process your NDA/CDA for DSR's approval, please follow the steps below.
-
Send the NDA/CDA you receive to the RAC Office or DSR's Proposal Processing Office, as approriate. If to DSR send to ufproposals@.ufl.edu. If you do not have the agreement electronically you may fax or hand carry to DSR.
-
Include the name, address, telephone number and email address of your contact.
-
Please inform us of any concerns you may have about the NDA/CDA.
-
RAC for College of Medicine faculty and DSr for others will review the agreement, negotiate the terms (if needed), collect DSR signature and return it to the other party. If the Investigator's signature is needed to acknowledge the terms of the agreement, RAC or DSR will collect such signature prior to signing and returning the NDA/CDA to the company.
-
Once DSR receives a fully executed NDA/CDA, a copy will be sent to the Investigator and the exchange of confidential information can begin.