Health Science Center
Clinical Trial Agreements and Confidentiality Agreements
For Dentistry, Nursing, Pharmacy, PHHP, and Veterinary Medicine
The College of Medicine Research Administration and Compliance (COM RAC) now negotiates all Clinical Trial
Agreements (CTAs) and Confidentiality/Non-Disclosure Agreements (CDA/NDA) for the Health Science Center
(HSC).
Notification of a CTA or a CDA/NDA should be sent via the COM RAC Listserve at: COM-RESEARCH-ADMIN-COMP-
L@LISTS.UFL.EDU.
The steps below will help to assure timely negotiations of these agreements and review of all required compliance
documents by the COM RAC staff:
FOR CDA/NDAs: Please submit request for CDA/NDA review to the COM RAC Listserv with the following: a Word doc
or PDF of the draft CDA/NDA; the Sponsor contact name, email, phone, fax, and relevant emails. COM RAC staff will
send the fully executed CDA/NDA to Department contact persons, the PI, or others as requested.
FOR CTAS:
1. If the HSC College creates the CTA proposal in PeopleSoft (PS), please complete the following:
a. On the header page, mark the “Purpose” as CLIN (for clinical trial).
b. Include the Sponsor contact information: Contact name, phone, fax, email, physical address, and courier account
number (e.g., Fed Ex or UPS) if available.
c. Upload all appropriate contract and compliance documents for review: CTA draft, Protocol, Clinical Trial Checklist,
and RAC compliance packet with applicable forms.*
If PS is not used, please provide to the COM RAC Listserve: a signed DSR1, CTA draft, Protocol, Clinical Trial
Checklist, RAC compliance packet with all applicable forms*, and Sponsor contact, phone, fax, email, physical
address, and courier account number (e.g., Fed Ex or UPS) if available.
2. A final budget for the CTA must be negotiated by PI/Study Team and Sponsor and approved by the HSC College
before the COM RAC liaison can negotiate and finalize the CTA for signatures by DSR and the Sponsor. Notice of a final
approved budget can come to COM RAC in two ways: 1) the PI/Study Team uploads final budget in PS with approval at
Dean’s level, and email notice to COM RAC Listserv; or 2) the Dean’s office emails the final approved budget to the COM
RAC Listserve.
NOTE: Before DSR signs the CTA, the COM RAC liaison will confirm with the PI/Study Team that the CTA contains the
final budget and correct payment terms. RAC and DSR do not negotiate budgets or check and approve the fiscal
feasibility of a study.
3. COM RAC staff will review compliance documents for completeness and correctness and will issue a required
Financial Language Assessment (FLA) form and a Study Initiation Letter (SIL) with appropriate billing and subject injury
language. The COM RAC liaison will email notice of approval to the HSC Department staff and will send the approved
compliance forms to the College and Department--either by email or through PS. With a final budget and compliance
review completed, the COM RAC liaison can negotiate the CTA draft to final approval by both Sponsor and DSR. Note:
The compliance review and a limited draft review of the CTA can begin simultaneously, but the CTA remains open for
negotiations until all compliance processes are complete.
Note: The FLA process takes 5 business days from the time COM RAC receives a complete and correct compliance
packet.
*The RAC compliance packet includes the Study Registration Initiation Checklist (SRIC), with all applicable attachments --
for example, device and/or drug tables, final negotiated budget, Confirmation of Services (COS), Medicare Coverage
Checklist, Protocol, draft/final ICF to WIRB or UF IRB, and CTA draft. The forms can be found on our website:
http://ctc.health.ufl.edu/freqUsed/freq_used_forms.shtml .