Clinical Trial Agreement Checklist
Principal Investigator’s Name:
UPN/PS Number:
Subject:
Trial Sponsor:
Protocol Number:
This CTA Checklist is a required document that must be submitted to DSR. The information being
collected by this form will help DSR negotiate an acceptable Clinical Trial Agreement (CTA).
I.
Clinical Trial Category: Please indicate whether this is an investigator initiated study or a
sponsor initiated study by checking the appropriate box below.
□ Investigator Initiated: Protocol has been developed by UF Principal Investigator and/or
other UF personnel or in collaboration with the Sponsor.
□ Sponsor Initiated: Protocol has been developed solely by Sponsor and/or Sponsor’s
Agent(s) with no involvement of UF Principal Investigator and/or other UF personnel.
II. VA Involvement: Please indicate the following concerning the VA by checking the appropriate
box below.
□ Yes, this clinical trial will be supported by the VA or conducted at a VA facility or target
VA subjects.
□ No, this clinical trial will not be supported by the VA or conducted at a VA facility or target
VA subjects.
III.
Services Payment/Consideration: Please identify which of the following payment scenarios
apply to this clinical trial project by checking one appropriate box below from Option #1-5. If
there are exceptions, limitations or variations to the Option checked, complete Option 5B also
and explain. Choose Option #6A only if none of the choices below apply.
For additional assistance, review the document entitled: Use the Following in Completing
the Clinical Trial Agreement Checklist.
Note: Services Payment/Consideration language is not related to Subject Injury language.
□ Option 1
Sponsor will pay for all services provided under this protocol, including study-related
medical services and routine, standard-of-care medical services, if any, and no claims
will be submitted to patients or third party payors for any services associated with the
study.
□ Check here and prov