Investigator Initiated Clinical Trial Agreements
The following documents are required when Investigator Initiated Clinical Trials are
submitted to OGCA for review, negotiating and processing:
- UAB Extramural Checklist (must provide a realistic deadline date, not ASAP)
- Agreement / Contract (Paper and electronic version)
- Sponsor Contact Information Form
- Protocol – as submitted to the IRB / WIRB
- Informed Consent Form
- Sponsor Budget and internal budget (detailed NIH type budget)
- CIRB forms
- Copies of all FDA – required documentation
- UABRF – IP disclosure Form
Form and instructions http://www.uab.edu/images/UABRF/IPDForm032008.pdf
- IRB or IACUC approval
Notes to Investigators
Investigators acting as sponsors are held to the same standard and obligations as any other
individual or organization that takes responsibility for and initiates a clinical investigation.
Investigator responsibilities include complying with FDA regulations and guidelines,
such as filing for an IND. The FDA determines the exemption status, i.e. IND or non-
IND, after investigator submission of FDA Form 1571. For a comprehensive list of these
requirements please refer to the Code of Federal Regulations, 21 CFR Part 312.
FDA 1571 Form
Statement of Investigator Form FDA 1572
When negotiations are finalized with the sponsor, agreements are then:
- Routed to Legal and UAB Research Foundation for review
- Routed to the PI for signature
- Routed for the Institutional signature
- Mailed to the sponsor for signature unless IRB or CIRB has a hold on it.
- Fully executed agreements are sent to the PI, the Department Contact, the
Award Manager and Grants and Contracts Accounting.
SIGNED CONTRACTS CANNOT BE RELEASED FROM OGCA WITHOUT IRB and CIRB APPROVAL
New Clinical Trials Indirect Cost Rate – Effective January 1, 2008
The Clinical Trials Indirect Cost Rate, for sponsor-initiated and investigator-initiated, on-
site and off-site, has been harmonized to 26% total direct costs.
To qualify for the Clinical Trials Indirect Cost Rate of 26%, a contract, budget and its
associated protocol must meet seven criteria. The following criteria will be used by
OGCA to determine the applicability of the Clinical Trial Indirect Cost Rate:
1. The study involves the systematic investigation in a human population of
the effects of an experimental drug, treatment regimen, or device for a
particular disease or disorder according to a formal protocol.
2. The sponsor agrees:
to indemnify UAB
to negotiate invention rights in accordance with UAB policy
to obtain consent to use UAB’s name
to allow publication by UAB
3. Budgets identify anticipated pricing and support costs; however, spending
of the award by budget category is not required.
4. The agreement does not include an audit provision.
5. There is limited financial accountability to the sponsor and there is no
requirement to return funds to the sponsor.
6. Uniform pricing is used, based upon the number of patients enrolled,
number of trials completed, number of exams, etc. as monitored in
accordance with UAB policy.
7. There are no subcontracts.
The new rate does not apply retroactively to existing agreements or to those agreements
where all of the following have been met:
• the budget has been negotiated and submitted to OGCA
• the contract has been submitted to OGCA,
• the Conflict of Interest Disclosures have been submitted to the CIRB
• the Human Subjects protocol is under review by the IRB/WIRB
All other existing policies associated with clinical trials remain in effect. Please
apply the 26% rate as you develop budgets for all pending clinical trials to insure that
they will comply with the new rate on or after January 1, 2008. Investigators with
questions about the applicability of the new rate should contact Jane Fant for
clarification of the policy and applicability of the rate.
*** ANY CLINICAL TRIAL PROPOSED THAT DOES NOT MEET THE 7
CRITERIA ABOVE WILL BE CLASSIFIED AS A STANDARD GRANT OR
CONTRACT AND THE APPROPRIATE FULL INDIRECT COST RATE
BASED ON MODIFIED TOTAL DIRECT COSTS WILL APPLY. ***