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Research-Related Injury

Topics

Whom to Contact
What Types of Studies
How to Initiate
IRB Application
Budgets

Getting Started On Your Clinical Trial

The Clinical Trials Office (CTO) is part of the Office of the Vice President for Research and External Relations. We serve investigators in all colleges of the University.

How do I know whom to contact about my research?

All human subjects research carried out at the University or under its auspices must be reviewed by an IRB. Projects that have external support must also be reviewed by one of the following University offices, depending on the source of support:

• Government, foundations, or voluntary health agencies — Division of Sponsored Programs
• Corporations — CLINICAL TRIALS OFFICE

All contracts — whether they are research study agreements, confidentiality agreements, or whether they go by any other title — must be made between the University of Iowa and the corporate entity. Only authorized officials of the University have the authority to sign contracts, the Director of the Division of Sponsored Programs and the University's Business Manager.

What types of studies are handled by the Clinical Trials Office?

The CTO processes studies that are supported by industry and involve evaluation of a technology or product such as a drug, surgical procedure, medical device, vaccine, diagnostic test or technique. Included are the following:

• Pre-clinical studies (in vitro or animal models) with a direct linkage to planned human studies
• Clinical studies (human subjects) including but not limited to Phases I — IV clinical trials

Different types of contracts may be needed depending on the nature or phase of the research.

How do I initiate a clinical trial/contract?

In order to review a new study, the CTO needs the following:

• Contract (all copies, whether signed or not)
• Protocol
• Budget
• Name, phone and address information for a sponsor contact
• UI proposal routing form (accessed online)

The review process will not begin until the CTO has received the above items, which includes a fully signed UI proposal routing form. Please note that the budget does not need to be finalized in order to submit a routing form.
Send the above items to Clinical Trials Office, 201 Gilmore Hall; or fax if appropriate to 319-335-2104, or email to clinical-trials@uiowa.edu.

What about the IRB application?

Although the review process in the CTO is independent of the IRB process, a new study cannot begin until both offices have approved it (with the exception of a preclinical study which involves no human subjects). The ideal timing is to submit both applications simultaneously to the respective offices. That way, both offices can be working on your study in parallel, and both the contract and the IRB approval are likely to be completed at about the same time.

Beginning on November 1, 2005, Western IRB (WIRB) will be the IRB of record for all corporate-sponsored clinical trials (with a very few exceptions such as PI-initiated studies). Marty Barrows will coordinate the process of sending the initial application to WIRB. Please see the Human Subjects Office site to learn about submitting to WIRB.

If you will be submitting an invoice to the sponsor for WIRB review-fee payment, there is a template available here. This can be pasted into departmental letterhead.

What about the budget?

Learn about working with budgets in the next section of the site.

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