Clinical Trial Information

To contract for a clinical trial

We will need the following before we can execute a clinical trial agreement:

  • Submit Funding Proposal to OSP using RAMS-SPOT
  • Itemized budget, e.g., Sample Clinical Trial Worksheet
  • Complete FCOI in AIRS System
  • Western IRB submission package - we will need two copies of the entire package, and a third copy of the Initial Submission Form, the Informed Consent Form, and the title page of the protocol (click here for WIRB forms). We may need additional information depending upon whether or not the sponsor agrees to pay WIRB directly.

As you begin the process -

  • Be sure you use the appropriate F&A (also referred to as indirect cost, or overhead) rate before presenting a budget to a company: review the definition of “Clinical Trial” that qualifies a study for the 30% industry rate, or discuss your project with us first.
  • Provide us with a proposal/protocol. Some sponsors may require that your proposal be submitted through our Office. If not, you can expedite the process by submitting the proposal directly to the sponsor and sending a copy to us.
  • Provide us with the company’s contact information.
  • Let us know if you would like help with the budget. See “Tips on preparing a clinical trial budget.”

VCU requires that investigators and key personnel complete the Collaborative IRB Training Initiative (CITI) Basic Course in either Biomedical or Social-Behavioral Research. If you have not yet done so, please click here for more information about the nature of the program and about registering to gain access.

To contract for an investigator-initiated study

We will need the following before we can execute a research agreement:

As you begin the process-

  • Be sure you use the appropriate F&A rate before presenting a budget to a company: review the definition of "Clinical Trial" that qualifies a study for the 30% industry rate, or discuss your project with us first.
  • Provide us with a proposal. Some sponsors may require that your proposal be submitted through our Office. If not, you can expedite the process by submitting the proposal directly to the sponsor and sending a copy to us.
  • Provide us with the sponsor’s contact information.
  • Let us know if you would like help with the budget. If the study is a "Clinical Trial" review “Tips on preparing a clinical trial budget.”

To get help finding a funding opportunity-

  • Contact our office to discuss your research goals.
  • Provide the names or types of companies you’re aware of that might benefit from the results of your research.
  • Provide us with a brief description of your research interests and your thoughts about potential commercial applications.

We will-

  • Contact companies that might be interested in your research, and provide them with an introduction to your research and its potential commercial applications;
  • Facilitate the scheduling of further discussions between you and company representatives;
  • Facilitate interaction with any other University offices as applicable (e.g., Office of Technology Transfer, Office of Research Subjects Protection); and
  • Execute the necessary confidentiality and research agreements.

Other Helpful Tips

Fixed & Administrative (F&A) Costs

The F&A rates for industry-funded research are the same as for federally-funded research (see the DHHS Rate Agreement for the different categories), with the exception of industry-funded clinical trials. If your study falls under the definition of clinical trial [A clinical trial is a study designed to assess in humans the safety, efficacy, benefits, adverse reactions, and/or other outcomes of drugs, devices, diagnostics, treatments, procedures, medical evaluations, monitoring, or preventive measures. To qualify for the clinical trial F&A rate-

  1. the study must meet the clinical trial definition given above;
  2. the study must be fully supported by an industry sponsor; and
  3. a contract meeting University requirements for industry-supported clinical trials must be executed with the sponsor.]

then the F&A rate is 30% of the total direct cost.

Be sure you have used the correct F&A rate in your budget before presenting the budget to the company. Having to go back to the company and explain why the budget needs to be increased will delay execution of an agreement and may result in a complete loss of support from the company.

With rare exceptions, VCU will not reduce or waive F&A costs on industry-funded projects. One exception is the case where the funding entity has a published maximum F&A rate.

WIRB

Do not send WIRB submissions directly to WIRB. They must come through OIP. If you send the submission directly to WIRB, they will shelve it and may or may not tell VCU they've received it. WIRB considers the study open at the site until a study closure report is received. Please complete the study closure form when:

  1. All subjects have finished their final visits and follow-up and
  2. The sponsor or sponsor representative has indicated the study is closed at your site and
  3. If the study was conducted under a Federalwide Assurance, all data analysis at the site is completed.

WIRB will close the study upon receipt of the closure report.