Clinical Trials Administrative Start-Up Handbook

SECTION 6

Flow Chart Illustrating the General Clinical Research Center Process




TABLE OF CONTENTS General Information Best Practices for Developing the GCRC Budget Best Practices for Completing the Scientific Advisory Committee (SAC) Application Administrative Start-up Checklist Key Contacts Timeline

General Information

In September of 2007, the University of Washington was awarded a grant from the National Institutes of Health (NIH) to establish an Institute for Translational Health Sciences (ITHS). Such grants, awarded competitively to various academic institutions, are intended to facilitate translation of medical science from the laboratory to the clinic, "transforming how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients." As part of the ITHS, researchers in the Seattle metropolitan area will be connected by a Clinical Resarch Centers Network (CRCN) that will include sites at the UW, Children's Hospital and Regional Medical Center (CHRMC), the Benaroya Research Institute (BRI) at Virginia Mason, and the VA Clinical Research Unit, with specialized facilities at the Fred Hutchinson Cancer Research Center (FHCRC).

The UW ITHS Web site is under development. For the next few months (until January or February, 2008), please consult the existing General Clinical Research Center (GCRC) Web site for:

• Step-by-step guidance about submitting applications to use the GCRC facilities, both at the UW and at CHRMC, and
• Comprehensive information about services available to investigators, such as assistance with regulatory issues, biostatistics, data and safety monitoring plans, data management, protocol writing, research tool development, and more.

As currently configured, the GCRC has two locations: 1) adult studies are conducted at the University of Washington Medical Center (UWMC), and 2) pediatric studies are conducted at CHRMC. Patient beds at both locations are separate from, but contiguous to, clinical care wards. The beds are available for use in inpatient and outpatient clinical studies, either sponsored or unsponsored.

To use GCRC facilities or staff at either location, investigators must apply to and receive approval from the appropriate Scientific Advisory Committee (SAC). Both SACs evaluate proposals on scientific merit and assign priorities for the use of GCRC resources. The SAC application forms, including instructions for completing the form, can found at the Applications tab on the GCRC Web site.

Using the GCRC requires careful adherence to the procedures and standards established by the NIH grant that supports the Centers. Each GCRC application becomes part of a future competitive grant submitted to the NIH for a continuation of funding, and therefore all applications are reviewed with rigor.

With review, approval, and prioritization by the SAC, the GCRCs may be used both for clinical trials that have been designed and initiated by the investigator and for clinical trials that have been designed and initiated by a pharmaceutical company. Responsibilities for cost coverage will vary depending on several factors which need to be discussed in advance with the GCRC administrator. Discussions about cost coverage will center on the research category ("A," "B," or "D") into which your study falls. Research categories are defined and explained on the GCRC Web site under Submit an Application.

Best Practices for Developing the GCRC Budget

• For industry-sponsored studies, be sure to work with CRBB to develop an acceptable budget prior to submitting a budget to the sponsor and prior to submitting your application to the SAC. Cost discussions are important because: 1) industry sponsors are responsible for all costs associated with Category D protocols, and 2) the SAC application requires that you demonstrate adequate financial resources to conduct the study.

Best Practices for Completing the SAC Application

• Visit the GCRC Web Site. It is full of valuable information, including annotated application forms, flowcharts, links to other resources, how-tos, and much more.
• Take advantage of the GCRC's offer to help you do it right. Use the Investigator Assistance tab to find out more about help that is available to you.
• Be sure that the completed SAC application can stand alone, without references to other documentation such as the IRB application, the research grant, or the sponsor's protocol.
• Along with your application, be sure to submit copies of your research protocol and consent/assent forms. If you need help with writing a protocol, use the protocol template at the GCRC Web site.
• Time your proposal: Note the GCRC deadlines and the SAC meeting schedule (see Key Contact and Timeline).

Administrative Start-up Checklist
SAC/GCRC

Click to Download Checklist in Word

Key Contact

University of Washington
Box 356178
Phone: 206-598-4700
Fax: 206-598-2890

Children's Hospital and Regional Medical Center
Mail stop: W-6605
Phone: (206) 987-3897
FAX: (206) 987-5160

Timeline

Completed applications must be submitted to the UWMC GCRC by the first of the month. Applications are reviewed by the SAC on the third Thursday of the month.

Completed applications must be submitted to the CHRMC Pediatric CRC by the 10th of the month. Applications are reviewed by the SAC on the first Thursday of the following month.