Clinical Trials Administrative Start-Up Handbook

SECTION 6

Flow Chart Illustrating the Clinical Research Center Process




TABLE OF CONTENTS General Information Best Practices for Developing the CRCN Budget Best Practices for Completing the ITHS Application Best Practices for Using the ITHS Facilities 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."

The ITHS is a "collaboratory" that aims both to establish and sustain cooperative networks of translational researchers and to have a multi-institutional research impact. In the Seattle metropolitan area, the collaboratory core is the Clinical Research Centers Network (CRCN), consisting of locations where translational researchers can see subjects for research purposes. Beyond the metropolitan area, the ITHS collaboratory extends to the clinical and research infrastructure developed by the University of Washington across the five-state WWAMI region: Washington, Wyoming, Alaska, Montana, and Idaho.

Information about ITHS membership is available at the ITHS Web site. Any investigator may complete an application for either the "member" or "scholar" level, enabling full access to ITHS resources.

The UW ITHS Web site is an excellent and ever-expanding resource. Browse it for start-up information about:

• Step-by-step guidance for submitting research applications to use the various ITHS resources, including the clinical research facilities at the UW Adult CRC and at the Seattle Children's Hospital Pediatric CRC, and
• Comprehensive information for services available to investigators, such as consultation about regulatory and bioethics issues, biostatistics, data and safety monitoring plans, data management, protocol writing, research tool development, research education and training, connecting with research partners, and more.

As currently configured, CRCN beds 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.

Using the CRCN facilities requires careful adherence to the procedures and standards established by the NIH grant that supports the centers. Each application to use one of the CRCN facilities 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 CRCN Scientific Review Committee, the CRCN facilities 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 and are referenced briefly below under "Best Practices for Developing the CRCN budget."

Best Practices for Developing the CRCN Budget

• For studies at both the UW Adult CRC and the Children's Hospital PCRC, responsibilities for and levels of cost coverage will vary depending on several factors, e.g., whether you (the investigator) are an ITHS member and whether your study is investigator-initiated, industry-sponsored, or industry-initiated. For more information, refer to the following Web sites and/or discuss these factors in advance with the appropriate CRC contact people.
  
  
  • For specific information about the UW Adult CRC, refer to information about developing a budget and about applicable fees.
  • For specific information about the Children's Hospital PCRC, refer to information about developing a budget and about applicable fees.
    
    
• Use the CRBB Decision Tree (scroll down to "Process and Resources") as a guide when budgeting for studies at the UW Adult CRC.. Remember that ITHS and CRBB staff, regardless of which office you consult first, will provide coordinated budget advice and information that is tailored to your study.

Best Practices for Completing the ITHS Application

• Visit the ITHS 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 ITHS's offer to help you do it right. Use the various tabs from the ITHS Web pages to find out more about help that is available to you.
• Complete and submit all portions of the ITHS Clinical Research Center Usage Application Forms. Do not omit the study protocol. The study protocol must be a stand-alone document (not the study description section of your IRB application). If you do not have a study protocol and need help developing one, refer to the ITHS sample study protocol template and/or call the ITHS staff for advice.
• Time your proposal: Note the ITHS deadlines and the CRCN Scientific Review Committee meeting schedule (see Key Contact and Timeline). Remember that missing or incomplete application materials could delay review of your study.

Best Practices for Using the ITHS Facilities

• Remember to schedule a study implementation meeting with CRC staff prior to enrolling your first subject.
• Remember that all investigators, including faculty at the UW who do not have Seattle Children's Hospital MD privileges, must qualify to conduct research at the Pediatric CRC. Call 206-987-5216 for more information about this requirement.

Key Contacts

University of Washington
Box 356178
Phone: 206-616-9195
Fax: 206-616-9250

Seattle Children's Hospital
Mail stop: W-6605
Phone: (206) 987-3897 (for scheduling)
Phone: (206) 987-3084 (for budget information)
FAX: (206) 987-5160

Timeline

The Scientific Review Committees - both at the UW and at Seattle Children's Hospital - review new applications monthly.

At the UW: Submit new applications by the 25th of the month so that it can be reviewed on the third Thursday of the following month, e.g., submit by June 25th to be reviewed on the third Thursday in July.

At Seattle Children's: Submit new applications by the 10th of the month so that it can be reviewed first Thursday of the following month, e.g., submit by June 10th to be reviewed on the first Thursday in July.

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