ITHS Clinical Research Center Resource Usage Application Forms

If you are new to ITHS, please review Getting started with ITHS Clinical Research Center Resources.

Use the following forms to apply to use resources at the:

• Adult Clinical Unit at the UW Medical Center
• Pediatric Clinical Unit at Seattle Children's Hospital

Submit your completed application to ithsapps@u.washington.edu (regardless of which CRC facility you will be using).  Incomplete applications will not be reviewed.

Note: if your study proposal involves research subjects under 14 years of age (with the exception of infants who are involved in a study of their mothers), then you must apply through the Pediatric CRC so that the Clinical Research Center Network Scientific Review Committee (Children’s) may review your study, regardless of where you plan to perform your research.  

For applications to UW Clinical Research Center:

• Review the  application checklist.

• IRB application* (completed draft copy acceptable) - Note that you can submit your application before you receive approval from your IRB.

• Protocol including any supplemental information providing basic requirements (e.g. statistical design, sample size).
  The ITHS requires a protocol for every study so that clinical staff (nurses, techs, etc.) can understand the procedures a subject will experience, research procedures can be performed to the investigator's specifications, and so consent requirements can be met accurately. Sample study protocol template.

• Data and Safety Monitoring Plan Form (DSMP)^*

• Consent/assent form(s) (draft copies acceptable)

• Prior Scientific Review Form - use this form if requesting exemption from Center for Scientific Review (CSR) review

• UW ITHS Services Form including relevant appendices:
  

  • Appendix 1 – Utilization of Facilities/Services
  • Appendix 2 – Nursing Services
  • Appendix 3 – Nutrition, Body Composition, Bioenergetics and Exercise Research Services
  • Appendix 4 – Biomedical Informatics Services
  • Appendix 5 – Gene and Cell Therapy Services
  • Appendix 6 – Psychometry Services (Children’s CRC only)
  • Appendix 7 – Clinical Research Associate Support Core Services (Children’s CRC only)

For applications to Seattle Children's Research Institute:

• Protocol including any supplemental information providing basic requirements (e.g. statistical design, sample size).
  The ITHS requires a protocol for every study so that clinical staff (nurses, techs, etc.) can understand the procedures a subject will experience, research procedures can be performed to the investigator's specifications, and so consent requirements can be met accurately. Sample study protocol template.

• Data and Safety Monitoring Plan Form (DSMP)^*

• Consent/assent form(s) (draft copies acceptable)

• Prior Scientific Review Form - use this form if requesting exemption from Center for Scientific Review (CSR) review

• Seattle Children's Combined IRB-ITHS Application - This form incorporates the ITHS Services Form and appendix 1 & 2.  You must still complete relevant appendices 3-7:

  • Appendix 3 – Nutrition, Body Composition, Bioenergetics and Exercise Research Services
  • Appendix 4 – Biomedical Informatics Services
  • Appendix 5 – Gene and Cell Therapy Services
  • Appendix 6 – Psychometry Services (Children’s CRC only)
  • Appendix 7 – Clinical Research Associate Support Core Services (Children’s CRC only)

* Note: Investigators using the Fred Hutchinson Cancer Research Center IRB do not need to submit this form as appropriate DSMP information is already solicited as part of the IRB application.