Getting started with ITHS Clinical Research Center Resources

You must complete an application process before you can do research in one of the CRCs. In the future, we plan to have a centralized process to use any of these centers. For now, researchers applying to use the UW Adult CRC or Seattle Children's Pediatric CRC should use the following process, while researchers at other centers must contact the center directly for application forms.

Have you used ITHS services before?  You may jump directly to the ITHS Services Application Forms.

Process:

  1. Consult with ITHS
  2. Complete the application
  3. Submit the application for review
  4. Await application review and approval
  5. Submit post-review changes

1. Consult with ITHS

Let us help you make your application a success, starting with your protocol and budget. Please consult with ITHS early in the process--before you apply to make use of our Clinical Research Centers.

Ways we can help:

  • Budget assistance - Effective 5/20/08, all grant proposals that intend to utilize ITHS nursing, nutrition, and body composition services at the UW will need to include costs for these services. To obtain estimated costs, please complete the appropriate templates below and send it as an attachment to ITHSfees@u.washington.edu with at least 10 days lead time. You will receive an estimated budget, including applicable subsidies, suitable to submit with your grant proposal within 10 working days of submitting the template.
  • A Statistical Consult - can help with the design of your study. Our biostatistician will help give your study its best chance at producing solid evidence to elucidate your scientic questions.
  • A Biomedical Informatics Consult can help answer specific biomedical data management questions including data integration, database design, or data sharing.
  • A Regulatory Support and Bioethics Consult can help you assess your protocol and put together a Data and Safety Monitoring Plan and navigate complex regulatory issues. 
  • Additional Consults - Planning to use resources from any of our specialized scientific cores? Contact the cores as early as possible, ideally while you're preparing your primary grant application. 

2. Complete the application

You must complete an application process before you can do research in one of the CRCs. In the future, we plan to have a centralized process to use any of these centers. For now, researchers applying to use the UW Adult CRC or Seattle Children's Pediatric CRC should complete the ITHS Services Application Forms, while researchers at other centers must contact the center directly for application forms.

This application is required so that you may receive the ITHS subsidy, and so that we may allocate resources effectively--critical were the resource to become over-utilized.  You will be asked to submit your IRB approval for the study, your study protocol, and a short resource utilization form.

Note that your study must undergo scientific review if it has not done so already.  Read more about scientific review including a list of approved review committees.

Which CRC should I apply To?

Normally, you should apply to the center where you plan to see subjects. However, 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 (CRCN) Scientific Review Committee (Children’s) may review your study, regardless of where you plan to perform your research.  Your application, however, should still be directed to ithsapps@u.washington.edu.

Requirements for industry-sponsored studies

The CRCN can be used for industry-sponsored studies. Industry-sponsored studies are those studies with a for-profit organization sponsoring the study. The for-profit organization is expected to pay for the use of ITHS facilities at the same rates that it would pay for any hospital bed or clinic usage and ancillary charges at the CRC used. ITHS member discounts do not apply. Investigators who are receiving industry support for projects conducted in the UW CRC must be free to publish or distribute data from such studies without restriction.  At Children's, Phase II and III trials require commitment by the Sponsor that the investigators will be allowed to publish the results regardless of the outcome of the trial.

All industry-sponsored projects are subject to the same requirements and levels of review as described on this page.

3. Submit the application for review

The CRCN reviews new applications monthly. Submit complete applications by the 25th (UW) or 10th (Children's) in order to be reviewed for the upcoming month.  Reviews occur on the 1st Thursday of the following month for Children’s; 3rd Thursday for the UW. Missing or incomplete materials could delay review of your study.

From the time of submission of your application to receipt of notification of study start is approximately 3 weeks. If your study qualifies for administrative approval notification can occur within 24 hours of application submission.

To initiate the application process regardless of which CRC facility you will be using, submit your completed application to ithsapps@u.washington.edu.

4. Await application review and approval

Prior to the CRCN Scientific Review Committee meeting, the resource utilization portions of your application will be reviewed by the unit Medical Director and applicable core directors or designees. If these reviewers have questions or concerns about the application, they will likely contact you or your designated study staff to resolve them. Decisions are usually sent out within a week of the CRCN Scientific Review Committee meeting (sooner if no scientific review is required). There are four possible decision outcomes:

  1. Approved: The materials are approved as submitted with no modifications required. When an application is approved, we will provide you with instructions on the next steps for getting your study activated and up and running.
  2. Approved with contingencies: The application is approved with contingencies that require modification to the materials submitted, or a formal response to questions posed by one or more reviewers. You have 90 days to prepare and submit your response. Responses are typically reviewed in an expedited fashion and do not normally require re-review by the CRCN Scientific Review Committee. You will be informed if full-committee review is required.
  3. Tabled: The CRCN Scientific Review Committee or resource reviewers have determined that there are significant concerns or outstanding information sufficient to preclude an adequate evaluation of the application. A tabled application must be resubmitted and if CRCN Scientific Review Committee review is required, standard submission deadlines will apply.
  4. Disapproved: The proposed study lacks sufficient scientific merit or requires resources or support beyond those available within the CRCN and/or ITHS.

The decision letter may also include two additional results of the review:

  1. Post-approval clarifications: Clarifications include items or questions that do not impact the approvability of the study but must be resolved prior to activation of the study (e.g. the protocol says a pregnancy test will be performed but doesn’t specific whether it will be blood or urine).
  2. Further recommendations: Recommendations are suggestions that do not require a response or revision to the application in order to activate the study. However, if you decide to implement any recommendations that result in revisions to your protocol or IRB approval please be sure to submit a copy of the final revised documents.

If you have any questions or concerns regarding the outcome of your review please don’t hesitate to contact us.

5. Submit any post-review changes

Requests for changes to core services and/or an increase in the number of subjects must be reviewed and approved prior to implementation at the CRC. Read more about post-review changes.

Last modified: January 6, 2010