OHSU

OHSU Investigators & Staff

Welcome OHSU Investigators & Research Staff!

The Clinical Trials Office provides full-service Study Start-Up Services to get your study up and running! Using the CTO allows you and your research staff to focus on study planning rather than on administrative paperwork. Let us handle the stream of emails and phone calls from sponsor representatives inquiring about status updates. Your study start-up is managed by experts, but you are in control. We keep you informed and get your feedback and approval every step of the way.

 

Our Services Include:

Budget development & negotiation – We work directly with OHSU hospital, clinics, pharmacy, nursing, and other units to obtain the most current rates for clinical procedures. Combining these rates with an assessment of your study team's personnel time, we develop a budget that will cover the costs of running the trial, including ensuring that your non-clinical costs are covered. Our extensive experience with clinical trials budgets gives us the knowledge of what sponsors will pay, thereby maximizing your budget.

The median CTO budget is 19% higher than non-CTO budgets (excludes cancer trials)

IRB Submission - We handle the entire IRB approval process, from start to finish. Working closely with you and the study sponsor, we ensure a quick, complete, and accurate submission to the IRB, resulting in rapid approval so that you can start enrolling subjects.

Our median IRB Approval time is 22% faster than non-CTO studies (excludes cancer trials) 

 

IRB submission services include:

  • Creation of the IRB application – the CTO handles all aspects of the electronic IRB application including all the documents needed to support the application
  • Consent form development – adhering to both sponsor and OHSU IRB requirements, we write the consent form(s) and work with the sponsor to obtain their approval of the form(s) prior to IRB submission
  • Subject recruitment materials – need flyers or advertisements to recruit subjects? We create those for you and include them in the IRB submission.
  • Response to IRB review memo – we create the response to the IRB review by working with you and the sponsor to answer questions and revise documents as required by the IRB. The entire response package is completed quickly, allowing you to resubmit the study to IRB to gain final approval.
  • Knight Cancer Institute, Radiation Safety, and OCTRI Submissions – if applicable to your study, we manage these submissions concurrently with the IRB submission to ensure efficient review and approval from all necessary committees.
  • OHSU internal documents & approvals - Let us develop the PPQ, secure Research Rate approvals from applicable departments, and work with PBS on Industrial Account setup.

What are the costs?

There is no cost to you to use the CTO. Our standard fee of $4,000 plus overhead is written into the study budget that we negotiate with the sponsor. We ensure that the sponsor will pay this fee before we start any work. The fee is used solely to support CTO costs, resulting in a revenue neutral model.

How do I start working with CTO?

Getting started is easy! Call the CTO at x 4-5077, or download the CTO Form, complete the requested information, and send to the CTO along with your study materials. We'll get started right away.

Who can I call with questions?

For more information, please contact:

Bridget Adams, MSHS, CCRA 
Manager, Clinical Trials Office
3181 SW Sam Jackson Park Road
MailCode CR107
Portland OR 97239
Tel: x4-5077
Fax: x4-0165

Rebecca Young, MA, CCRP
Senior Research Associate
OHSU Clinical Trials Office
3181 SW Sam Jackson Park Road
CR107
Portland OR 97239
Tel: x4-8102
Fax: x4-0165