Clinical Research Support

New Applications

New Applications to Fred Hutch IRB (Clinical Research Studies)

New Study Application

(Choose one application)


Application for Review - Interventional Research

Use for research involving a research intervention with the intent to change the participant. Research involving a clinical intervention, behavioral interventions, dietary interventions, or any other interaction with a living participant with the intent to change their biomedical condition or behavior should use this form. See "IRB Supplements" for additional application documents

Application for Review - Observational Research

Use for research involving interactions with a living participant for the purpose of collecting data or specimens from the participant with no intent to change them. Biospecimen collection, survey research, long term follow-up, observational research, and other data/specimen gathering involving an interaction with a living participant should use this form. Note, if the collection of data or specimens also involves an intervention, use the Interventional Research version of the IRB application. See "IRB Supplements" for additional application documents

Application for Review - Specimen and Data (No Participant Contact) Research

Use for research projects involving human specimens or data where the scope of the research project does not involve interacting with a living participant. Ancilary studies involving specimens or data collected under another research protocol, repositories and coordinating centers with no participant interactions, research involving non-commercially available de-identified specimens/data/cell lines derived from a human, and any other activity involving human specimens or data where there is no interaction with the human. Note, if the collection of data or specimens also involves interaction with a human, use the Observation or Interventional version of the IRB application. See "IRB Supplements" for additional application documents
 

Cancer Consortium Submission Form


Cancer Consortium Submission Form (updated 05/11/15)
Collects basic information that identifies funding, type of reviews required and information for Core Grant reporting. Completed forms should be submitted to Clinical Research Support.
 

Research Group Review Form

(SRC-applicable studies only)


Research Group Review Information Summary for SRC Form (updated 8/5/15)
To be included for submission to SRC

**Previous versions accepted only if signed before 9/1/15**

UW/CC-IRB Coversheet and Review Authorization

(UW Consortium CC-IRB submissions only)

External Performance Site Feasibiilty Checklist

(CC-led IND studies with external sites only)


External Performance Site Feasibility Checklist
(Cancer Consortium submissions that require EPSAC review)

IRB Supplements


IRB Supplements

Links to IRB supplemental forms
 

Industry Sponsorship Form

(for CC-IRB studies only)


Industry Sponsorship Form

Fred Hutch industry-sponsored studies only. Gives basic Industry Sponsor information prior to the draft contract.
 


 

New Applications to WIRB (Clinical Research Studies)

Cancer Consortium Submission Form


Cancer Consortium Submission Form (updated 05/11/15)
Collects basic information that identifies funding, type of reviews required and information for Core Grant reporting. Completed forms should be submitted to Clinical Research Support.
 

Research Group Review Form

(SRC-applicable studies only)


Research Group Review Information Summary for SRC Form (updated 8/5/15)
To be included for submission to SRC

**Previous versions accepted only if signed before 9/1/15**
 

UW/WIRB Coversheet


UW/WIRB Coversheet

UW Consortium WIRB submissions only
 


 

Expanded Access

Expanded Access


Expanded Access Individual Patient Intake Form

Model Consent Form --  Expanded Access Template
Note: This template contains pre-filled fields to be used only with Expanded Access studies.

New Application (Intervention) -- Expanded Access Template
Note: This template contains pre-filled fields to be used only with Expanded Access studies.


 

Other Reviews That May Apply

Clinical Research Budget & Billing (CRBB)

Institutional Biosafety Committee (IBC)

Office of Sponsored Research


Department link: Office of Sponsored Research


Attachment A
Application Routing and Review Form

Attachment A Instructions
How to complete the Attachment A

Research Implementation Office (RIO)


Department link: Research Implementation Office (RIO)


Clinical Trial Activity Summary (CTAS)

A Clinical Trial Activity Summary (a.k.a. Activity Summary) is required for all therapeutic and diagnostic studies submitted to the Research Implementation Office (RIO) for research pricing and/or implementation review for services occurring at SCCA as of Sept. 1, 2012. The primary purpose of the Activity Summary is for facilitating the financial clearance process for clinical trials.

Clinical Trial Planning and Implementation (CTPI) form
The purpose of this form is to facilitate the implementation of clinical trials that will utilize the SCCA as a performance site by providing pricing for clinical services which will be charged and invoiced to the study budget via an RRR account. This form must be completed to receive pricing for study feasibility analysis and budget planning or to initiate scheduling an implementation review.

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