Clinical Research Support

Study Start Up

Because of the complexity of new study submissions, and the various review processes determining they may undergo, Protocol Review Coordinators (PRCs) are trained to assist study teams in identifying the appropriate review process, identifying the necessary forms, and planning a timeline for review.

Protocol Review Coordinators can provide an email tailored to the type of study being submitted. This email includes links to forms and specific information needed to begin the process.

Below you will find documents describing the process for new submissions based on the type of study (intervention or non-intervention) and the origin of the study (FHCRC Clinical Research Division, UW Cancer Consortium, etc.).

Additionally, you will find more information for each step in the process on the following pages:

 

Study Submission Procedure Overview

Click on the study type below to read a summary of submission procedures:

Interventional Research

Use for research involving a research intervention with the intent to change the biomedical condition or behavior of a living participant.

 

  • Interventional Research Guidelines
    For FHCRC/UW Cancer Consortium as well as NCI-Designated National Cooperative Group, PHS, and VIDD studies being submitted to the Cancer Consortium IRB

 

Observational Research

Use for research involving interactions with a living participant for the purpose of collecting data or specimens with no intent to change the participant.

 

  • Observational Research Guidelines
    For FHCRC/UW Cancer Consortium as well as NCI-Designated Cooperative Group studies being submitted to the Cancer Consortium IRB 

 

Specimens or Data Research

Use for research involving human specimens or data and does not involve interacting with a live participant.

 

 

Interventional Research / Expanded Access INDs

Use for a protocol regulated by the Food and Drug Administration that allows physicians to provide treatment with an investigational new drug to a patient with a serious disease or condition who cannot participate in a clinical trial.
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