Clinical Research Support

Reference Documents

Clinical FYI

CTRP and ClinicalTrials.gov

Data Safety Monitoring

PATS Process

Research Group Review

Seattle Cancer Care Alliance (SCCA)

Seattle Children's

Study Start Up

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.

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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