CTRP and ClinicalTrials.gov
Data Safety Monitoring
- Data and Safety Monitoring Plan (DSMP) (revised 09/2014)
Research Group Review
Seattle Cancer Care Alliance (SCCA)
- Clinical Trials Activity Summary (CTAS) (revised 03/12/14)
- Clinical Trial Planning and Implementation (CTPI) Form (revised 06/30/14)
- Medical Records Requests for Research Purposes (revised 07/16/14)
- Patient Safety Net (PSN) - Research Staff Training Ongoing (revised 02/27/12)
- Research Charge Capture - Research Staff Training Ongoing (revised 10/2012)
- SCCA Clinical Trials Policy (CTP) - Research Staff Training Ongoing (revised 01/20/11)
- Child Abuse & Neglect Online Training (added 4/22/14)
- Emergency Pocket Guide Information (added 4/22/14)
- Fire and Life Safety (revised 04/08/14)
- Research Non-Employee Orientation (revised 04/08/14)
- Seattle Children's Access Request and Requirements Checklist (revised 04/08/14)
- Seattle Children's Compliance Guidelines for Non-Employees (added 4/22/14)
- Seattle Children's NEAT Paperwork (revised 09/19/13)
- Study Start-Up Procedure
- FH-SCRI Protocol Implementation and Research Billing
- WA State Mandated Reporter (added 4/22/14)
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
- Interventional Research Guidelines - WIRB for UW Cancer Consortium studies being submitted to the Western Institutional Review Board (WIRB).
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.
- Specimens or Data Research Guidelines for FHCRC/UW Cancer Consortium studies being submitted to the Cancer Consortium IRB.
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.