Study Coordinator Tools - Standard Operating Procedures (SOP)

The following Standard Operating Procedures can only be viewed while inside the OHSU network. Please note: These are only examples and are drafts in some cases. They should be used to guide the development of unit specific SOPs.

OHSU Cancer Institute (OCI)

• Adverse Event Reporting
• Consent Form
• Consent Form - Non-English Speaking
• Continuing Review Questionnaire
• Clinic Billing
• Doctor Order Template
• FDA Form 1572
• Industrial Account Numbers & Research Rates
• Investigational Pharmacy New Study
• Medicare Coverage of Routine Costs Checklist
• Organization & Managment of Source Documentation
• Protocol Card
• Protocol Revision/Amendment Form
• Regulatory Binder Organization
• Study Closure & Termination

Clinical Research Center

• Consenting Research Participants
• CRC Request for Admission
• Protocol Deviations
• Monitoring and Reporting Adverse Events

Doernbecher SOP Manual

Last modified on 06/29/2004 by rdaweb@ohsu.edu