Standard Operating Procedures (SOP) Templates

Two sets of Standard Operating Procedures (SOP) templates are available for purchase and are described below. Please also note item #3, below, that describes the downloadable "Regulatory References," available at no cost to purchasers of either set of SOPs

1. Standard Operating Procedures for Good Clinical Practice at the Investigative Site
   Licensed by the UW School of Medicine (SOM) from the Center for Clinical Research Practice, these templates are available to SOM faculty by following the instructions posted at http://www.crc.washington.edu/Resources/GCPSOPInvSites.aspx These templates are designed to be customized by study teams to reflect the standards for the day-to-day conduct of their clinical trials. The SOP templates are based on Good Clinical Practice Guidelines and the Code of Federal Regulations. Included are forms, checklists, and 21 SOP templates, including templates for:
   • Responsibilities of the Research Team
   • Assessing Protocol Feasibility
   • Investigator and Site Initiation Meetings
   • Site-Sponsor/COR Communications
   • Sponsor/CRO Monitoring Visits
   • Investigational Drug Accountability
   • Adverse Event Reporting
   • Specimen Collection and Handline
   • Data Management
   • Audits
2. Standard Operating Procedures for Good Clinical Practice by Sponsors
   Licensed by the UW School of Medicine from the Center for Clinical Research Practice, these templates are available to SOM faculty by following the instructions posted at http://www.crc.washington.edu/Resources/GCPSOPSponsors.aspx These SOP templates are designed for investigators who hold their own INDs or IDEs. Investigators who hold INDs/IDEs are expected by the FDA to meet the same regulatory requirements and documentary responsibilities required of sponsors. This is true both of single-site and multi-site studies and is true whether or not the study is intended to result in any new commercial use for the investigational agent. Included with the Sponsor SOP templates are forms, checklists, and SOPs for tasks falling into such categories as:
3. • General Administration
   • Regulatory Affairs (such as reporting requirements and preparation of reports)
   • Protocol Development
   • Study Start-Up (such as investigator selection and site training)
   • Project Management (such as product inventory, records, monitoring visits)
   • Subject Management (such as adverse event identification and reporting)
   • Data Management
   • Quality Assurance

   SOM faculty and staff may want to review hard copies of the templates before deciding whether to purchase them. To review the hard copies, call Gigi Streidl at 206-616-8289.

4. Important Note: Downloadable "Regulatory References," assembled by the Center for Clinical Research Practice, are available at no cost to those who have purchased the SOP templates. Purchasers of the SOP templates may download the Regulatory References by following the instructions posted at http://www.crc.washington.edu/Resources/GoodClinicalPractice.aspx Hard copies of the Regulatory References may also be reviewed by calling Gigi Streidl at 616-8289. Included in the Regulatory References are:
5. • The Nuremberg Code
   • The Declaration of Helsinki
   • The Belmont Report
   • Federal Regulations (21 CFR 11, 50, 54, 56, 312, 812 and 45 CFR 46)
   • Good Clinical Practice Consolidated Guideline (ICH E6)
   • FDA Guidance Sheets
   • FDA Compliance Programs
   • DHHS Policies and Guidance