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
- 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
- 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:
-
- 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.
- 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:
-
- 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
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