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Preparation for Scientific Review - Checklist Only

SOP #: RPS-2

Next Review Date: 04/2014

Version #: 1.0

Review Interval Period: Biennial

Approved Version #: 1.0  Date:  04/2012

Policy Reference:  

To provide a checklist to use in the Quality Control process for protocols, protocol appendices, and consents.
Step 1: The Protocol document and any appendices will be reviewed and corrected
  • Typographical errors 
  • Editorial corrections 
  • Correct formatting (CTEP format, NCI IRB format) 
  • General readability 
  • Content (as applicable)
    • Table of Content
    • Face sheet
    • Précis
    • Registration information
    • Phase of study (i.e. Phase 1 dose escalation information with definitions of DLT and MTD)
    • Multi-Institutional guidelines
    • Correct versions of adverse event criteria and response criteria
    • Section for Sample Storage, Tracking and Disposition
    • Statistical Section matches objectives and number of patients
    • Section on Human Subjects Protections
    • NCI IRB AE reporting requirements, expedited and annual, IND Safety Reports
    • IND sponsor, FDA and/or OBA and IBC safety reporting
    • Data and Safety Monitoring Plan
  • Consistency
    • Between sections
    • With the references
    • Referencing sections
    • Referencing tables, figures and appendices
    • Page numbers are match document in table of content
Step 2: The protocol consent will be reviewed and corrected
Last updated by Richman, Michele (NIH/NCI) [C] on Oct 31, 2014