Clinical Research Operations

Preparation for Scientific Review - Checklist Only

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

• Typographical errors
• Editorial corrections
• Correct formatting (CTEP format, NCI IRB format)
• Eighth grade readability
• FDA required items (See 21CFR 50.25 Elements of Informed Consent)