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
- 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)
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