Who's eligible to use the GKPP?

PIs must meet all of the following criteria: 

• Using at least one of following CCTS services:
  • Clinical Research Unit (CRU) – Nursing, Coordinators
  • Biomarker Analysis Lab (BAL)
• Study must be using OnCore
• Study must be using UK IRB (Central IRBs are not eligible)

How do I add GKPP to my research study?

1. Submit a CCTS Service Request Form and select Global Key Personnel Protocol
2. Review and sign the PI Responsibility Attestation Statement
3. Review the GKPP Research Description and SOP
4. Update your research description to include a description of the GKPP using the template language provided
5. Provide a copy of the IRB approval and research description with the GKPP reference to the CCTS
6. Create and maintain a current Delegation of Authority (DOA) log
7. Maintain the following documentation in your study regulatory binder:
   • GKPP Research Description and SOP
   • CVs for all key personnel
   • Training certificates for: HSP/RCR (online and in person)/GCP (if applicable), DOT/IATA (if applicable) for all key personnel
   • Protocol specific training documentation for all key personnel
   • Licensure (if applicable) for all key personnel
8. Allow CCTS Quality Assurance review of your protocol
9. Provide metrics regarding your study upon CCTS request

The GKPP Flow Map, available below under in the "Toolkit" section, outlines the process and responsibilities of all involved parties. 
 

What are the the benefits of GKPP?

• Improved regulatory compliance
• Ensure CCTS key personnel are always up-to-date on research studies using our services
• Reduce the number of IRB modifications for CCTS key personnel changes
• Reduce the number of protocol violations due to CCTS key personnel not being current on the IRB key personnel list