Global Key Personnel Protocol

Our Goal? Happier PIs and Increased Compliance


We know it's a hassle for investigators to submit IRB modifications whenever there's a CCTS personnel change. That's why we've created the CCTS Global Key Personnel Protocol (GKPP). 

When we have a personnel change, we'll update our GKPP--which means you won't have to submit an IRB modification if our protocol is already included in your study, and your protocol will always have the  current CCTS key personnel.

Request GKPP service here. »

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Who's eligible to use the GKPP?

All CCTS Principal Investigators (PIs) utilizing the UK IRB and whose studies are in Oncore will be eligible to utilize the CCTS Global Key Personnel Protocol with a few exceptions.

PIs utilizing central IRBs are not eligible for the CCTS Global Key Personnel Protocol. PIs only utilizing CCTS regulatory services cannot utilize the CCTS Global Key Personnel protocol as the regulatory personnel must be listed on individual protocols in order to have access to eIRB. For studies utilizing services in addition to CCTS regulatory, the primary and back-up regulatory specialists assigned to the protocol will be added to the PI study protocol as key personnel in order to manage the protocol in eIRB.

 

How do I add GKPP to my research study?

Please submit a CCTS service request form and select "Global Key Personnel Protocol" in the service menu. 

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

 

What are PI responsibilities when using GKPP?
 

  • Review CCTS Global Key Personnel Protocol and SOP
  • Review and sign PI Responsibility Attestation Statement
  • Reference CCTS Global Key Personnel Protocol in Research Description
  • Maintain a current Delegation of Authority Log
  • Provide a copy of the IRB approval and research description with the CCTS Global Key Personnel Protocol referenced
  • Provide protocol specific training to key personnel, as necessary

  • Maintain the following in the regulatory binder:

    • CCTS Global Key Personnel Protocol and SOP

    • CVs for all key personnel

    • Training documentation

    • HSP

    • GCP

    • RCR (online and in-person)

    • DOT/IATA (when applicable)

    • Licensure (when applicable)

  • Allow Quality Assurance review of all protocols using CCTS Global Key Personnel Protocol
  • Provide metrics when requested

Note: The PI may delegate these tasks as they choose.


 

What are then the benefits of GKPP?

  • Ensure CCTS key personnel are always up-to-date on IRB required credentials

  • Ensure CCTS key personnel working on specific studies are current at all times

  • Reduced number of modifications for CCTS key personnel changes for CCTS Regulatory

  • Reduced number of modifications for PIs managing their own Regulatory

  • Reduced number of IRB submissions

  • Reduced number of protocol deviations reported to the IRB due to key personnel working on studies when they have not been added to IRB

  • Increased compliance

     

GKPP Toolkit


 

Questions? Contact:

  • Laura Ashe, CCRC

    • Manager, Regulatory Knowledge & Support Core
    • llashe2@email.uky.edu
    • (859) 323-2782
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GKPP Principal Investigator

  • William Stoops, PhD

    • Director, Regulatory Knowledge and Support Core
    • william.stoops@uky.edu
    • (859) 257-5388
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