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Associate PI Scheme

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Over to you - Group discussion

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Potential Points for Discussion

Promoting the champion role within a trust

Training structure and duration for Champions

Methods to maintain engagement with APIs

Unresponsive Associate PIs

Appropriate evidence for the Checklist

Improving Associate PI uptake

Learning from industry

Unengaged TMs/trials

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Role of the National Study team in signing off the Associate PI Checklist

  • Not expected to review and confirm all Checklist activities.
  • Comments on those activities the CTU/Sponsor has direct involvement in.
  • Associate PI Scheme Contact asked to confirm, to the best of their knowledge, that activities described were undertaken by Associate PI.
  • Checklist review will require TM to look for record of completion of activities – should not be done from memory.
  • If TM agrees that sufficient evidence has been supplied:
    • Communicated to Central team via signature of the Checklist
    • And once Local PI confirms agreement –
      • NIHR awards Associate PI status to the candidate

Please note: The term 'National Study Team' refers to the Clinical Trials Unit (CTU), Sponsor, Research & Development (R&D), or any managing organisation acting on behalf of the Sponsor.

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Associate PI Checklist Activities for National Study team Input

  • Signature on study-specific delegation log
  • Dissemination to the department.
  • Engagement with staff, research team meetings
  • Updated delegation logs
  • CRF completion, resolution of CRF queries
  • Train staff (GCP, protocol)
  • Screening logs completion
  • Consent and recruitment
  • Deputising for PI
  • PPI activities
  • Engagement with CTU
  • Engagement with TMG

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Please note: The term 'National Study Team' refers to the Clinical Trials Unit (CTU), Sponsor, Research & Development (R&D), or any managing organisation acting on behalf of the Sponsor.

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National Study team and the Associate PI Checklist

  • National Study team sign off on checklist:
    • Helps ensure standardisation of scheme
    • Acts as an important “Quality control”
    • Helps Associate PI understand the key role of CTUs in NIHR portfolio studies

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Please note: The term 'National Study Team' refers to the Clinical Trials Unit (CTU), Sponsor, Research & Development (R&D), or any managing organisation acting on behalf of the Sponsor.

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Next Steps

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Thank you

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NIHR.ac.uk/AssociatePIscheme

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Email: associatepischeme@nihr.ac.uk

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