Aims of the Associate PI Scheme

  • To integrate clinical research into clinical training
  • To develop doctors, nurses, allied health professionals and healthcare professionals to be PIs of the future
  • To recognise and promote doctors, nurses, allied health professionals, and healthcare professionals to engage in NIHR portfolio research in a consistent manner
  • To increase opportunities for patients to be involved in high quality research to improve care

Structure of the Associate PI Scheme

  • Open to Study and Associate PI applications from most NIHR specialties
  • Open to any doctor, nurse, or health professional willing to make a significant contribution to the conduct and delivery at a local level
  • Participation in the Associate PI Scheme does not absolve local PIs of their legal responsibilities at site
  • Commitment of at least 6 months will be required for gaining Associate PI status
  • There is no funding associated with the Associate PI Scheme. Applicants will take part in the Scheme alongside performing their core role
  • Must register prospectively - retrospective recognition is not possible

Associate PI Scheme - Study Eligibility Criteria

  • The study must be on the NIHR portfolio
  • The study must have at least 6 months of recruitment activity left
  • The study must be multi-centred
  • Can be Interventional or Observational - Observational Studies will require further clarification
  • The Scheme is currently not open to fully funded Commercial studies
  • Studies that are In-Setup can join the Scheme, but must be no more than 3-4 months away from recruiting

Studies at the MRC CTU which are taking part in the API Scheme

REFINE Phase II multi-arm basket protocol testing reduced intensity immunotherapy across different cancers
RAMPART Phase III MAMS platform trial of adjuvant therapy in resected intermediate/high risk renal cell cancer
Add-Aspirin Phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours
STAMPEDE Phase III MAMS RCT evaluating Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Associate PI Scheme - Applicant Eligibility Criteria

  • Study registered on the Associate PI Scheme
  • Applicants can only be an Associate PI for one study at a time
  • One Associate PI, per study, per site
  • Any NHS healthcare professional who wants to gain experience of delivering an NIHR portfolio trial
  • Not eligible if your role is specifically funded to work on research
  • Associate PIs must be able to commit to 6 months of working on a study at their site
  • Associate PIs must gain prior approval from their Local PI

Associate PI Scheme - The Process for an Associate PI

  • Check the List of Registered Studies
  • Speak to the Local PI of the study to get their endorsement to join the scheme
  • Complete the registration form
  • The Associate PI works alongside their Local PI for 6 months of the study at the site, the Local PI acts as a mentor during their time on the Scheme
  • Complete the Checklist and complete the Associate PI Scheme Learning Pathway in NIHR Learn
  • Checklist signed off by Local PI and National Study Coordinator.
  • Associate PI Scheme team issues a Certificate, officially confirming Associate PI status
  • Acknowledged in publication from the study in a PubMed searchable way, normally in the appendix as a collaborator.
    Please note we cannot mandate this, but we heavily encourage it.

Associate PI Scheme - Checklist Activities

  • Signature on study-specific delegation log
  • Dissemination to the department
  • Engagement with staff, research team meetings (Diary of research team meetings)
  • Site log, protocol amends, data returns and quality
  • Train staff (GCP, protocol)
  • Screening logs, recruitment/consent of patients or facilitating consent of patients
  • Deputising for PI
  • PPI activities

Benefits of the Associate PI Scheme

For the API

  • Experience of research with the oversight of the local enthusiastic PI
  • Learns about the challenges and practicalities of delivering a portfolio study
  • Participation is recognised through certification for their training portfolio
  • Associate PIs will be acknowledged in the primary publication(s) from the study

For the PI

  • Additional support with the delivery of the study
  • Developing the PIs of the future

For Study Team/CTU

  • Increased support for the trial at sites - managing delegation logs, etc.
  • Speedier delivery
  • Enhanced Recruitment

For the Patient

  • Increased opportunities to be involved in high-quality research

Clinical Trial Webinar Series for APIs

The MRC CTU at UCL will be running a monthly webinar series on the last Tuesday of every month (6-7pm via TEAMS) for all APIs affiliated with a trial at the MRC CTU at UCL.

There will be a range of expert speakers including statisticians, health economists, and experienced investigators.

The timetable for the next webinar series is below:

Tuesday 31st January

Understanding statistics: Hazard ratios, sample size, power calculations

Matthew Nankivell

Senior Statistician MRC CTU at UCL

Tuesday 28th February

How to be a good Principal Investigator

Duncan Gilbert

Clinical Lecturer MRC CTU at UCL and Consultant Clinical Oncology at Brighton and Sussex University Hospital

Previous webinar recordings are available in the links below:

How to get involved

Go to the NIHR Associate PI Scheme Website: www.NIHR.ac.uk/AssociatePIScheme.

To register a study, complete the Associate PI Scheme Study Registration Form.

To register to be an Associate PI, complete the Associate PI Scheme Applicant Registration Form.