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

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

Please see the timetable for the upcoming webinar series below:

Thursday 31st March Trial design including novel trial designs and non-inferiority trials Matthew Nankivell
Senior Statistician MRC CTU (UCL)
Thursday 28th April Pharmacovigilance and Safety Hannah Rush
Clinical Fellow MRC CTU (UCL)
Thursday 26th May An Introduction to Health Economics Caroline Clarke
Health Economist (UCL)
Thursday 30th June Understanding statistics: Hazard ratios, sample size, power calculations Matthew Nankivell
Senior Statistician MRC CTU (UCL)
Thursday 28th July How to be a good Principal Investigator Duncan Gilbert
Clinical Lecturer MRC CTU (UCL)

These sessions will be recorded and will be available here.

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.