NIHR Associate Principal Investigator (PI) Scheme | MRC Clinical Trials Unit at UCL

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 Thursday of every month (1-2pm via TEAMS) for all APIs affiliated with a trial at the MRC CTU at UCL. Please note the session in July will be on the 13th.

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

The timetable for the next webinar series is below:

Date	Topic	Speaker
30^th March 2023	How to report serious adverse events	Hannah Rush Medical Oncology Registrar and Clinical Research Fellow at MRC CTU at UCL
20^th April 2023	How to design a trial including novel trial designs and non-inferiority trials	Matt Nankivell Senior Statistician at MRC CTU at UCL
25^th May 2023	Understanding statistics: sample size calculations	Matt Nankivell Senior Statistician at MRC CTU at UCL
29^th June 2023	Patient and Public Involvement in Clinical Trials – what and why?	Ben Cromarty Patient representative Kate Sturgeon Senior Research nurse and Patient and Public Involvement Coordinator at MRC CTU at UCL
13^th July 2023	How to be a good Principal Investigator	Duncan Gilbert Consultation Clinical Oncologist and Senior Lecturer in Cancer and Clinical Trials at MRC CTU at UCL

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.