Associate PI Scheme - FAQs

  • Published: 30 May 2019
  • Version: V6 - September 2024
  • 29 min read

Find answers to frequently asked questions about applying to the Associate Principal Investigator (PI) Scheme.

Who is eligible to be an Associate Principal Investigator trainee?

The scheme is open to any health and care professional who does not have research as a core part of their role, but wishes to gain skills and experience by contributing towards an NIHR Portfolio adopted study. This includes, but is not limited to, doctors, nurses, pharmacists, physiotherapists, and so on. We encourage all health and care professionals to consider taking part.

Please note, though we allow all health and care professionals who aren’t already involved in research to take part, the Associate PI Scheme is guided by the studies and safety requirements within the protocol. The Local Principal Investigator would need to agree that the study would enable you to meet the mandated Associate PI checklist criteria and that your delegated duties are in line with the safety requirements of the protocol.

What is the eligibility criteria I must meet to apply to be an Associate PI trainee?

Interested applications must:

  • be a healthcare professional who wants to gain knowledge of what it means to deliver an NIHR portfolio study
  • be able to commit to 6 months of working on a study registered onto the scheme at the same local site, once their spot on the Associate PI Scheme is confirmed
  • have spoken to the Local Principal Investigator of their chosen study and gained their mentorship approval prior to applying
  • not currently working in a full time funded research role (e.g research nurse)

If you are a ‘Fellow’ (eg Research Fellow, Clinical Fellow), then you must:

  • Not be receiving funding to work on the study that you want to be an Associate PI for. However, you can be an Associate PI on a study that is outside of your funded fellow role. Enrolment in these cases will be made on an individual basis.

I work in primary care (GP, pharmacy, dentist, optician services, etc) , am I eligible?

Yes, the scheme is open to any health and care professional. The Associate PI Scheme is guided by the studies and safety requirements within the protocol. The Local Principal Investigator would need to agree that your chosen study would enable you to meet the mandated Associate PI checklist criteria and that your delegated duties are in line with the safety requirements of the protocol.

Please refer to the ‘Taking part in the scheme’ section of the FAQs for more details on how the scheme works in a primary care setting.

I am a student, am I eligible?

Students are not eligible to be Associate PIs, because the scheme requires significant input over at least 6 months and this is not compatible with most student placements. Students must qualify before becoming eligible to join. We strongly encourage students to become involved in clinical research in other capacities in a way that fits with their training.

I am a research nurse, am I eligible?

If your role already includes research, you are not eligible for the Associate PI Scheme. This is because the Associate PI Scheme is  aimed at healthcare professionals who don't primarily work in research but want to gain research experience on a NIHR Portfolio research study.

Research nurses can apply for the Principal Investigator Pipeline Programme (PIPP)

Are clinical trial pharmacists eligible for the scheme, even if fully funded by research?

Yes, we recognise that the work that clinical trials pharmacists do puts them in a slightly different category to other fully-funded research staff (such as research nurses), and therefore we will allow applications from clinical trials pharmacists.

I am funded less than 50% of my time to conduct research, am I eligible?

If you are funded 50% or less of your time to conduct research, then you could be eligible to take part in the Associate PI Scheme. Please email associatepischeme@nihr.ac.uk and we can discuss eligibility with you. Enrolment in these cases will be made on an individual basis.

How do I apply to become an Associate PI Trainee?

  1. Find a study at your local site that is registered on the Associate PI Scheme. You can use our Open Data Platform Dashboard to do this: Where can I take part?
  2. Once you have identified a study at your site, get approval from the Local Principal Investigator of the study before you proceed any further
  3. Apply to join the scheme by completing the Associate PI Scheme application form: Apply to become and Associate PI trainee
  4. We will check your application against our eligibility criteria and will email your local PI for approval
  5. Once we have the approval from your local PI, you will receive an email confirming your place on the scheme. This is when you can begin your 6 month tenure.

Once you complete your 6 month tenure and get your certificate, you qualify as an Associate PI.  While you are on the scheme, you will be referred to as an Associate PI trainee.

Where can I check which studies are registered onto the scheme?

Use our Open Data Platform Dashboard to find registered studies: Where can I take part?

Follow the instructions at the top to filter for your choice of trust and site. If you have any further questions please contact the Associate PI Scheme Team at associatepischeme@nihr.ac.uk

Full list of studies

You can also view a Full List of Registered Studies. Please be aware this list is very long so we advise using the ‘Where Can I Take Part?’ tool instead.

Is there an interview as part of the Associate PI application process?

No, though we do expect you to have a conversation with the local PI of the study you're interested in contributing towards, prior to submitting your application form.

Do I have to prospectively register for the Associate PI Scheme?

Yes, we do not accept retrospective applications.

You must apply, go through our eligibility checks, and then be officially registered onto the Associate PI Scheme before you assume the role of Associate PI Trainee.

The start date of your 6 month tenure is the date you receive the email from the Associate PI Scheme Team confirming your place on the Associate PI Scheme. You must then complete 6 months on the scheme after this date.

We will not issue certificates to those that have applied after they have completed 6 months of working on a study. This would be considered a retrospective application and will be rejected.

When is the best time to apply for the Associate PI Scheme?

Ideally, we recommend that you apply when the study you wish to contribute towards is actively recruiting at your site. Your local PI can advise you on the current stage of the study.

We do also allow involvement during the earlier study set-up stage. However, your site must have submitted the local capacity and capability form to the R&D department to ensure that participant recruitment is imminent. If you’re unsure what this means please ask the Principal Investigator of the study at your site.

I want to register to be an Associate PI trainee but the study that I want to be part of is not registered onto the Associate PI Scheme

If the study that you wish to be involved in locally is not listed on the Associate PI study list, that means the national study team for that study has not applied for the study to be included in the scheme. You may wish to contact the national study team and encourage them to register their study onto the Associate PI Scheme.

Can I apply to be an Associate PI for more than one study at a time?

No, you can only register for one study at a time, at one site.

However, after completing the 6 month tenure for one study, you can apply for a new study if you wish to continue participating in the Associate PI Scheme.

I’m interested in a study which lies under a department/speciality which is different from my own, can I still apply to be an Associate PI on that study?

Yes. You may still apply to be an Associate PI for a study even if it falls under a different department or specialty than your own.

The decision depends on whether your involvement in the study would allow you to fulfil the required Associate PI checklist criteria. To proceed, you must obtain approval from the local PI before submitting your application form.

What are the benefits of taking part in the Associate PI Scheme?

There are multiple benefits to taking part in the Associate PI Scheme. These include gaining:

  • hands-on experience of research delivery
  • mentorship from an experienced PI
  • a foundation of research delivery knowledge to support you in your research career
  • evidence for your training portfolio, via the checklist 

You also get recognition through certification for your training portfolio and may be acknowledged in the primary publication(s) from the study.

How long does the scheme take to complete?

Associate PI Trainees are required to engage in a study at a singular site continuously for 6 consecutive months.

This involvement may occur partially during the set-up phase and during patient follow-up, but it must encompass participant recruitment as well.

Alumni of the scheme indicate they spend roughly 2-3 hours per week dedicated to their Associate PI Scheme activity over the 6 month period, however we do not mandate this.

How many hours per week am I expected to complete ?

There is no specific requirement for the number of hours per week you must dedicate to the Associate PI Trainee role. You can integrate it into your existing responsibilities as necessary.

Feedback from Associate PI Alumni suggests that typically they commit around 2-3 hours per week, although this may vary depending on the study.

It's advisable to discuss the expected time commitment for your specific situation this with your local PI before applying.

How do you complete the Associate PI Scheme?

To officially receive a certificate and be granted ‘Associate PI’ status, you must fulfil all required components outlined in the Associate PI Scheme checklist within the 6 month period of your tenure.

We will provide you with the checklist template once you have successfully registered. It contains activities such as participant recruitment and reviewing screening logs.

Is there any funding available to support my time on the scheme?

No. An Associate PI Trainee takes part in the scheme alongside performing their core role.

Do I need to complete GCP training?

Yes, it is mandatory that each Associate PI trainee who registers for the scheme must complete GCP training.

If you have already completed GCP training prior to the scheme then you do not need to complete it again, unless you are due to do the GCP refresher training.

I work in a primary care setting as part of a cluster/group of practices. How do I complete the scheme?

If you work within a primary care setting as part of a cluster or group of practices, the checklist activities and completion process remain the same.

Your local PI, who will mentor you through the scheme, should be located at the same site as you.

However, if you work within a cluster or grouping of GPs and the local study PI is based at a different practice, please contact associatepischeme@nihr.ac.uk to explore your options further.

I’ve finished my 6 month tenure and received my certificate. Can I still support the study I was an Associate PI trainee on?

Yes, once you have received your certificate you are officially declared as the ‘Associate PI’, which means you have finished your 6-month tenure and are free to act in whatever capacity you want, with agreement from the National Study Team and the local PI of course.

An Associate PI Trainee is someone who is currently on their 6 month tenure, but has not yet completed the scheme.

An Associate PI is someone who has finished their 6 month tenure, submitted a completed checklist, and successfully received a certificate granting them ‘Associate PI’ status.

Must I be working in an NHS trust with a registered trial to be part of this scheme? What if there are no trials registered on the Associate PI Scheme in your NHS Trust?

To participate in the Associate PI Scheme, you need to be employed at the same site where the study is being conducted. If there are no trials registered on the Associate PI Scheme within your NHS Trust, you can still encourage the National Study Team of any relevant studies at your site to join the scheme. This can be done by reaching out to them and introducing them to the benefits of the Associate PI Scheme.

Can I take part in the Associate PI Scheme remotely?

No, participation in the Associate PI Scheme requires you to work at the site where the study is being conducted. This ensures that you receive in-person mentorship from the local PI and gain hands-on experience in delivering a study at the site.

Can I transfer/rotate from one site to another and continue as an Associate PI trainee?

Yes, it is possible to participate in the Associate PI Scheme at a new site, provided that the same study you are currently involved in is also recruiting participants at your new location.

If you are transferring to another site, you need to get approval from the local PI at your new site to ensure they are willing to mentor you for the remainder of your tenure.

If there is already an Associate PI Trainee at the new site working on the same study, you must ensure that the local PI is comfortable supporting both of you during your rotation.

Please send us details of your new site and the new local PI who will be mentoring you. Email associatepischeme@nihr.ac.uk

We will then coordinate with both your original local PI and the new PI at your new site to gain approval. It's recommended that you have your original local PI sign off on your checklist before leaving your old site, and then have your new local PI sign off when you complete your tenure at the new site.

What happens if the study I am contributing towards is paused/suspended during my 6 month tenure?

We would hope that the study team will already have contacted us to let us know that their study is paused/suspended, and we would contact you to inform you of this.

However, if the study you are working on the scheme for is paused/suspended and we have not contacted you, then please email the Associate PI Scheme Team to let us know by emailing associatepischeme@nihr.ac.uk. We will then contact the study team to clarify the situation.

Once we know a study is paused/suspended, we will contact you to discuss your individual situation and advise on next steps.

What should I do if I can no longer continue my tenure on the Associate PI Scheme?

If you find yourself unable to continue with the Associate PI Scheme, the first step is to discuss your situation with your local PI. They may be able to provide support or accommodations to help you continue in the scheme.

If, after speaking with your local PI, it becomes evident that continuing in the Associate PI Scheme is not feasible, you should inform the National Study Team of your decision.

Once both your local PI and the National Study Team are informed of your decision, please email us at associatepischeme@nihr.ac.uk. If you're comfortable doing so, please share your reasons. We will use any feedback for improving the scheme in the future.

Where can I find further guidance on completing the Associate PI Scheme?

Further guidance can be found in our Associate PI Toolkit.

How do I get access to the Associate PI Scheme Learning Pathway on NIHR Learn?

Once your application for the Associate PI Scheme has been accepted and confirmed, you will receive an email containing a link and an enrolment key. This information will grant you access to the NIHR Associate PI Scheme Learning Pathway on NIHR Learn.

I’ve previously completed the Associate PI Scheme, can I take part again?

Yes, upon completion of the scheme you are eligible to apply again, as long as it is for a different study.

How do I access the Associate PI Scheme checklist?

When you have successfully enrolled onto the scheme you receive an email containing a link and enrolment key, which grants you access to the NIHR Associate PI Scheme Learning Pathway (which contains the online checklist).

At the end of your tenure you export the online checklist to a pdf file. Here's an example of a well-completed checklist from a past alumnus.

I have accessed the Associate PI Scheme checklist via NIHR Learn what should I do next? Do I need to fill in every box on the Associate PI checklist?

To begin your learning pathway, click on the Month 1 tile. In Month 1 you will see suggestions of mandatory checklist activities to begin engaging in. You should evidence the activities you have undertaken each month on your online checklist.

When completing the checklist you should outline your learning by writing a journal-style entry in the appropriate fields. You may notice some items have an exclamation point next to them - these items are mandatory and must be completed before you can export your checklist at the end of your 6-month tenure.

How much evidence do I need to provide for each checklist activity?

For each checklist activity, we expect you to provide detailed evidence of how you completed that activity, who supported you, what you did to complete the activity, what you learnt through doing the activity. 1-2 paragraphs per activity will be sufficient.

As an Associate PI Trainee, can I add people to the delegation log and sign them off to recruit people?

As an Associate PI Trainee, you can add individuals to the delegation log, but it's the responsibility of the PI to formally sign off on both the individuals and the delegated activities.

Who needs to provide a signature on my completed checklist at the end of my 6-month tenure?

All the fields should be outlined clearly on the final page(s) of your exported checklist.

The local Principal Investigator of the study at your site (your mentor) and the National Study Team Representative (this is normally the sponsor representative) will be required to sign off your checklist.

We recommend you make contact with both of these people early as they can offer you support during your time on the scheme.

What do I do with my completed checklist?

Prior to exporting the checklist we recommend you review the evidence you have previously documented, ensuring all mandatory fields have been completed. To export a pdf copy of your checklist, click the ‘Save and Export as PDF’ button at the bottom of the online checklist. If that button is greyed out, that means there is still an incomplete mandatory field on your checklist (it could be an empty text box somewhere, or an unticked checkbox).

Once exported, you should meet with your local PI to review the checklist. If completed satisfactorily, the PI and Associate PI Trainee (yourself) should sign the checklist. The Associate PI Trainee (you) should then send it to the National Study Team, to attain the third and final signature.

Once you have a fully signed copy of your checklist you are now ready to submit it. Navigate back to the Associate PI Scheme learning pathway homepage on NIHR Learn, and select the ‘Upload Associate PI Checklist’ tile.

Click the ‘Add submission’ button and drag-and-drop the fully signed copy of your checklist into the submission box, then click ‘Save changes’.

You have now successfully submitted your checklist. The Associate PI Scheme Team will review your submission within the next 5-7 working days, and you will hopefully receive a confirmation email containing instructions on accessing your certificate.

When and how do I receive my Associate PI certificate?

Once you have uploaded a fully signed copy of your checklist via the ‘Upload Associate PI Checklist’ tile, the Associate PI Scheme Team will review your submission within the next 5-7 working days.

Once the Associate PI Scheme Team have reviewed your fully signed checklist and deemed it to be a successful submission, your certificate will be made available for download via the course homepage ‘Download Associate PI Scheme Certificate’ tile.

Additionally, you will receive an email congratulating you and providing you with instructions on how to access your certificate.

What recognition do I receive for being an Associate PI?

Your certificate will indicate the study, time period, and site at which you attained your Associate PI status.

Study Teams are encouraged to acknowledge all certified Associate PIs in the primary publication(s) from the study. The exact details of this should be included in the study protocol.

Although a publication is a tangible output, of more significance are the enhanced skills and understanding around the delivery of NIHR Portfolio research which you will gain through taking part in this scheme.

We strongly encourage you to add the certificate to your career portfolio.

More information

If you have any further questions please email associatepischeme@nihr.ac.uk

You can also visit main information page:

Associate Principal Investigator (PI) Scheme

Find answers to frequently asked questions about registering studies for the Associate Principal Investigator Scheme.

What is the eligibility criteria my study must meet in order to be registered on the Associate PI scheme?

The study must:

  • be adopted on the NIHR Portfolio
  • received all relevant governance approvals
  • have at least 6 months of recruitment activity left to go still
  • have a Managing Organisation (CTU,  R&D, sponsor,  CRO etc)
  • offer Associate PI Trainees the opportunity to experience and develop skills on:
     
    • the local implementation of studies
    • being personally involved in recruiting participants (this includes having the opportunity to facilitate or shadow informed consenting)
    • reviewing screening and delegation logs
    • interacting with a representative of the sponsor
    • engaging with and developing the local team to deliver a study

What are some examples of a ‘Managing Organisation’?

A managing organisation could be a sponsor, R&D, CTU or CRO.

My study has an observational design, is it eligible for the Associate PI Scheme?

Observational studies are eligible for the Associate PI Scheme, provided that the study offers Associate PI Trainees the opportunity to experience and develop skills on:

  • the local implementation of studies
  • being personally involved in recruiting participants (this includes having the opportunity to facilitate or shadow informed consenting)
  • reviewing screening and delegation logs
  • interacting with the National Study Team
  • engaging with and developing the local team to deliver a study

My study is currently in the set-up phase, is it eligible to be registered on the Associate PI Scheme?

While studies in the set-up phase can join the Associate PI Scheme, it's generally advisable to wait until the study is open for recruitment before applying.

However, if the study is more than two months away from opening for recruitment, it may be placed in a 'Pre-registration' status. This status indicates that the study will be eligible for Associate PI Trainees in the future, but currently does not allow applicants to register onto the study.

This precaution is taken because an Associate PI Trainee's tenure must include participant recruitment, and their term lasts for 6 months. If the study's set-up phase is expected to take longer than 2-3 months, it's preferable to delay allowing Associate PI Trainee applicants to start working on the study until the recruitment stage is closer.

I am a Chief Investigator or member of staff based within a CTU, and I would like my study to take part in the scheme. How do I organise this?

  1. Check if your study meets the study eligibility criteria above.
  2. Complete the Associate PI Scheme Study Registration Form. (Please note, you will need to create an NIHR Learn account if you have not used it before)
  3. We will check your application against our study eligibility criteria, and will then seek approval from 2 parties:
     - the Chief Investigator of the study (unless they are the one that has submitted the application)
     - the Managing Organisation Signatory (this is normally the Director of the clinical trials unit / sponsor, or the equivalent person at the organisation managing the delivery of the study)
  4. Once we have received the approvals, you will receive an email confirming your study is registered on the scheme

Does the Research Ethics Committee (REC) need to be informed that a study is joining the scheme?

No, REC does not need to be informed. The local PIs remain responsible for study oversight at their respective sites, which includes the activities of the Associate PI.

Who should complete the study application form to register the study on the Associate PI scheme?

The study application form should be completed and submitted by a member of the national study team, for example the Trial Manager/Study Coordinator, or Chief Investigator.

My study plans to extend the recruitment end date, but the old date is on CPMS, is it eligible to join the Associate PI Scheme?

Before applying to register onto the Associate PI Scheme, it's crucial that if your study has been granted an extension. The recruitment end date on CPMS (Clinical Portfolio Management System) must be updated to reflect the new end date as approved by the extension. Please contact your Local Clinical Research Network (LCRN) lead for further help here. Find your Local Clinical Research Network

What do I do if I don’t think the study should be part of the Associate PI Scheme?

If you believe that a particular study should not be part of the Associate PI Scheme, you can communicate your concerns during the application process.

Approval from both the Chief Investigator and the Managing Organisation is required for a study to be registered onto the Associate PI Scheme.

If either party expresses reluctance to participate, they have the option to reject the study's inclusion in the scheme. It's advisable for both parties to engage in a discussion to understand each other's reasons before making a decision to reject the study's participation in the scheme. This ensures transparency and enables potential issues to be addressed effectively.

What are the benefits of joining the Associate PI Scheme for my study?

Study teams have fed back to us the following benefits of having Associate PIs work on their studies:

  • increased support for the trial at sites
  • increased Data Quality
  • speedier delivery
  • enhanced Recruitment
  • capacity building
  • supporting a culture of research within your department

Who is responsible for promoting that the study has joined the Associate PI Scheme?

It is the responsibility of the National Study Team to promote that their study has joined the Associate PI Scheme.

We would encourage study teams to let all of their recruiting study sites and Principal Investigators know that the study has joined the Associate PI Scheme, and that the local PIs should be actively looking for eligible colleagues to apply to be an Associate PI Trainee at their site.

Help promoting the scheme

Who within the National Study Team is expected to interact with Associate PI Trainees?

When completing the study application form, in the final section you are asked to provide the details of an ‘Associate PI Study Contact’ who will be responsible for interacting with the Associate PI Trainees.

The nominated ‘Associate PI Study Contact’ will be expected to know who their study’s Associate PI Trainees are and interact with them during their time on the scheme.

Contact should be made between the Associate PI Study Contact and any new Associate PI Trainees that join.

We encourage the Associate PI Study Contact to make contact with their Associate PI trainees to introduce themselves, and explain to them what the role of the National Study Team is in delivering an NIHR portfolio study.

Essentially, we would expect that the nominated Associate PI Study Contact interacts with the Associate PIs during their time on the scheme to ensure they feel supported and are keeping up with the tasks on their checklist.

How can I find out who the Associate PIs are that are working on my study?

We have created a bespoke Associate PI Dashboard for National Study Team representatives, for studies that are registered for the Associate PI Scheme. Sign in and click on 'Restricted study coordinator'.

The dashboard will give you access to the Associate PI data for your study or studies).

Guidance on using the dashboard

If you can't access the dashboard, please email us at associatepischeme@nihr.ac.uk 

Is it possible for there to be two or more Associate PI Trainees undergoing their 6 month tenure at the same site?

Typically, PIs mentor one Associate PI Trainee at a time. However, if the local PI is open to mentoring multiple Associate PI Trainees concurrently, we can accommodate this arrangement.

We base our decision on the capacity of the local PI. Please notify us via email at associatepischeme@nihr.ac.uk if there are plans for two Associate PI applications for one site.

Who, in the National Study Team, should sign off the Associate PI checklist at the end of someone’s 6 month tenure?

The Associate PI Study Contact, typically the sponsor representative, study coordinator, or trial manager, should sign off on an Associate PI Trainee's checklist.

However, technically, any member of the National Study Team can fulfil this role.

Certain tasks on the Associate PI Scheme Checklist require review by the National Study Team Representative to verify that the Associate PI completed them and provided adequate evidence. These tasks involve interactions with the managing organisation of the study or activities for which the managing organisation has direct evidence (eg completed delegation logs).

National Study Team representatives are asked to verify the completion of these checklist activities. Checklists should only be signed off if the Associate PI Trainee has satisfactorily completed and provided evidence for all core activities and has already obtained the signature of the local PI.

Completion of "additional activities" is desirable but not mandatory. More detailed guidance on signing off an Associate PI’s checklist can be found in our National Study Team toolkit.

What is the expectation for acknowledging Associate PIs in publications from the study?

Associate PIs should be acknowledged for their work in all primary outputs from a study. This should be done in a PubMed searchable way so it can be cited on their CVs if possible. In line with the UK policy framework for health and social care research section 9.3.C, Associate PIs should be listed by name and/or by site in the list of collaborators or local investigators at the bottom of the manuscript.

More information

If you have any further questions please email associatepischeme@nihr.ac.uk

You can also visit our main information page:

Associate Principal Investigator (PI) Scheme

Find answers to frequently asked questions about the Associate Principal Investigator Scheme if you're a Principal Investigator (PI).

I have been approached by someone interested in applying for the Associate PI Scheme, what should I do?

We encourage anyone interested in becoming an Associate PI Trainee to speak to their local PI to gain their approval prior to applying to join the scheme. During this conversation, you should assess them against the eligibility criteria and decide whether you feel they are suitable to take part in the scheme.

An applicant will take part in the scheme on top of performing their core role, so it is also important to speak to them about whether they feel they have enough capacity to take part in the scheme as well as performing their core role. Please note, there is no funding associated with the Associate PI Scheme.

If you feel that an applicant is eligible, then you should encourage them to formally apply.

Find out more: Guidance Documents for Local Principal Investigators

What are my responsibilities in regards to approving a prospective Associate PI Trainee for the Associate PI Scheme?

As the local PI, you will receive an email from the Associate PI Scheme Team asking you to approve someone who has applied to join the scheme. When approving, you are agreeing to mentor and support that Associate PI Trainee during their 6 month tenure on the Associate PI Scheme.

Find out more about approving an Associate PI trainee: Guidance Documents for Local Principal Investigators

As a PI, what are my responsibilities to the Associate PI Trainee that I am mentoring?

As the local Principal Investigator, your main role in regards to the Associate PI Scheme is to mentor, support and guide your Associate PI Trainee during their 6 month tenure on the scheme.
For a lot of Associate PI Trainees, this will be their first experience of delivering research so you need to mentor them on what is involved in delivering a study at a site. You need to pass on your knowledge and experience of leading on a study at a site so they understand the practicalities and challenges involved.

You also need to support and empower them to complete their Associate PI Scheme checklist. This is a checklist of activities to help Associate PI Trainees gain understanding and skills relating to study delivery and management. We recommend that you look at this checklist with your Associate PI Trainee and discuss how they can complete all the activities, potentially setting some goals, targets, or deadlines as you see fit.

How often should I be meeting with my Associate PI Trainee?

We would recommend that you meet with your Associate PI Trainee at least once every 2 weeks to keep up to date on their progress, and to ensure they feel supported and are having a chance to undertake all the tasks on their checklist. Our feedback tells us that the PIs and Associate PI Trainees who obtain the most benefit from the scheme tend to work very closely together and meet on a weekly basis.

From a PI's perspective, what are the benefits of having an Associate PI?

We asked PIs who have mentored Associate PIs about the benefits of having an Associate PI. The benefits include:

  • having a 'second' that you can delegate tasks to
  • increased support with running the study at your site
  • playing a part in developing the PIs of the future
  • time to still perform your duties
  • more time to pursue your own research interests
  • more time to be a research leader
  • hopefully help you be able to go home on time
  • help take some pressure off of your research nurse
  • the study will get delivered more efficiently at your site
  • studies with Associate PIs have benefitted from enhanced recruitment
  • increasing the completeness and accuracy of study data

I am a PI. Does having an Associate PI change my legal responsibilities?

No, as the local PI you are legally responsible for the local delivery of the study and having an Associate PI Trainee work alongside you does not change this.

How much time am I expected to commit to mentoring an Associate PI Trainee?

We do not mandate a time commitment. However, based on previous PI feedback, an average of 30 mins per week has been suggested. Over a 6 month period, this time investment is more than offset by the trainee's contribution to supporting trial delivery.

How many Associate PI trainees will I be responsible for as a PI?

The general rule is that one Associate PI Trainee is permitted per study, per site. There may be more than one PI within a single trust for one study. For example if hospitals within a trust contribute to a study independently from each other, and if each hospital has a dedicated PI for the trial, there could be an Associate PI Trainee at each of these hospitals to work alongside each PI.

Please note, it’s important to be aware that an Associate PI Trainee is someone who is currently on their 6 month tenure, but has not yet completed the scheme. Whereas an Associate PI is someone who has finished their 6-month tenure, submitted a completed checklist, and successfully received a certificate granting them ‘Associate PI’ status.

If you are the PI for more than one study, provided that each of the studies is registered with the Associate PI Scheme, you may have an Associate PI Trainee for each of the studies you manage locally.

If you are happy to mentor more than one Associate PI Trainee for the same study at your site simultaneously, then we would be happy to accept this. We just ask that you inform the Associate PI Scheme team at associatepischeme@nihr.ac.uk so we know to expect two applications for the same site.

What should I do if I don’t feel an applicant is appropriate for the Associate PI Scheme?

We encourage anyone interested in becoming an Associate PI Trainee to speak to their local PI to gain their approval prior to applying to join the scheme. During this conversation, the applicant should be assessed against the eligibility criteria and the PI should decide whether it’s suitable for the applicant to take part in the scheme.

As the PI, if you feel that the applicant is not an appropriate candidate for the scheme, then please let them know during this initial conversation. If they go ahead and apply anyway, you can still reject the application when you receive the ‘Approve or Reject’ email from the Associate PI Scheme Team.

It’s advised that, in these cases, the PI speaks to the applicant to help them understand how they might make themselves more suitable in the future.
 

What is my responsibility in regards to signing off an Associate PI Checklist?

During their 6 month tenure on the Associate PI Scheme, the Associate PI Trainee is expected to complete and evidence all activities on the Associate PI Scheme checklist.

At the end of an Associate PI’s tenure on the scheme they need to have provided comprehensive evidence for all of the mandatory activities on the checklist.

When we say ‘comprehensive evidence’ we mean things like times and dates of attending meetings, official numbers of how many patients they have recruited (and dates and times of when), paragraphs of evidence of how they were involved in the study, etc.

Once they have completed their checklist, they need to send this to you as the local PI, for you to sign and date, so you can confirm that they have completed all of the activities outlined. Without your signature they cannot be formally recognised as an Associate PI.

It is therefore imperative that you as the local PI review this checklist thoroughly, because when you sign off an Associate PI’s checklist you are declaring that they have completed all the activities and should be formally recognised as an Associate PI.

It is essential that you uphold the rigour and status of the scheme by thoroughly reviewing this checklist. If you feel they have completed all the activities and should be formally recognised as the Associate PI, then you need to sign and date the Checklist and return it to the Associate PI (at which point the Associate PI needs to attain a signature from a member of the National Study Team, prior to uploading and submitting their final checklist copy).

More information

If you have any further questions please email associatepischeme@nihr.ac.uk

You can also visit our main page:

Associate Principal Investigator (PI) Scheme