For applicants
Eligibility criteria
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 six 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’ (e.g 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 for the Associate PI Scheme?
Students are not eligible to be Associate PIs, because the scheme requires significant input over at least six 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 for the Associate PI Scheme?
The Associate PI Scheme is aimed at clinical staff who wish to gain skills and experience in participating in NIHR portfolio research and to provide them with formal recognition of the contribution they have made over and above the standard expectations of their role. Staff whose core role already includes research (eg. Research Nurses) are therefore unlikely to benefit from the scheme. For this reason Research Nurses are ineligible to apply for this scheme. However we strongly advise looking at the NIHR Career Development web page.
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 for the Associate PI Scheme?
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.
Application process
How do I apply to become an Associate PI Trainee?
- 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. Please refer to the ‘Where can I check which studies are registered on the scheme’ FAQ below for further information on this.
- Speak to the Local Principal Investigator of the study to gain their approval before you officially register.
- Apply to join the scheme by completing the Associate PI Scheme Applicant Registration Form.
- Your application will be checked against our eligibility criteria and approval will be sought from your local PI via email.
- 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.
Please note, you are not officially granted ‘Associate PI’ status until you have completed your 6-month tenure and been issued with your certificate. During your time on the scheme you are referred to as the ‘Associate PI Trainee’ and will only be classified as an ‘Associate PI’ upon completion of the scheme.
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 should I apply to join the Associate PI Scheme?
We want Associate PIs to experience the running and delivery of a study and we advise that you will gain the most appropriate experience to complete the Associate PI checklist when the study is open and recruiting, so ideally, we want Associate PIs to apply to join the scheme when the study they want to contribute towards is already open and recruiting at their site. Your local PI will be able to inform you of what stage the study is in.
The study I want to contribute towards is in ‘Set-up’. When should I apply?
We want Associate PIs to experience the running and delivery of a study and we advise that you will gain the most appropriate experience to complete the Associate PI checklist when the study is open and recruiting.
However, we do allow Associate PIs to be involved in the set-up stage as this is still valuable experience. Having said that, prior to the Associate PI Trainee registering onto the scheme, we do enforce that the site needs to have at least sent the capacity and capability form to the R&D department so that we know the participant recruitment stage is imminent.
Where can I check which studies are registered on the scheme?
If you use our dedicated 'Where Can I Take Part?' tool you will be able to view a list of studies that are:
- Already registered onto the Associate PI Scheme.
- Open and Recruiting at the site where you work.
Here's the instructions on how to access the 'Where Can I Take Part?' tool:
- To identify a study that is registered onto the Associate PI scheme and open to recruitment at your local site, visit the Associate PI Scheme study dashboard and follow the instructions at the top of the page.
If you have any further questions please contact the Associate PI Scheme Team at associatepischeme@nihr.ac.uk.
I want to register to be an Associate PI trainee but the study that I want to be part of is not listed on the NIHR website. What should I do?
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 are only permitted to register to one study, at one site, at any time.
However, you can complete your 6 month tenure for one study, then apply again for a new study after you have completed the first tenure if you wish.
If 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?
Potentially yes. The Associate PI Scheme is guided by the studies available. The National Study Team, and local PI, would need to agree that your involvement in a study would enable you to meet the mandated Associate PI checklist criteria. If you meet this criteria, then you must first obtain approval from the local PI before you submit 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, such as:
- Gaining hands-on experience of research delivery.
- Gaining mentorship from an experienced PI.
- Gaining a foundation of research delivery knowledge to support you in your research career.
- Evidenced activity via the Checklist that can be used in training portfolio.
- Participation is recognised through certification for your training portfolio.
- Associate PIs may be acknowledged in the primary publication(s) from the study.
Taking part in the scheme
How long does the scheme take to complete?
Associate PI Trainees must be involved in a study at a single site for six consecutive months. This may be partly during the set-up phase and during follow-up of patients, but must include participant recruitment.
How do you complete the Associate PI Scheme?
To successfully complete the Associate PI Scheme and be certified with ‘Associate PI’ Status you must complete all mandated elements of the Associate PI Scheme checklist within your 6 month tenure. The checklist is made available upon successful registration, it includes elements such as participant recruitment, reviewing screening logs, etc.
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.
How many hours per week am I expected to complete?
We do not mandate how many hours per week someone must perform the Associate PI Trainee role, you can work it in and around your core role.
Associate PI Alumni have fed back that they were usually able to commit around 2-3 hours per week, but this is study dependent. It's always a good idea to have a discussion with your local PI prior to submitting your application form, to gauge how much time you will need to commit.
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?
Working in a primary care setting does not change the checklist activities nor the way in which you complete the checklist. The local PI who will be mentoring you through the scheme should be located at the same site as you.
If however you work within a Cluster/grouping of GPs and the local study PI is based at a different practice Please email associatepischeme@nihr.ac.uk and we can discuss your options further.
When am I officially recognised as an Associate PI?
You do not officially gain Associate PI Status until you have completed your 6 month tenure on the Associate PI Scheme and have been issued with your certificate after submitting your completed and fully signed checklist.
Once you have submitted your checklist and it has been deemed as a successful submission by the Associate PI scheme Team, you will receive a certificate that officially recognises you as the Associate PI.
Please note: You are not an Associate PI upon beginning your tenure on the Associate PI Scheme. You may be referred to as the Associate PI Trainee and you may use this title whilst you are on your tenure, but you will not be officially recognised as an Associate PI until you complete the scheme and receive your certificate.
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 free to act in whatever capacity you want, with agreement from the National Study Team and the local PI of course.
You will still be officially recognised as the Associate PI for that study, you just won’t be completing a tenure on the Associate PI Scheme as part of working on that study, as you will have already completed it.
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?
You must be working at the same site where the study is running in order for you to take part in the Associate PI Scheme. We are always looking for more studies to join the scheme, so if you discover a study that interests you at your site but is not registered to the scheme, then we would encourage you to get in touch with the National Study Team and introduce them to the scheme.
Can I take part in the Associate PI Scheme remotely?
No, you must be working at the site where the study is taking place so you can gain in-person mentorship from the local PI and get hands-on experience of delivering a study at a site.
Can I transfer/rotate from one site to another and continue as an Associate PI trainee?
Potentially yes, as long as the same study you are currently working on is also recruiting participants at your new site. If you are transferring to another site, you must make the Associate PI Scheme team aware by emailing us at associatepischeme@nihr.ac.uk and giving us the details of your new site, and who your new local PI will be.
You will also need to seek approval from the local PI at your new site to ensure that they are happy to mentor you for your remaining tenure time.
If there is already an Associate PI Trainee at the new site working on the study, then you will need to ensure that the local PI is happy to support both of you upon your rotation.
The Associate PI Scheme team will then follow this up and will also gain approval from the local PI.
Both your original local PI and the new PI at your new site will need to sign off your checklist. We recommend that you ask your original local PI to sign off the checklist before you leave your old site, then when you have finished your tenure at your new site, get your new local PI to add their name and signature.
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?
The first thing to do would be to speak to your local PI so they are aware of why you feel unable to continue on the Associate PI Scheme, as they may be able to offer support to help you continue on the scheme.
If, after speaking to your local PI, it is clear that you are still unable to continue on the Associate PI Scheme, then you must inform the National Study Team of your decision next.
Finally, once the PI and National Study Team are aware of your decision, you need to contact the Associate PI Scheme team by emailing us at associatepischeme@nihr.ac.uk.
If you are willing to, please do let us know the reason why you are unable to complete the scheme as it may help us improve the scheme moving forward.
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?
When your application has been accepted and confirmed, you will receive a link and enrolment key via email, this will grant you access to the NIHR Associate PI Scheme Learning Pathway in 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.
Completing the Associate PI Scheme checklist
How do I access the Associate PI Scheme checklist?
The checklist of activities you need to complete whilst on the scheme is stored online, within NIHR Learn. 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).
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?
You can add people to the delegation log, but the PI must sign these activities off.
Can an Associate PI Trainee sign off the delegation log?
No, The PI would still need to sign off the delegation log. Associate PI Trainees would assist in its maintenance ensuring the current team members are signed up, in-date CV/GCP, etc.
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 Trial Manager/Study Coordinator) 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. Both people will be cc’d into your confirmation email.
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.
For study teams
Study Eligibility Criteria
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, Sponsor, 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 the National Study Team.
- Engaging with and developing the local team to deliver a study.
To be eligible, studies must also:
- Sit under one of the supported NIHR Managing Specialties.
What is meant by ‘Managing Organisation’?
A managing organisation should be the national study team for example an R&D, Sponsor. 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 for Associate PIs 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 Commercial, is it eligible for the Associate PI Scheme?
Please email the Associate PI Scheme Team at associatepischeme@nihr.ac.uk to discuss this further.
My study is currently in the Set-Up phase, is it eligible to be registered on the Associate PI Scheme?
Ideally, we would say to wait until your study is open to recruitment before you apply for the study to join the Associate PI Scheme.
Studies that are in set-up can join the scheme - However if a study is more than 2 months away from opening to recruitment then it may be placed in a ‘Pre-registration’ status. This status indicates that the study will be eligible to accept Associate PI Trainees in future, but it does not allow any Associate PI Trainee applicant’s to register onto the study quite yet.
This is because an Associate PI Trainee’s time must include recruiting a participant, and their tenure only lasts six months. So if study set-up is going to take longer than 2-3 months, then we would rather not allow Associate PI Trainee applicants to start working on your study until the recruitment stage is a little more imminent.
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?
- Check if your study meets the study eligibility criteria. You can find this list of criteria a little higher up on this webpage, under the question: ‘What is the eligibility criteria my study must be in order to be registered on the Associate PI scheme?’
- 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.)
- Your application will be checked against our study eligibility criteria, and then approval will be sought 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). - 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 has a pending extension to the planned end-of-recruitment date, but the old date is on CPMS, is it eligible to join the Associate PI Scheme?
If your study has applied for an extension, the recruitment end date on CPMS must reflect the new end date as granted by the extension, prior to the study applying to register onto the Associate PI Scheme.
What do I do if I don’t think the study should be part of the Associate PI Scheme?
As part of the application process, we will seek approval from the Chief Investigator and Managing Organisation to confirm they agree with the study being registered onto the Associate PI Scheme.
If either party does not wish to take part, they can reject the study joining the Scheme. However we recommend both parties discuss their reasons with each other before rejecting the study.
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.
Associate PI Trainees taking part on your study
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.
To support study teams with this, we have created some promotional materials that can be found on our resources page. You can also find further support on how to engage your study sites and PIs in our National Study Team toolkit.
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.
Please note, 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.
The nominated representative will be expected to know who their Associate PI Trainees are and interact with them during their time on the scheme.
Associate PI Trainees should make contact with the nominated representative when they are confirmed for the scheme. However, we would also encourage nominated representatives to make contact with their Associate PIs to introduce themselves when an Associate PI is confirmed for the scheme, and explain to them what the role of the National Study Team is in delivering an NIHR portfolio study.
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 into the Dashboard and then look for the ‘For API Team Study Coordinators’ tab.
The dashboard will give you access to the data of who the Confirmed Associate PI Trainees are for your study(ies).
Please note, 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.
For further information on using the dashboard, please refer to the National Study Team toolkit.
Additional access to the dashboard can be granted to other members of the study team. Please email associatepischeme@nihr.ac.uk to request additional access.
Can there be 2 or more simultaneous Associate PI Trainees who are in the midst of their 6-month tenure, at the same site, at the same time?
Generally, most PIs will only be mentoring one Associate PI Trainee at a time. However, if the local PI is happy to mentor more than one Associate PI Trainee at a time then we will allow this. We are led by the capacity of the local PI. Please email associatepischeme@nihr.ac.uk to inform us if there are going to be two Associate PI applications for one site.
Signing off an Associate PI's checklist
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 should be the person who signs off an Associate PI Trainee’s checklist (this is normally the study coordinator or trial manager). However, technically anyone who is a member of the National Study Team can do this.
Certain activities on the Associate PI Scheme Checklist require review by the National Study Team Representative to confirm that the Associate PI did undertake those activities and has evidenced them well. These activities will have involved the Associate PI interacting with the managing organisation of the study, or are activities the managing organisation will have direct evidence of (e.g. completed delegation logs). National Study Team representatives are requested to check for evidence of completion of those checklist activities. Checklists should be signed off only if the Associate PI Trainee has properly completed and evidenced all core activities and already has the signature of the local PI. The ‘additional activities’ are 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 responsibility is taken by the person signing off the checklist?
The person signing the checklist on behalf of the National Study Team is taking responsibility for checking that the Associate PI trainee has fulfilled the necessary requirements to be recognised.
The National Study team representative will be able to assess how well or otherwise the study has performed at each individual centre. If a centre has performed badly with regard to local delivery of the study, the Associate PI checklist from that centre needs to be particularly carefully considered. If the National Study Team representative is not convinced that the necessary requirements have been fulfilled, the checklist should be returned to the Associate PI Trainee and local PI with feedback and recommendations about what further actions need to be undertaken in order to fulfil the criteria. It is imperative that CTUs uphold the rigour and status of the Scheme by making sure that the criteria have been met.
What should be done once the checklist has been signed?
Once the National Study Team Representative has signed the checklist it should be returned to the Associate PI Trainee so they can upload their completed and signed checklist on NIHR Learn.
The NIHR Associate PI Scheme Team will then process this and issue a certificate confirming Associate PI status.
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.
For Principal Investigators
Approving an Associate PI Trainee to join the scheme
What eligibility criteria must someone meet in order to apply to be an Associate PI Trainee?
Interested applicants must:
- Be a healthcare professional who wants to gain knowledge of what it means to deliver an NIHR portfolio trial.
- Be able to commit to six months of working on a study registered on the scheme at my local site, once their place on the Associate PI Scheme is confirmed.
- Have spoken to the local Principal Investigator of their chosen study and gained approval from them to join the scheme, prior to applying.
- Not currently work in a full time funded research role (e.g research nurse).
If they are a ‘Fellow’ (e.g Research Fellow, Clinical Fellow) then they must:
- Not be receiving funding to work on the study that they wish to contribute towards as part of the Associate PI Scheme. However, they can apply to join the scheme in relation to a study that is outside of their funded fellow role. Enrolment in these cases will be made on an individual basis.
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 available and as the local PI you would need to agree that their involvement in a study would enable them to meet the mandated Associate PI checklist criteria and the delegated duties are inline with the safety requirements in the study protocol.
Additionally, it’s important to be aware from a terminology perspective 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.
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.
Further information about approving a prospective Associate PI Trainee applicant can be found on our resources website.
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.
Further information about approving an Associate PI trainee can be found on our resources website.
When should an interested applicant apply to join the Associate PI Scheme?
We want Associate PIs to experience the running and delivery of a study and we think the best time they will get to experience this is when the study is open and recruiting. So ideally, we want people to apply to join the scheme when the study they want to work on is open and recruiting at their site. However, we do allow involvement in the set-up stage, as this is still valuable experience. Having said that, prior to the Associate PI Trainee registering onto the scheme, we do enforce that the site needs to have at least sent the capacity and capability form to the R&D department so that we know the participant recruitment stage is imminent.
If the study is already open to recruitment at your site, or is only 6-8 weeks away from opening at your site, then there’s no issue, timing-wise.
If the study is going to take longer than 8 weeks to open at your site, then you should not approve the application, and you should recommend that the applicant re-applies nearer the time the study is due to open.
Mentoring an Associate PI Trainee
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.
What are the benefits, for me as a PI, of having an Associate PI?
We asked PIs who have mentored Associate PIs what they felt the benefits of having an Associate PI are, and they fed back that 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.
- An Associate PI will give you time to still perform your duties.
- An Associate PI will give you more time to pursue your own research interests.
- An Associate PI will give you more time to be a research leader.
- An Associate PI will hopefully help you be able to go home on time.
- An Associate PI will 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.
- Having an Associate PI increases the completeness and accuracy of study data.
Expectations of the local PI
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 often becomes time neutral by the Trainees 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).