Local Lead Study Guide
Welcome to the POPPY study team! We hope that you enjoy taking part and find the information below as a useful guide to setting up POPPY at your hospital. It is designed to help PIs and Associate PIs navigate the process of setting up the POPPY study at sites.
We hope this alongside a virtual group site initiation visits will be sufficient to ensure that local research teams feel confident in doing this study at their hospitals.
The POPPY Study is affiliated with the Associate PI Scheme (applications now closed).
Our top tips for success
Learn about the study
You can learn about the POPPY study by reading through our study documents and watching our recordings of the site initiation visit and tutorials. These videos will will give you a brief overview of the study, information on how to register your site with the POPPY platform, and how to input participant data. All participant data is put on electronic CRFs on the POPPY NewcastlePROMs secure online platform. Each site will need to register for one account that will be shared within your research team.
Local Information Pack
Your PI, research and development contact provided to us and trainee lead will receive a full local information pack by email. This will have all the information to get local site approval from your R&D department.
Liaise with your local R&D department in regards as to how you store documents related to the study locally.
Documents you will need to return to our sponsor:
Before the study in order to get green light your must send:
Organisation Information Document (OID): this is an agreement between the study sponsor (University Hospitals Plymouth) and the participating NHS organisation for studies. Your R&D department will be familiar with this document and should be involved in the process of completing this. It is quite a long document and may therefore seem quite overwhelming. We have pre-populated the relevant areas and should just require review by R&D and signing off.
Confirmation of capacity & capability: you should contact your R&D office as soon as possible and make sure that they have received the LIP (local information pack) in order for them to do a capacity & capability assessment. As part of this the R&D office will assess the impact the study will have on the organisation and it is feasible to take part. They may ask you to fill in forms such as a feasibility form as part of this process. If your research team is made up of anaesthetists it is helpful to remind your R&D department that they will not need to provide further staff.
CV and GCP for your Principle Investigator: in addition to this a small random selection of sites may be asked to send our sponsor copies GCP certificates for all local collaborators.
Above documents must be sent to:
Copy of the delegation log: you are required to send an initial copy of your site delegation log to our trial sponsor.
The most important thing to do is engage your Research and Development departments as soon as possible in order to achieve the above in time to be issued green light by our sponsor. In the past we have found that picking up the phone and having a chat is usually much more effective than a long email trail. Talking to R&D colleagues is also a great way to build professional links and learn from colleagues.
During the study:
Copy of the first 5 consent forms: our trial manager at UHP requires you scan and email a copy of the first 5 consent forms, if there are any issues with these you may be asked to send a further 5 consent forms.
Organise your team
The aim is to recruit all day case patients to POPPY during the 5 days, or as many as you can! This is not a one person operation but rather a team of local collaborators a helping with screening, recruitment and data collection. Local collaborators can be anaesthetists, research nurses, surgeons, medical students and other members of your wider research team. All collaborators should have their GCP in date. All local collaborators will receive a certificate, be able to use their involvement as evidence under the new RCoA curriculum and will be included in all future publications under our shared authorship policy.
The POPPY platform
The POPPY platform is a data secure, easy to use online platform where you will register your site and input participant data. That's right, there will be no paper CRFs! You will be able to use the platform on all electronic devices including tablet and smartphone devices. PIs/associate PIs/local leads will be asked to create a single login for your site with a shared password that all local collaborators will use to input data. The platform has been designed to be easy to use. Once you have a local team of collaborators please send them our tutorial so they can learn how to use the platform.
Pick your dates
The POPPY study will take place over 5 consecutive days over a 4 week study window starting on January 15th 2024. If you are an anaesthetist your department should be supportive in allowing study leave and SPA time for the POPPY study as involvement hits key parts of the RCoA Research and Managing Data module with trainee research network activity mentioned in all three stages under personal activities.
Learnt about the study and attended/watched the SIV?
Sent us your OID and capacity & capability confirmation?
Got a team together and checked they are up to speed?
Registered on the POPPY platform?
Picked you 5 day window?
...sounds like you're ready to go!
Tips from an Associate PI who did the pilot study
Sam was an anaesthetic core trainee when he was the local lead at Derriford Hospital during the POPPY study pilot phase this summer. He also took part in the NIHR Associate PI Scheme. Below are some of his tips that you might find helpful.
Work out how many admissions areas you have to give rough number of collaborators required each day. I aimed for minimum of 5 of us per day, but in practice (due to the strikes) we had far fewer than that for days 1 & 2, and it was fine. I asked trainees, research nurses, med students and trainee AAs. Most were recruited face-to-face (no-one really responded to departmental emails or WhatsApps!). I made an excel timetable showing each study day / location to help allocate volunteers. On the day, team allocations can be fluid - when all patients have been recruited in one area, redeploy the team to help with other areas.
Communication and education:
Reach out to key stakeholders; matrons / lead nurse / lead preop anaesthetist in each area. Meet nursing staff and put poster in admissions areas. I spoke at the admission nurses’ meeting during CME which had a good response. It’s really important that the nurses are briefed what to say to patients and don’t try to recruit them or influence their decision to take part or not. Put a poster in each anaesthetic / coffee room etc. I emailed the college tutors several weeks before the study to ensure that trainees getting involved in data collection could get EDT/study leave - mention that it’s relevant to the LLP / GCP curriculum and they should be fine! The week before, also send a department-wide email about POPPY. I also used the departmental WhatsApp group to remind all consultants that their patients may be recruited, and to flag to us any day case patients who hadn't been recruited.