PEACHY has HRA and REC approval as a non-consenting study- 18/WM/0394
Training is available online here: https://www.niaa.org.uk/Introduction-to-Good-Clinical-Practice-e-learning
To complete the module you will first need to register with the NIHR Learning Management System to create an account using your NHS or university email address.
No, as PEACHY is a non-consenting study
Your site will be accepted into the study once you have submitted your registration form.
PEACHY has been approved as a multi-centre study. Registered sites will be added as a non-substantial amendment to the IRAS form as sites formally register; this can take four weeks from submission and an updated version of the IRAS form will then appear on the study website.
The study requires agreement between the sponsor and your Trust R&D therefore please register as a Trust. For registration purposes, choose a trainee, local lead and main R&D contact to manage the study across the sites.
In the Organisation Information Document (OID), please add each separate hospital/site in your Trust under Section 6.
No, the local Principal Investigator needs to be part of the clinical team as per our ethics agreement. This should be a Consultant with up to date Good Clinical Practice training.
This is a local assessment made by your R&D team. Please liaise with them directly and they will guide you through the process to get your site set up for the study.
No this is not required. Ethics approval has been gained through the sponsor site, University Hospital Southampton.
No, there is no additional funding. The study is a trainee led project and should be largely delivered by trainees, as has been the case for previous national PATRN projects.
Your site will collect data for a one-week (7 day) period only. The recruitment window is from 9th September 2019 to 6th October 2019 to allow you some flexibility in when you conduct your data collection.
We based our initial estimates on the PAPAYA numbers of around 90 sites. This project, while starting as a similar audit, has grown into a NIHR portfolio study therefore the sign-up process is a little more robust. We currently have around 70 sites registered.
There is no set number of cases each site should recruit. The absolute numbers will vary from site to site as we will be recruiting from small DGHs to large tertiary centres. The important thing is that each site collects data for ALL eligible children in the study period.
No. If you have specific queries with regard to the set-up process, please direct these to the PEACHY team (email@example.com) but we are hoping that most of the information you require will be available via the study website.
There will be some patients (eg with an acute abdomen or musculoskeletal problems) that you may not be able to measure a standing height. If this is the case please follow your local policy for measuring height lying down or sitting. If this isn’t clarified within a local policy, a supine height, with the patient lying on their bed (ideally with feet against the footboard) would be acceptable.
If you are unable to measure height at all for a patient please start a case record form (CRF) for the patient but do not collect any further data. This case will then be uploaded as a “missed” case. This will mean we know how many cases we have missed and have not been able to calculate a BMI for during the study period.