Link to the randomisation website...
Please go to https://www.pc-crtu.bham.ac.uk/rossini to access the ROSSINI randomisation website.
Please note this site will require a username and password. If you do not have these please contact the trials office.
Guidelines for Surgeons...
Information on how to open a new site...
The Rossini team are interested to hear from sites wishing to participate in the trial. If your centre would like to participate, please read through the information below and contact the trials office.
Each site will need to identify a Principal Investigator who will be a consultant surgeon. Their role will include a number of responsibilities:
day-to-day responsibility for the conduct of the research
ensuring the protocol is followed correctly
ensuring participants receive appropriate care during their involvement in research
maintaining the integrity and confidentiality of records
reporting adverse events.
Participating sites may also identify additional researchers (likely to be surgical consultants or registrars) who will be involved in the recruitment and follow up of patients during the trial. All clinicians involved in recruiting and consenting patients for trial must have completed the Good Clinical Practice Course. Most trusts will be able to provide this free of charge. Alternatively the course can be completed online via the GCP website for a moderate fee.
All research sites will require local R&D approval as well as approval by the Trust Management before any patients can be recruited. The ROSSINI trials office will assist with these processes and complete much of the other paperwork required.
In order for us to begin the process of adding your site, please contact Jenni Bradbury at the trials office with the name and CV of the Principal Investigator.
For help with opening a new site, obtaining access to the randomisation website or any other queries about the day-to-day running of the trial please contact the trials office at:
ROSSINI Study Office,
University Hospital Birmingham NHS Trust
Queen Elizabeth Medical Centre
Birmingham, B15 2TH
tel: 0121 627 2283
For any other information or queries regarding ROSSINI please contact Tom Pinkney (firstname.lastname@example.org) or Dave Bartlett (email@example.com)