Recent Updates
Update on the use of personal data by NHS sites: click here for more information
Top Recruiter January 2018: Royal Victoria Infirmary
Congratulations to Royal Victoria Staff for a strong surge towards the end of the trial. Keep it up!
Top Recruiter November 2017: Coventry and Warwickshire University Hospitals
Thumbs up to the team for being top recruiters- again!! Keep up the amazing job you're doing!
Top Recruiter October 2017: Leicester University Hospitals
Many thanks to the team in Leicester for recruiting 16 patients in October! Keep up the good work!
13 November 2017 Teleconference
We will be holding another teleconference to discuss burning issues. Please email white4@ndomrs.ox.ac.uk for more details.
Top Recruiter September- Queen Alexandra Hospital
Many thanks to the research team in Queen Alexandra Hospital, Portsmouth for randomising patients into White4!!!
Top Recruiter- August: Coventry and Warwickshire University Hospitals
Thumbs up to the team in Coventry for recruiting 8 patients to WHiTE 4 trial in August!
25 September 2017 Teleconference
We will be holding a teleconference for all participating sites for sharing their experiences and concerns about the trial. We'll discuss how to optimise general trial procedures ( screening, consent process, data collection) with the focus on recruitment. For further details, please email white4@ndomrs.ox.ac.uk
Top Recruiter- July: Southmead Hospital, Bristol
Well done for recruiting 9 patients, Southmead team!
10 August 2017 Data Lock
Our next DSMC will take place on 6th September 2017. We will be doing an interim data lock of all participants recruited until the 10 August for this meeting. Please return all participant information (forms, CRFs and resolved queries) to the Trial Office by this date.
All WHiTE Trials Combined Screening Log
A new combined screening log has been released and is in use from July 2017 on. If your site participates both in WHiTE Cohort and in one of the WHiTE RCTs, you will only need to complete one log for both trials!
13 July 2017 Amendment 08
The protocol has been amended and includes a change in the sample size to 1128 patients and recruitment period is extended until February 2018, due to higher than anticipated loss to follow-up.
01 February 2017 - 400th participant recruited!
The research staff at Royal Victoria Infirmary recruited our 400th participant today. Thank you all for your hard work with screening and recruitment of participants to WHiTE Four!
01 February 2017 - DSMC Meeting April 2017
Data Lock - We will be doing an interim data lock of all participants recruited until the end of 2016 for the upcoming DSMC meeting. Please return all participant information (forms and CRFs) to the Trial Office by February 17th, 2017
16 January 2017 - New Screening Log
Following requests for clarification on what should be included in the WHiTE Four screening log, we have changed the screening log to ensure that the data captured is only related to pre-trial entry, and does not include post-randomisation information (e.g. re consent) as this is collected elsewhere. Please now use version 2.0 of the screening log, preferably in digital (Excel) format, to record screening information for WHiTE Four.
13 January 2017 - New Information Governance Regulations
Following a recent request from the University of Oxford's Data Protection Office, we are now requesting that all documents that contain patient identifiable data (e.g. consent forms, trial entry forms & patient contact details for follow-up) be sent to the trial office only via secure nhs.net email and not via post. Our secure email address is orh-tr.white4@nhs.net.
04 October 2016 - Amendment 04
The protocol has been amended and includes a very minor change (dat correction in header). The WHiTE Four Protocol Version 4.0 03 October 2016 is now the most current version of the trial protocol and is the only version which should be in use. Please put the previous version of the protocol in the superseded section of the Investigator Site File and use only the new versin from this point forward.
