Follow-up, Data Collection & Safety
Follow-up
The REGAIN Team at Warwick Clinical Trials Unit will manage the follow-up of participants directly.
Follow-up questionnaires will be completed by the participant at 3, 6 and 12 months post randomisation directly onto the REGAIN Database.
Assessing and Reporting AEs, SAEs and Related SAEs
Assessing and Reporting AEs, SAEs and Related SAEs
AEs and SAEs to be recorded by the exercise practitioner on the AE log, if they occur:
- During REGAIN Live Online Session
- During REGAIN on demand exercise session
- Within 24 hours of live online session
- Within 24 hours of on-demand exercise session
Serious adverse events
Only SAEs that occur from the time of randomisation, through to and including 30 days after cessation of trial intervention, must be reported to WCTU
The completed SAE forms (initial and follow-up) should be emailed to wctuqa@warwick.ac.uk and REGAIN-RS@warwick.ac.uk within 24 hours of the research staff becoming aware of it or as soon as is practically possible. Please ensure you follow the NHS encryption guidelines.
All participants experiencing SAEs will be followed-up until the event has been resolved or a final outcome has been reached as per protocol until the end of the trial.
Possible SAEs include (but are not limited to)
Events that are common in this population and those that are collected as outcomes of the trial should not be reported as SAEs.
- Results in death
- Is immediately life-threatening
- Requires hospitalisation or prolongation of existing hospitalisation
- Results in persistent or significant disability or incapacity
- Is a congenital abnormality or birth defect
- Intervention is required to prevent one of the above or is an important medical condition