UK Follow-up and data collection
Follow-up is done by completing an online Case Report Form around the time the participant is discharged from hospital, dies, or 28 days after randomisation, whichever is sooner. If you have been assigned the role of completing these important forms, please ensure you have completed the background and follow-up training.
A sample follow-up form can be downloaded but please note it is an example. We will contact staff who have been nominated to complete these with details of how to log-in. If you wish to contribute, please contact your LCRN. These follow-up forms are essential for the trial so thank you for completing them carefully and for all your help with the trial.
All case report forms must be completed online. Please note: only data relating to events during the first 28 days after randomisation should be reported on this form.
ADVERSE EVENT REPORTING
The protocol states that adverse events only needed to be reported if they are both (a) serious, and (b) believed to be related (with reasonable possibility) to the study treatment, in the opinion of the local principal investigator. Any other adverse events (serious or otherwise) do not need to be reported. Please report relevant adverse events (i.e. those that are both serious and believed to be related) using the trial systems. The MHRA Yellow Card system is for reporting adverse drug reactions outside trials so please do not use this for RECOVERY participants.
Serious adverse events are defined as those adverse events that
- result in death;
- are life-threatening;
- require in-patient hospitalisation or prolongation of existing hospitalisation;
- result in persistent or significant disability or incapacity;
- result in congenital anomaly or birth defect;
- or are important medical events in the opinion of the responsible investigator (that is, not life-threatening or resulting in hospitalisation, but may jeopardise the participant or require intervention to prevent one or other of the outcomes listed above).
The focus is on those events that, based on a single case, are highly likely to be related to the study medication. Examples include anaphylaxis, Stevens Johnson Syndrome, or bone marrow failure, where there is no other plausible explanation.
SERIOUS ADVERSE EVENTS
If you believe that a serious adverse event has occurred which is believed to be related to study treatment, please call the central study team on 0800 1385451 and we will collect the necessary details. Before doing so, please download the sample Serious Adverse Event form and ensure you have the information in there to hand when you call.