eCRF Completion

Q.  Baseline bloods – can the results be from different days?

A. Yes, as long as the bloods are not older than 4 weeks prior to randomisation, blood results can be taken on different days.

Q. Baseline bloods – if any of the tests weren’t done (e.g. not part of routine care) then please record which test wasn’t done and why in the ‘Notes’ section of the relevant form. We will then know not to query why the result is missing. The only exception is for results which are part of the inclusion/exclusion criteria, as these tests should always be carried out (e.g. Hb, ALT/AST).

Q. For the in hospital bloods we have more than one set of blood results covering the days requested, which should we use (e.g. for Day 2-3 we have bloods for both days)?

A. Both sets of bloods results would be correct, but if you have a set which matches with the exact POMS days then it would be better to use those (e.g. for the above example you would use the Day 3 bloods, as this matches the Day 3 POMS collection).

Q. Do we need to ask the patients to complete the baseline SQOM?

A. Yes, even though the patient has only just been randomised into the trial, they still need to complete the baseline SQOM.