MACRO DATA ENTRY

Q. How should I record NIHSS Score within MACRO?
A. There are two different eCRFs that request different NIHSS values. The Screening eCRF requests NIHSS Score at time of hospital admission, while the Randomisation eCRF requests NIHSS Score at the point of randomisation. This latter value should be consistent with the range entered into Sealed Envelope while performing randomisation.

Q: A warning on MACRO came up for a participant whose diastolic blood pressure was high. This was the correct value
A: In this instance, please right-click the appropriate field and choose to add a comment explaining this value is correct. The data manager will then observe the comment and ensure the validation warning is overruled.

Q: I have noticed that you require us to enter the time and date of first dose of DOAC. The patient was randomised for the standard initiation (7-14 days), however my patient has already been discharged. What do I do?
A: This data is very important to collect as we need to ensure the DOAC was taken within the allocated timeframe of the standard initiation arm. Please contact the patient or their treating team to get this information.

Q: Should I report outcome events even if they are not an SAR or SAE?
A: An outcome event form should be completed for all outcome events, regardless of classification as an SAE or SAR or not. Please see Figure 3 of the study protocol (safety reporting flow chart) for more details.

Q: What medications needs to be added in the medication log?
A: You need to add ALL medications the patient is taking. This includes the DOAC that is prescribed to the patient.

Q: When do we add the medication information? What about medication taken before consent?
A: You need to add ALL medications in the medication log, even ones taken before consent.

Q: I’m filling in the Medication Log, and a patient is still taking their medication. When I leave the “End Date” blank, the form is flagged as having missing data. What should I do?
A: Simply right-click on the “End Date” field, and navigate to Change Status -> Not Available. Once this information becomes available, you can change the status back to Missing and then enter the data. This method can be applied to any appropriate field, not just the Medication Log.

Q: I keep getting validation warnings when entering a figure/answer, but my data is correct. I can’t override this warning, so what should I do to let the trial team know?
A: MACRO includes a comment function, to allow you to add additional text to any field. Right-click on the appropriate field, and navigate to Comment -> Add. Simply write the information you’d like to amend, and then click Close.

Q: When we record the concomitant medication, if it is medicine that the patient has been taking since before admission, do we need to say the start date as when it actually started before admission?
A: If possible, please add this information. However, we know historic medicine may not always have a known start date. The medication log accepts partial dates if the participant remembers at all, e.g. Jan-2010, or 2010, but if it is not available, you can right-click the start date and change it to "Not available”.

Q: Creatinine Clearance is  marked as not acceptable, for example if it is 57 - it says it is too low
A: You will notice that although a warning pops up stating that the creatinine clearance level is out of the expected range, the value is not rejected. When this happens, please right-click on the field and choose to leave a comment. Write something along the lines of "value is definitely correct". This will allow the data manager to easily clear the warnings when reviewing participant records.

Q: If a participant is recruited to OPTIMAS and has been moved from the stroke unit(s) to a general ward in the same hospital, does the discharge from the stroke ward count as discharge in order to complete the discharge CRF OR should discharge be when the participant is discharged and leaves the hospital?
A: The discharge form should be completed when the participant leaves the hospital.