CRF/eCRF

Q. If the patient was taken to another hospital first, then transferred, which door time is the one required?

A. Door time is the time of arrival at the PPCI centre i.e. your hospital.

Q. Where should I record medications that are given in the ambulance?

A. This can be recorded in the Pre Procedural and Peri-procedural Drugs under the Index Admission form.

Q. The LVEF value has been reported as 25-30%, how do I record this in the eCRF

A. When LVEF is reported as a range rather than a single value it is better to record this as the midpoint value on the eCRF with an explanatory note in the notes section e.g value reported is 25% – 30%, recorded 27% in the eCRF. The reason for this is that it is very difficult to include ranges in the statistical analysis of the data.

Q. I can’t save a form in the eCRF as the data is incomplete

A. A draft version of the form can be saved by waiting 10 seconds within the form and then clicking “return to patient”. A pop-up box will appear and “OK” should be clicked. When the additional data is received, click to “add” the form and then “load draft”. The additional data can be added and the form saved. Please note though that the data is not submitted until you enter your password to save the form and the form will continue to appear as overdue until it is submitted.  

Q. I’ve noticed a mistake on the form that is already saved

A. Edits to the eCRF can only be made by Matt or Steve. Please “Create a query” within the form outlining the changes required and we will make the amendments.

Q. What point are the follow-ups measured from

A. Follow up is measured post-randomisation, not post PPCI or post discharge.