Consent

Q. The protocol mentions offering patients 24 hours to consider the patient information sheet and any other information provided before consenting them. How will this work with the visits?

A. The patient should be given the option of 24 hours. In practice many may happy to consent sooner and not require this long. Patients can also be contacted by telephone in advance of clinic visits to discuss the trial and the patient information sheet can be sent using the approved patient invite letter.