A participant must give their consent before registration with the study. It is preferred that all local staff working on the study undertake good clinical practice (GCP) training at the frequency specified by their Trust.
This happens in two stages:
Give participant the study information sheet to read
The patient information sheet (and transparency information sheet) can be handed to the participant during their scheduled clinic visit.
If this is not possible, a telephone call should be made to explain the study. If the participant is interested, the patient information sheet (plus the transparency information sheet and a blank copy of the consent form, HAQ and EQ5D) should be posted to the participant.
If the participant wishes to be involved, the consent form should be signed and three copies taken (one for the participant, one for the notes/site file and one for the BSRBR-RA). Please note: only participants who agree to all sections of the consent form can be enrolled in the study. Each box on the consent form should be initialled to indicate consent.
If the consent form is being signed by the participant at home, they would sign and then post the consent form back to the hospital to be countersigned. A fully signed copy would then be posted to both the participant and to the BSRBR-RA offices.
For information on which forms to complete when registering a new participant, or re-registering a participant who is already on the study, please see the Registration information section.