Central Monitoring - Sending Consent Forms to a Coordinating Centre
We are increasingly being asked to send copies of consent forms to coordinating centres for central monitoring purposes. Does any one have any advice on whether this is acceptable? In some instances the REC application doesn't mention that this will be happening and neither does the monitoring plan.
Is it sufficient that the consent form says something along the lines of 'data collected during the study may be looked at by individuals from the research team, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research' or should the PIS specifically say that consent forms will be faxed to the coordinating centre?
Appreciate any advice - thank you
Sending Consent Forms to a Coordinating
[QUOTE=MonitorH;2506]Caterineta - in the situation you have outlined, the patient should be informed via the Patient Information Sheet that a copy of their signed ICF may have to be provided to the head of the pathology department and why.[URL="http://dienhoatuoi.net/dien-hoa"]Hoa tươi hà nội[/URL] There should then be a statment on the ICF for the patient to confirm they explicitly consent for this to be done. In that way, the patient is informed about who gets to see their ICF and has consented to this.[/QUOTE]
[COLOR=#333333]The fax may go to a wrong number and also not all fax machines are password protected such that only the authorised recipient has access to the output.[/COLOR]