Central Monitoring - Sending Consent Forms to a Coordinating Centre

[MonitorH]

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. 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.

[thanhbinhvhks]

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.Hoa tươi hà nội 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.

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.

[MHRA Moderator]

As stated in the MHRA GCP Guide, a formal system should be in place that complies with the Data Protection Act 1998 to ensure access to the confidential information is restricted and that the subjects of the clinical trial are aware that a sponsor or third party may have access to their data (as mentioned in the earlier MHRA post). Therefore, the process used to transfer the information following a subject’s consent should be considered and risk assessed to ensure that only the intended recipient receives the fax/email containing identifiable data.