GCP Policy & Approach

Our nurses work both on site and in the home, on behalf of the PI as defined in section 4.1.5 of ICH GCP.

How is this achieved?

• The Nurses are included on the delegation log
• Nurse CVs are kept in site files
• Investigators are given the opportunity to comment on and add to the common nurse training developed centrally and approved by the Sponsor, as well as the Nursing manual which details all the activities of the Nurse in the home.

It is key that the nurses in the home are an integral part of the Investigator’s team, so communication must be smooth and effective between the on site nurses and their partner homecare nurse; this ensures continuity of care for the patient.

As well as direct communication, processes must be in place to ensure the site staff review the data recorded on the Visit Report Form (VRF) by the home based nurse team.