Frequency and plans for auditing trial conduct {23}
RECRUITMENT
Members of the UK-based research team will carry out monitoring visits to ensure that research activities are being implemented as outlined in agreed protocols and SOPs and in accordance with ethical guidelines and data protection legislation. This will include checking the secure storage of electronic and paper records/data, the correct completion of agreed recruitment and enrolment logs and case report forms and accurate data entry.Further monitoring, audit and inspection will be carried out annually by independent local research bodies within the local institutions.