Monitoring should generally include: keeping communication lines with sites and other parties (usually an assigned monitor per site), telling them about deviations from the protocol, GCP and regulation and acting to prevent recurrence with focus on important deviations, and telling them about entry errors and omissions so corrections are dated, explained and approved, all proportionate to importance; confirming site qualifications, resources and facilities, that staff are informed and follow the current protocol and IB, that essential records are kept, that consent preceded participation, that adverse events are reported on time, source record requirements and locations, that blinding holds, recruitment and retention, required reports and close-out arrangements for record retention and product accountability; confirming product storage, supply and shelf life, correct supply only to eligible participants at protocol doses and per randomisation, instructions on handling, documented receipt to disposition and compliant disposal; and verifying eligibility, checking reported data against source on a sampled and analytics-supported basis focused on higher-criticality data, identifying missing, inconsistent or outlying data, unexpected lack of variability and deviations, examining trends within and across sites, and spotting significant errors, possible manipulation and integrity problems. Monitoring reports should summarise what was reviewed, significant findings, conclusions, actions and follow-up of earlier open items, follow sponsor procedures on content and frequency, reach the right sponsor staff promptly, and identify findings needing escalation, with sponsor decisions and resolutions recorded.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.