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Monitoring on a typical interventional study follows a recognisable sequence of visits, each with its own purpose and report:

1. Site qualification (pre-study) visit: confirms that the investigator, staff, facilities, patient population and equipment can support the protocol, and that recruitment targets are realistic.
2. Site initiation visit: trains the site team on the protocol, informed consent process, case report forms, investigational product handling and safety reporting before the first participant is enrolled.
3. Interim monitoring visits: review consent, eligibility, protocol adherence, adverse event reporting, drug accountability and the investigator site file, with frequency set by the monitoring plan.
4. Close-out visit: reconciles outstanding queries, investigational product and essential documents, and confirms archiving arrangements.

Each visit ends with a monitoring visit report and a follow-up letter to the site listing findings and agreed actions, which become part of the trial master file.

ICH E6(R2) encouraged sponsors to move away from checking every data point at every visit towards a risk-based quality management approach, and ICH E6(R3), adopted in January 2025, builds further on proportionate, risk-based oversight. In practice this means identifying the data and processes that are critical to participant safety and the reliability of results (such as primary endpoint data, eligibility and consent), then focusing source data verification and site visits on those areas.

Centralised and remote monitoring complement on-site work. Central review of accumulating data can detect unusual patterns across sites, such as implausibly uniform measurements, delayed adverse event entry or outlying enrolment rates, and trigger a targeted visit. Remote review of source documents is used where local data protection rules and site systems permit it. The monitoring plan should state which methods are used, how often, and what triggers escalation.

Monitoring is an ongoing activity carried out by the sponsor's clinical research associates during the study. An audit is a systematic, independent examination of trial conduct, documents and systems to judge whether the study complies with the protocol, standard operating procedures, GCP and applicable regulations. Audits may be scheduled for high-enrolling or high-risk sites, prompted by monitoring findings, or carried out on systems such as the electronic data capture platform or the trial master file before a regulatory inspection. Findings are graded by severity and followed by corrective and preventive action (CAPA) plans.

Monitoring findings affect what happens later in a study. Protocol deviations recorded at sites feed into the definition of analysis populations, data queries affect database lock timelines, and safety findings shape narratives in the clinical study report. Close coordination between monitors, data managers and biostatisticians reduces late surprises. Background on the guideline framework is available in Pubrica's overview of ICH guidelines in clinical trials and drug development, and downstream documents are covered under regulatory writing. To discuss monitoring requirements for a specific study, contact the clinical team with the protocol phase, number of sites and countries involved.