Monitoring is one of the core activities of a clinical trial. It is organised around visits to investigator sites, each with a specific purpose. Understanding their role helps scope an assignment — and know what to expect from it.

The four main types of visit

Selection visit. Before opening a site, its ability to run the study is assessed: experience of the investigator team, available patient population, facilities, compliance with good practice. The goal is to avoid opening a site that will not enrol or cannot follow the protocol.

Initiation visit. Just before start-up, the team is trained on the protocol, procedures and regulatory obligations. Essential documentation is checked and the site is confirmed ready to include the first patient.

Monitoring (routine) visits. During the study, the CRA checks data, patient safety and protocol compliance. This is the heart of the work: source data verification, follow-up of adverse events, management of deviations and corrective actions.

Close-out visit. At the end, documentation is finalised, materials and treatments are reconciled, and archiving is prepared.

What risk-based monitoring changed

For a long time, monitoring relied on exhaustive data checking (100% SDV). The ICH E6(R2) addendum to Good Clinical Practice established a risk-based approach: focus effort on the data and processes that are critical to patient safety and result reliability, rather than checking everything the same way.

In practice, this means:

  • identifying the study's major risks up front;
  • combining on-site and centralised monitoring;
  • adapting the frequency and intensity of visits to the actual level of risk.

For a CRA, that means less mechanical checking and more judgement: knowing where to look, and why.

In short

Each visit addresses a stage of the study's life cycle — from selection to close-out. Well-run monitoring doesn't "tick boxes": it anticipates risks where they truly matter.

Need monitoring support across your sites? Let's discuss your project.

Source: ICH E6(R2) Good Clinical Practice (addendum, 2016) — risk-based approach to quality and monitoring. Last updated: November 2026.