The importance of monitoring in clinical trials

Monitoring provides ongoing oversight of trial quality and compliance. It detects protocol deviations, ethical breaches, and non-conformities with GCP. Through regular visits, the monitor verifies documentation completeness, source-data quality, and the informed-consent process. Acting on behalf of the sponsor and being independent of the site, the monitor guarantees objectivity.

Scope and cycle of clinical-trial monitoring

Monitoring spans the project’s entire life cycle—from site initiation to study close-out. The scope is risk-based and aligned with the ISO 13485 quality system guidelines. It verifies:

  • participant recruitment and adherence to inclusion criteria,
  • the informed-consent process,
  • clinical-data entry and reporting,
  • management of adverse events and source documentation.

Pre-study monitoring

The pre-study visit assesses site infrastructure, staff competencies, protocol familiarity, and document-storage procedures. At this stage the monitor confirms that the site meets the requirements to participate and aligns with the clinical-trial project assumptions.

Monitoring during trial conduct

During on-site visits the monitor checks:

  • correct recruitment and consent procedures,
  • data entry into EDC systems,
  • compliance with the protocol and GCP,
  • timely SAE/SUSAR reporting.

If non-compliance is detected, the monitor initiates corrective actions and provides staff training, ensuring data credibility and consistency.

Post-trial monitoring

The close-out visit completes the monitoring cycle and covers:

  • verification of documentation completeness,
  • secure archiving of source data,
  • return or disposal of investigational devices,
  • preparing the study for the results-reporting process.

Study closure must comply with GCP, ISO 14155, and local regulatory requirements.

Monitoring in accordance with GCP principles

All monitoring activities must follow ICH-GCP. The monitor must ensure that:

  • the study is conducted ethically and in line with the protocol,
  • participants are properly informed and protected,
  • data are complete, consistent, and verifiable,
  • processes meet sponsor and notified-body requirements.

The monitor’s role in ensuring compliance and quality

The monitor functions as an operational auditor, tasked with:

  • identifying non-conformities and procedural risks,
  • supporting the study team in corrective actions,
  • reporting progress to the sponsor,
  • working with clinical- and regulatory-risk teams, e.g. in risk management.

Expert support in clinical-trial monitoring

Pure Clinical provides end-to-end operational support for monitoring, including:

  • preparing monitoring plans compliant with MDR and GCP,
  • conducting training for study teams,
  • auditing sites and assessing operational readiness,
  • document control and compliance reporting.

How Pure Clinical supports clinical-trial monitoring

The Pure Clinical team delivers comprehensive, scalable monitoring support for medical-device studies:

  • planning monitoring strategies for single- and multi-site trials,
  • co-ordinating monitors nationally and internationally,
  • preparing control documents and visit reports,
  • ensuring compliance with ISO 14155:2022 and notified-body requirements.

FAQ

What competencies and qualifications should an effective clinical trial monitor have?

An effective monitor should combine GCP knowledge, experience in reviewing source data, and a strong grasp of regulatory documentation. Soft skills such as training ability, communication with sites and sponsors, and conflict resolution are equally important. In medical device trials, familiarity with MDR and ISO 14155 is highly valued.

What are the most common errors identified during monitoring visits?

Typical issues include incomplete informed consent documentation, delays in reporting adverse events, and data discrepancies between source records and the EDC system. Monitors also frequently detect protocol deviations related to improper storage of investigational products or outdated training logs for site staff.

How can technology support remote monitoring processes?

Remote monitoring is enabled by eSource, eISF, and integrated EDC platforms that provide real-time access to study data and documentation. Advanced tools also allow for virtual visits through secure video links and electronic audit trails. This is especially valuable for multicenter trials or in hard-to-reach study locations.

Should monitoring intensity be the same for every trial site?

No – monitoring intensity should be risk-based and tailored to each site's experience, protocol complexity, and GCP compliance history. Sites with higher operational risks may require more frequent and detailed visits, while well-established sites with strong records can be monitored remotely or through hybrid models.