Research Roadmap

Quality control (monitoring)

Monitoring is an essential instrument for the quality assurance of research subject to the Medical Research Involving Human Subjects Act (WMO). It ensures that the rights and well-being of participants are protected, that study data are recorded accurately, completely and verifiably in source documents, and the study is conducted in accordance with the approved research protocol (including amendments) and all relevant legal requirements.

At Amsterdam UMC, monitoring is mandatory for all research subject to the WMO, in line with the NFU Guideline Quality Assurance Research involving Human Subjects. The sponsor (in Dutch: verrichter) of a study is responsible for ensuring adequate monitoring.

Monitoring activities must be carried out by qualified monitors (clinical research associates) who are not involved in the conduct of the study (i.e. independent party). Independence is crucial to allow objective verification of both proper study conduct and documentation.

Monitoring by the Clinical Monitoring Center Amsterdam UMC

For all investigator-initiated studies sponsored by Amsterdam UMC and subject to the WMO, independent monitoring is provided by the Executive Board, which delegates this responsibility to the Clinical Monitoring Center (CMC).
The CMC website provides information on how to request monitoring, associated costs for participating centers, and additional services and support..

During the study, monitoring is performed according to the monitoring plan. The frequency and intensity of monitoring are determined by the NFU risk classification and agreements within Amsterdam UMC, in line with the NFU Guideline Quality Assurance Research involving Human Subjects.

Note: Monitoring activities performed by the CMC on behalf of Amsterdam UMC-sponsored trials are financially compensated by the Executive Board; the principal investigator (PI) will not be charged. Monitoring services provided to participating centers are the responsibility of the PI. A calculation tool is available for an indication of the costs based on the study type, risk classification and study duration.

To request monitoring by the CMC, contact: cmc-diensten@amsterdamumc.nl

External monitoring

When monitoring is outsourced to an external party (e.g. a CRO or freelance CRA), the PI must ensure that the monitor is qualified and that all monitoring activities are conducted according to a monitoring plan and monitoring SOPs.

Please note that due to privacy and safety policies, remote monitoring of participant data in EPIC is not allowed. Amsterdam UMC has a specific procedure in place for requesting an EPIC account for external monitors.

Quality Assurance

The Executive Board of Amsterdam UMC holds ultimate responsibility for all research involving human subjects conducted at Amsterdam UMC. To safeguard this responsibility, an internal quality management system has been implemented in accordance with the NFU Guideline Quality Assurance Research involving Human Subjects and Good Clinical Practice (ICH-GCP).

As part of this system, an independent Quality Assurance Clinical Research team has been appointed within the staff department Patient Care. This team is delegated to develop, maintain and optimise the overall policy framework for research involving human subjects at Amsterdam UMC.

Other tasks of team Quality Assurance Clinical Research include:

• Implementing and performing a risk-driven assessment program consisting of systematic audits (focustracers) and quality checks on compliance in research conduct;
• Providing feedback to the organization, departments, researchers and the Executive Board on risks and trends in findings, along with advice on opportunities for improvement;
• Coordinating the assessment and reporting of escalations arising from conducting research involving human subjects;
• Actively monitoring new or revised legislation and guidelines related to research involving human subjects, and providing information to the organization;
• Providing overarching support, advice and (improvement) initiatives related to quality assurance in research involving human subjects;
• Providing guidance in case of inspections/accreditations.

For questions, contact QAresearch@amsterdamumc.nl