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 UMCNL 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 UMCNL risk classification and agreements within Amsterdam UMC, in line with the UMCNL Guideline Quality Assurance Research involving Human Subjects.

Note: Monitoring activities performed by the CMC on behalf of Amsterdam UMC-sponsored studies 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 standard operating procedures. 

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 participants conducted at Amsterdam UMC. To safeguard this responsibility, an internal quality management system (QMS) has been implemented in accordance with current legislation and regulations, such as the ECTR, ICH-GCP, MDR, WMO, and the UMCNL Guideline Quality Assurance Research involving Human Subjects.

For that purpose, for example, the Research Code was developed, as well as the Research Policy on Medical Scientific Research Involving Human Participants. Links to all current guidelines, policies and standard operating procedures are available via the Policy Framework page.

As part of the QMS, an independent team Quality Assurance Clinical Research (QA) has been appointed within the staff department 'Dienst Patientenzorg'. Team QA is delegated to develop, implement, maintain and optimise the overall policy framework for research involving human participants at Amsterdam UMC. 

Responsibilities of team Quality Assurance Clinical Research include:

• Maintain the Quality Management System (QMS);
• Develop and maintain policies and hospital-wide procedures for the conduct of research involving human participants;
• Implement and translate applicable legislation and regulations into Amsterdam UMC policies and procedures, while actively monitoring new or revised legislation and guidelines related to research involving human participants;
• Establish and maintain a risk-driven assessment program consisting of systematic focustracers and (for cause) quality checks related to the conduct of research involving human participants;
• Maintaining the central study registration system (CTMS);
• Optimising processes and infrastructure for the conduct of research involving human participants;
• Providing feedback to the organisation, departments, researchers and the Executive Board on risks and trends identified through quality assurance activities, along with advice on opportunities for improvement;
• Coordinating the assessment and reporting of escalations arising from the conduct of research involving human participants;
• Coordinating and providing support for audits and inspections conducted by external regulatory and accreditation bodies, such as the FDA, JCI, EMA and IGJ;
• Providing overarching support, advice and improvement initiatives related to quality assurance in research involving human participants.

When to contact team Quality Assurance Clinical Research?

• In case of early termination or temporary inclusion/study stop due to quality or safety issues;
• In case regulatory authorities, such as the FDA, EMA or IGJ announced an audit/inspection of a study sponsored by Amsterdam UMC;
• In case you have questions or suggestions for (the agenda of) the Good Research Pratice Committee
• in case you have questions or suggestions for the content of the Research Roadmap (you may also use redactieRR@amsterdamumc.nl)
• For any questions on legislation, regulations, guidelines, policies and internal procedures related to the conduct of research involving human participants.