Research Roadmap

Monitoring

The sponsor (in Dutch verrichter) of the study is responsible for ensuring that the study is adequately monitored. For all investigator initiated studies initiated by Amsterdam UMC that are subject to the Medical Research (Human Subjects) Act (WMO) independent monitoring is provided for by the Executive Board and delegated to the Clinical Monitoring Center.

Monitoring at Amsterdam UMC for investigator initiated studies is free of costs in case of;

• Monocentre studies
• Monitoring at Amsterdam UMC location AMC/VUmc (sponsor site) in case of multicentre studies.

The CMC website provides information about how to request monitoring, as well as on the associated costs in case of participating sites and other types of services and support offered by the CMC.

The intensity and frequency of monitoring take place according to the NFU risk classification and following the agreements made within Amsterdam UMC based on the NFU report Kwaliteitsborging van mensgebonden onderzoek (Quality assurance for research involving human subjects).

Monitoring by members of the research staff of the department conducting the study is not permitted, because independency and quality cannot be guaranteed. In case of external monitoring (e.g. CRO, freelance CRA), the PI has to guarantee that the monitor is qualified and also to ensure that all monitoring activities are performed according to monitoring SOPs.
Please be aware that only on-site monitoring is allowed by external monitors. Here you can find the procedure for requesting an EPIC account for an external monitor.

During the study, monitoring is performed as described in the monitoring plan. For planning purposes, the monitor will periodically touch base with the contact for the study team.The frequency also depends on the number of subjects, the design and risk classification of the study and the results of the previous monitoring visit. The CMC website provides an overview of the preparations that precede a monitoring visit.

Auditing

The Executive Board of Amsterdam UMC has the ultimate responsibility for all research involving human subjects conducted at Amsterdam UMC. She has implemented an internal quality management system according to NFU guideline (2020) and ICH-GCP R2 (2017). As part of that an independent Quality Assurance Clinical Research team is appointed within the department for Care Support, Strategy and Innovation. They are delegated to perform systematic focustracers and sometimes audits on the quality and safety of conducting research involving human subjects in Amsterdam UMC and to advice on points of improvement.

A summary of the tasks of team Quality Assurance Clinical Research:

• Setting up and implementing a risk-driven assessment programme (focustracers/audits)
• Providing feedback to the organization, departments, researchers and the Executive Board with regard to risks & trends in findings and advice on opportunities for improvement
• Coordination the assessment and reporting of escalations arising from conducting research involving human subjects
• Actively monitoring new or revised legislation and guidelines relating to research involving human subjects, and providing information to the organisation
• Develop, maintain and optimise the overall Amsterdam UMC quality policy framework for research involving human subjects
• Providing overarching support, advice and (improvements) initiatives relating to quality assurance in research involving human subjects
• Providing advice and support in case of inspections/accreditations

For questions/advice, please contact teamkwaliteitklinischonderzoek@amsterdamumc.nl