Research Roadmap

Monitoring (quality control)

Monitoring is an essential instrument for the quality assurance of research subject to the Medical Research Human Research Act (WMO). It serves to verify that the research subjects’ rights and well-being are protected, that the study data are recorded accurately and fully verifiably in source documents, and that the conduct of the study is in accordance with the approved protocol (including amendments) and the relevant legal requirements.

Amsterdam UMC demands monitoring for all research subject to the WMO following the NFU 'Guideline Quality Assurance Research involving Human Subjects'. The sponsor (in Dutch verrichter) of a clinical study is responsible for ensuring that the study is adequately monitored.

Monitoring activities should be carried out by qualified monitors. It is important that the monitor is not involved in the conduct of the research (i.e. independent party), as they must be able to objectively verify the proper conduct and associated documentation of the research.

> Monitoring by the Clinical Monitoring Center

For all investigator initiated studies initiated by Amsterdam UMC that are subject to the WMO independent monitoring is provided for* by the Executive Board and delegated to the Clinical Monitoring Center. 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.

During the study, monitoring is performed as described in the monitoring plan. 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 activities carried out by the Clinical Monitoring Center on behalf of Amsterdam UMC sposored trials are financially compensated by the Executive Board and the PI will not be charged. Monitoring activities in service of external research sites are the responsibility of the PI. For an indication of the costs per type of study, risk classification en duration of a trial you can use this calculation tool.

> External monitoring

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 a monitoring plan and monitoring SOPs. Please be aware that due to privacy and safety ploicies remote monitoring is not allowed. Here you can find the procedure for requesting an EPIC account for an external monitor.

Auditing (quality assurance)

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 develop and maintain the overall policy framework for research involving human subjects, perform systematic focustracers and quality checks on compliance in conducting research involving human subjects in Amsterdam UMC and 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 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