Good Research Practice and the GRP Committee
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting clinical studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible.
The safety of the participants in the research and the quality of the research are paramount. In order to ensure both safety and quality in research involving human subjects LUMC follows the Guideline Quality assurance of research involving human subjects as drafted by the NFU (Nederlandse federatie van Universitair Medische Centra). This guideline defines the minimum requirements that must be met by research involving human subjects in the University Medical Centers. This primarily concerns the quality assurance of research that falls within the scope of the Medical Research Involving Human Subjects Act (Wet Medisch-wetenschappelijk Onderzoek met mensen; WMO).
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- Education about laws and regulations for researchers and research support staff
- A quality manual for clinical research
- Monitoring of clinical trials
- A LUMC broad Data management strategy
- A quality management system for pre-clinical research
- GRP audits, both clinical and pre-clinical
Science committees in every department evaluate the scientific content of research protocols before submission to official authorities such as the Ethical Review Board.
…- Education about laws and regulations for researchers and research support staff
- A quality manual for clinical research
- Monitoring of clinical trials
- A LUMC broad Data management strategy
- A quality management system for pre-clinical research
- GRP audits, both clinical and pre-clinical
Science committees in every department evaluate the scientific content of research protocols before submission to official authorities such as the Ethical Review Board.
Research Education
All clinical investigators at LUMC working on medical-scientific research that falls under the scope of the Medical Research Involving Human Subjects Act (WMO) must obtain the the Basic course on Regulations and Organisation for clinical investigators (Basiscourse Regelgeving en Organisatie voor Klinisch Onderzoekers; BROK®).
Furthermore, research nurses, trial coordinators, and other trial supporting staff have to follow at least a WMO-GCP course (about the Medical Research Involving Human Subjects Act and Good Clinical Practice).
Monitoring
Monitoring is part of a broader quality control system and an essential instrument for the quality assurance of research that is subject to WMO. It serves to verify that the rights and wellbeing of the research subjects are protected, that the study data are reported accurately and are fully verifiable in source documents, and that the conduct of the study is in accordance with the approved protocol/amendment(s), with ICH-GCP and with the relevant legal requirements.
Monitoring at LUMC is carried out by qualified monitors who have an independent role in relation to the study in order to objectively verify the correct conduct and associated documentation of the study. Monitoring is mandatory for all research that falls under the scope of the WMO.
Data Management
Data management is the collection, processing, and validation of research data. LUMC strongly advises using a database for clinical research. It financially supports the use of Castor and working with an Electronic Lab journal.
Research Laboratories
All LUMC research laboratories work according to the GRP/ISO9001 standard of the International Organization for Standardization.
GRP Audits
During a Good Research Practice (GRP) or Good Clinical Practice (GCP) audit, the research process in LUMC’s departments and laboratories is observed by trained auditors. The frame of reference is the Medical Research Involving Human Subjects Act (WMO) and the Good Clinical Practice (ICH-GCP) guidelines. The audits are integrated into the regular audit system at LUMC.
The Good Research Practice Committee
The Good Research Practice (GRP) committee advises the Executive Board on quality assurance of clinical research. The committee consists of researchers with a broad experience in the field of clinical research. LUMC conducts all sorts of research and creates and supports facilities for performing research according to Good Research Practice, more specifically Good Clinical Practice (GCP).
- Prof. Dr. F.A. (Erik) Klok (Chair)
- M.E. Stammen (administrative secretary)
- dr. Dries Braat
- prof. dr. Olaf Dekkers
- prof. dr. Jeroen Eikenboom
- mr. Daniëlle Joosten
- dr. Karin van der Pal-de Bruin
- dr. Nienke van Rein
- dr. Bob Siegerink
- dr. Frank Speetjens
- dr. Monique van Velzen
- prof. dr. Jan Verschuuren
- dr. Margot de Waal
Contact Good Research Practice Committee
Email: GRP@lumc.nl