Good Research Practice and the Good Research Practice Committee
The Directorate of Quality, Patient Care and Research (DKP) is responsible for overseeing the quality of both clinical and preclinical research at LUMC. The Good Research Practice Committee (cGRP), which operates under DKP, provides solicited and unsolicited advice to the Executive Board and departments on matters of quality assurance related to clinical research.
Good Clinical Practice
Good Clinical Practice is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical studies involving human participants. Compliance ensures public confidence that the rights, safety, and well‑being of research participants are protected and that the data generated are credible and reliable.
Participant safety and research quality are paramount. To safeguard both, LUMC follows the Guideline for Quality Assurance of Research Involving Human Subjects drafted by UMCNL. This guideline describes the minimum quality assurance requirements for research involving human participants within Dutch University Medical Centers. It primarily applies to research under the Medical Research Involving Human Subjects Act (Wet Medisch‑wetenschappelijk Onderzoek met Mensen; WMO).
Research Laboratories
All LUMC research laboratories work according to the GRP/ISO9001 standard of the International Organization for Standardization.
See also the Good Research Practice & Integrity page.
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LUMC’s Quality Framework for Research
LUMC’s quality system for clinical and pre‑clinical research includes:
- Training on laws and regulations for researchers and research support staff
- A quality management system and quality manual for clinical research
- GCP-monitoring of clinical trials by qualified LUMC-monitor team
- Study management system PaNaMa for the registration and oversight of research projects
- A helpdesk for research‑related and SMS PaNaMa questions
LUMC’s quality system for clinical and pre‑clinical research includes:
- Training on laws and regulations for researchers and research support staff
- A quality management system and quality manual for clinical research
- GCP-monitoring of clinical trials by qualified LUMC-monitor team
- Study management system PaNaMa for the registration and oversight of research projects
- A helpdesk for research‑related and SMS PaNaMa questions
- An institution‑wide data management strategy
- A quality management system for pre‑clinical research
- Internal audits, for both clinical and pre‑clinical research by trained LUMC-auditors.
In addition, departmental science committees assess the scientific content of research protocols before submission to official bodies, such as the Ethical Review Board, non-WMO committee and Biobank committee.
The Good Research Practice Committee
The Good Research Practice Committee advises the Executive Board and LUMC departments on enhancing and safeguarding the quality of clinical research. Its advice is based, among other things, on IGJ inspections and GRP/GCP audits. The committee consists of researchers with extensive experience in clinical research and representatives from departments closely involved in clinical research and quality assurance. The committee members can be found on the LUMC intranet page about the Good Research Practice Committee.
Contact
Contact Good Research Practice Committee via email: GRP@lumc.nl