Good Research Practice (GRP), including clinical and preclinical research, is performing research in such a way that it fulfills all aspect of clean and integer research. Respect for patients, volunteers and animals being subject of scientific research and objectivity and honesty in reporting research results are the main pillars.
The committee GRP, comprising researchers with a broad experience in the field, representing all sorts of (clinical) research, initiates and supports facilities for performing research according to GRP.
This has resulted among others:
- Advisor Good Research Practice
- Committee of science for every department
- Data management strategy
- Development of a quality manual for preclinical research
- Basiscursus Regelgeving en Organisatie voor klinisch Onderzoekers (BROK)
- Monitoring course
- GRP audits
Advisor Good Research Practice
The advisor for Good Clinical Practice clarifies law and regulations concerning clinical research (e.g. WMO, WGBO, GCP, Code Goed Gedrag en Code Goed Gebruik) for researchers. Furthermore the advisor helps researchers completing their research file before sending it to the Ethical Review Board and advices researchers to execute their clinical study according quality assurance. The Advisor GRP is also contact person for the committee GRP.
Committee of Science for every department
Every department performing research has its own committee of science. These committees evaluate the scientific content of research protocols before the department is sending it to official authorities, e.g. Ethical Review Board and Funding programs. Furthermore these committees evaluate the participation of the department in other research programs. For these committees of science a protocol and proposal for regulation was developed.
- Reglement wetenschapscommissie (model voor afdeling) (iProva, document only visible for LUMC parties involved)
- Procedure instellen afdelingsgebonden wetenschapscommissie (iProva, document only visible for LUMC parties involved)
Data management is the collection, processing and validation of research data. ProMISe (Project Manager Internet Server), developed by the section Advanced Data Management (ADM) of the LUMC, fulfills all criteria mandatory for data management in (clinical) research. The ProMISe system provides in custom made databases for scientific medical research as well as an application for online data entry, quality checks and reporting. The LUMC strongly emphasis to use such a database and financially supports the use of ProMISe.
Development of a quality manual for preclinical research
Preclinical research is not as tightly regulated by laws and acts as clinical research. In order to increase the quality assurance of the preclinical research a quality manual and reference framework have been composed. Both documents will be enrolled in the next years.
Basiscursus Regelgeving en Organisatie voor Klinische onderzoekers (BROK)
Since the researchers of (clinical) studies have to follow many regulations in order to execute their research, the NFU developed a course in which the organization of clinical studies is taught. All (principal) investigators of clinical research in the LUMC have to achieve their BROK certificate within 6 month after approval of the medical ethical committee. The LUMC organizes this course 4 times a year.
Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and the applicable regulatory requirement(s). The LUMC offers courses to train research nurses, data managers and trials coordinators for monitoring clinical research with low or moderate risk.
During a GRP audit the process of clinical research is observed at the departments of the LUMC. Frame of reference is the WMO and GCP, accompanied in some internal documents. After the audit a rapport is made of the findings, which will have a follow up by the department. The GRP audits are integrated in the regular audit system of the LUMC.