Good Research Practice & Integrity

GRP

Good Research Practice (GRP), including clinical and preclinical research, is performing research in such a way that it fulfills all aspects 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:

  • Advisors 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

Advisors Good Research Practice                    

The advisors for Good Clinical Practice clarifie law and regulations concerning clinical research (e.g. WMO, WGBO, GCP, Code Goed Gedrag en Code Goed Gebruik) for researchers. Furthermore the advisors help researchers completing their research file before sending it to the Ethical Review Board and advice researchers to execute their clinical study according quality assurance. The advisors GRP are 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.

Data Management

Data management is the collection, processing and validation of research data. The LUMC strongly emphasis to use a database for clinical research and financially supports the use of Castor. 

Development of a quality manual for preclinical research

Under construction. 

Basiscursus Regelgeving en Organisatie voor Klinisch 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 before starting their clinical research. Furthermore, research nurses, trial coordinators and other trial supporting staff have to follow at least a WMO-GCP course. GRP organizes different trainings. 

Monitoring

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). In the LUMC all Clinical Trials Involving Human Subjects Act (WMO) of which LUMC is sponsor, will be monitored by LUMC monitors. After approval of the protocol by the CME, monitoring will be discussed with the monitor coordinator of the LUMC.  

GRP Audits

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.  After the audit a report 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.