Clinical Research Bureau

Mission

The CRB's mission is to support clinical investigators at every step of conducting a clinical trial, from Start-up and execution to closure. 

  

The CRB does this by providing qualitative services that ensure study success and patient safety while maintaining, protecting, and promoting the reputation of the investigators and the department. 

  

The CRB team comprises a coordinator, a Project Team and a Clinical Research team. 

  

CRB Project Team 

The Project Team (PT) provides assistance to clinical investigators in establishing, implementing, and conducting clinical trials. 

The PT consists of certified Project Managers who specialize in the Start-up of (inter)national investigator-initiated and industry-initiated clinical trials. Furthermore, the PT supports data management and maintenance of ongoing studies. 

The PT has a vast knowledge of relevant (inter)national legislation pertinent to the Start-up and support of clinical studies.  

  

Key responsibilities

Start-up: 

• Protocol development advice, 

• Project cost estimation, 

• Support Ethical Committee and Institutional Review Board submissions, 

• Facilitate budget and contract negotiations, 

• Establish collaborations with internal partners, 

• Stipulate study logistics, 

• Prepare and adapt local informed consent forms, 

• Electronic case record forms (eCRF) development and management, 

• Data validation plan development. 

  

Project Maintenance

• Overall project management, 

• Data management, 

• Support Ethical Committee and Institutional Review Board amendment submissions, 

• Facilitate budget and agreement amendment negotiations. 

  

Over the years, the CRB's PT has built a strong network of key players involved in the Start-up and the execution of clinical studies, which positively influences the Start-up process and progression of clinical trials at the Department of Gastroenterology & Hepatology. 

  

The implementation of standard operation procedures (SOPs) and work instructions in the PT's work processes contribute to their endeavor for ever-increasing quality. 

  

CRB Clinical Research Team 

The CRB Clinical Research Team (CRT) is a team formed by certified Research Nurses and Research Assistants committed to conducting high-quality clinical trials, always considering the study participants' comfort and safety, and working according to the clinical study protocol.  

The CRT's collective knowledge and hands-on experience supporting a vast variety of Gastroenterology and Hepatology related clinical studies is invaluable for successful study execution.  

 

Good work ethics and passion for their work make the CRT the force behind the execution of high-quality clinical studies.  

  

The CRT's main tasks are 

• Support the investigator (or medical specialist) in determining the suitability of potential study participants based on medical history and data. 

• Plan and hold nursing consultations for subjects, 

• Perform observations, measurements and tests.  

• Perform nursing medical procedures according to the study protocol, 

• Determine and organize the study-specific logistics processes, 

• Collect information/data/materials for research, 

• Collect and processes human tissue (in the laboratory), 

• Site-Investigator support. 

 

The CRT has access to the facilities of the Gastroenterology and Hepatology department's outpatient clinic, where they perform clinical protocol visits. 

Working in the outpatient clinic results in an optimal collaboration with the clinical investigator and satisfaction among the study participants thereby contributing to a reliable, qualitatively high data collection. 

  

Contact information

The CRB's home base is located at the Erasmus MC's Gastroenterology & Hepatology department. This promotes close collaboration between the Project Team, the Clinical Research Team and the clinical investigators, enabling optimal quality of clinical trial conduct, both in terms of patient safety and the generation of qualitative and reliable data. 

 

The CRB coordinator completes organizational and management tasks in support of the members of the PT and the CRT in the execution of their clinical study endeavors.  

 

The coordinator is the primary contact for inquiries regarding the CRB, projects, and possible collaborations. 

 

Contact the CRB at: 

e-mail address: m.vanlangen@erasmusmc.nl