The GCP unit at Copenhagen University Hospital was established in 2003, and currently has 16 employees. It is a public contract research organization that offers researchers from ‘the Capital Region, Region Zealand and the Faculty of Health Science at the University of Copenhagen, the necessary quality assurance and quality control systems, needed to ensure that clinical drug research is performed according to the principles of GCP. The GCP unit offers the researcher free of charge assistance, including monitoring, in small trials. In trials of a more elaborative kind, the unit works on a cost coverage basis. Researchers not affiliated with the above mentioned institutions are also welcome to use the services provided by the GCP unit.

 

About GCP
Good Clinical Practice (GCP) is a set of ethical and scientific quality requirements for conducting clinical trials on medicinal products for human use (EMEA 1997). In 2001 the European Parliament approved a directive (Directive 2001/20/EC 2001), which intended to harmonize principles forconducting clinical trials and protecting trial participants, by making compliance with GCP, law in the European Union. As a consequence of adopting this directive, all trials on medicinal products for human use initiated since May 2004 are to be conducted according to the principles of GCP. This also includes trials involving medicinal products that are already registered on the market (phase IV). The only exemption from this requirement is the non-interventional trials, where the medicinal product is prescribed according to the marketing authorization, and where the assignment of a patient to the treatment is not decided in advance by a trial protocol.

 

GCP and public research
Many clinical trials with registered medicinal products are initiated and conducted by independent academic researchers from the hospitals and the universities. A researcher who both initiates and conducts a clinical trial is called a sponsor-investigator, and will therefore have obligations concerning both those of a sponsor and of an investigator. These obligations include the following responsibilities; to implement a quality assurance system with standard operating procedures (SOP’s) and audits in addition to a quality control system which ensures that trials are conducted and data are documented, in compliance with the trial protocol, and principles of GCP. As part of the quality control system, a monitor should closely follow the progress of a trial.

 

Our service
The service offered by the GCP unit at Copenhagen University Hospital includes discussion of the trial protocol and guidance in preparing the written information for trial subjects, or more specifically, the documents for recording data (case report forms, CRF’s), and notification papers. When the trial has been initiated, a monitor from the GCP unit will follow the progress of the trial in order to secure, that the study is conducted in accordance with the protocol, legal requirements and the principles of GCP. Briefly the monitoring of a study includes checking and verification of formalities and written agreements, source data verification, checking of drug accountability and registration of adverse events, surveillance of data handling procedures, and correct archiving. The GCP unit is part of a national network, that in total consists of three GCP units, one in Copenhagen, one in Odense and one in Århus. The GCP units functions in close co-operation with regards to the preparation of standard operating procedures, monitoring of multicentre trials and educational programmes for clinical researchers.

 

Extra services
The GCP-unit offers to undertake some of the sponsors tasks for a fee. By hiring us you will not only save time in the preparation phase of the trial, but also during the trial, as a thouroughly planned set up will reduce the time spent by both the investigator, the study nurse and the monitor.

We offer our expertise within the following benefits:

 

• Preparation of the Case Report Forms(CRF's)
• Establishment of a programme for the electroninc data management
• Preparation of randomization list and code envelopes
• Coordination of Nordic studies(Sweden, Norway, Finland and Iceland)
• Audit of trials