Abstract
The European Community Directive for good clinical practice (GCP) was introduced as a requirement of the Ministry of Health and Social Welfare in Poland in January 1993. The Central Register of Clinical Trials (CRCT) was established 16 months later. Since then, the CRCT had to be notified of all studies involving patients according to established rules.
New requirements and procedures made the system transparent and it was generally accepted by sponsors. The approval time was shortened from unpredictable to 42 calendar days. Therefore, the number of studies, including multinational ones, increased.
The CRCT was notified about more than 300 clinical trials covering numerous areas of medical research during the covered period of time (23 months). They were organized and supervised by local and foreign companies and contract research organizations.
The quality of local clinical research improved substantially due to additional GCP training and consulting activities. Recently, the attempt to unify ethics committees' requirements and transparency of their work was undertaken. Moreover, in the near future regulatory GCP inspection should be implemented
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