Klin Farmakol Farm. 2007;21(3):122-124
Co-operation of the investigator with the sponsor in clinical trials
- PPD Czech Republic s. ,r. ,o., Praha
The investigator plays a key role in clinical trials both in case the trial is conducted by the sponsor – pharmaceutical company, or by a Contract Research Organisation. According to the Good Clinical Practice (GCP) the investigator is the person responsible for the clinical trial on the respective trial site. The physician in a role of an investigator has not only the rigt to conduct the trial, but also many trial related duties. In this article the duties are being described according to the time course of a clinical trial, inlcuding referring to relevant legislation. In the beginning of the co-operation related to a clinical trial the physician proves his qualification and qualification of the site to conduct the trial. During the course of the trial the importance of the contents and quality of the medical records is stressed, as these records are the source of data for future statistical analysis. Strict adherence to the protocol and to GCP and rules of managment of experimental medication is inevitable. On the other hand, a CRO acting as a sponsor, is obliged to monitor the trial. The co-operation of the investigator with the monitor in a case of an audit on the site is also discussed.
Keywords: investigator, contract research organisation, good clinical practice, clinical trials
Published: January 1, 2008 Show citation
References
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