A Local Ethics Committee has been established at Convex Clinical Research
Center. Its members helps facilitate a rapid study start-up. The committee
operates in accordance with Standard Operating Procedures approved by the
regulatory authorities in Bulgaria. The Ehics Committee aims at
preserving the rights of patients and volunteers, as well as at ensuring their
health and well-being during and after the completion of a clinical trial.
Therefore, the Committee members review all available documentation
regarding a clinical trial prior to its start. They also monitor the ongoing
clinical trial in details and ensure the subjects’ physical and mental integrity.
The Committee holds its meetings twice a month and consit of the following