AGREEMENT SMLOUVA on conducting a clinical study made in compliance with the provision of § 269, paragraph 2, Act No. 513/1991 Coll., Commercial Code, as amended and in compliance with Act No. 378/2007 Coll. on Pharmaceuticals, as amended o provedení...Investigator's Contract • September 20th, 2018
Contract Type FiledSeptember 20th, 2018
AGREEMENT SMLOUVA on conducting a clinical study made in compliance with the provision of § 269, paragraph 2, Act No. 513/1991 Coll., Commercial Code, as amended and in compliance with Act No. 378/2007 Coll. on Pharmaceuticals, as amended o provedení...Investigator's Contract • September 10th, 2018
Contract Type FiledSeptember 10th, 2018informed consent forms (as well as any amendment thereto) from a properly constituted Institutional Review Board/Independent Ethics Committee (hereinafter “IRB/IEC”) prior to the commencement of the Study as well as throughout the duration thereof. Such approval must indicate the date it was given, the name and signature of the Chairman or Secretary of the IRB/IEC as well as the names and professions/positions of the members of the IRB/IEC. od řádně ustavené Etické komise zdravotnického zařízení/nezávislé Etické komise. Tento souhlas musí obsahovat datum jeho vydání, jméno a podpis předsedy nebo tajemníka Etické komise zdravotnického zařízení/nezávislé Etické komise a jména a profese/funkce členů Etické komise zdravotnického zařízení/nezávislé Etické komise. 3.4. INVESTIGATOR will obtain written informed consent from each patient enrolling in the Study prior to the commencement of any Study procedure. The method of explanation to the patient and the obtaining of their consent has to c