JGCP Audit Requirements
1 -Per Article 2, Audit is defined as “an investigation conducted by a sponsor or postmarketing sponsor, or one that a sponsor-investigator appoints a designated personto determine whether the clinical trial or postmarketing clinical trial is conducted according to this Ministerial Ordinance (No. 36) and the protocol or postmarketing protocolto ensure the reliability of the Read more about JGCP Audit Requirements[…]