Good Clinical Practice

Good Clinical Practice. A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected as are generally accepted as standard in the industry at Effective Date and as specified by World Medical Association Declaration of Helsinki

Good Clinical Practice. Such practices as are prescribed by the FDA's "Good Clinical Practice Consolidated Guideline."

Good Clinical Practice. Or GCP shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the ethical conduct of clinical trials promulgated or endorsed by a Regulatory Authority of competent jurisdiction, including the relevant regulations set forth in U.S. Code of Federal Regulations (CFR) Title 21, ICH GCP Guidelines E6(R2), current step 5 version, dated 14 June 2017, as amended from time to time, national legislation implementing European Community... Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, European Community Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use and European Community Regulation 2014/536/EU dated 14 April 2014, as amended from time to time. View More