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GCP definition

GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.
GCP means the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. In the United States, GCP shall be based on Good Clinical Practices established through FDA guidances (including ICH E6).
GCP or “Good Clinical Practices” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

Examples of GCP in a sentence

  • The PI must maintain and review study documents as specified by the regulatory authorities and in GCP.

  • Please note, this guidance follows GCP guidelines for maintenance of essential documents.

  • Zkoušející bude provádět Studii v souladu s: (i) všeobecně akceptovanými standardy správné klinické praxe (GCP), (ii) etickým jednáním a způsobem, který přiměřeně chrání bezpečnost, jistotu a pohodu subjektů Studie a údajů získaných ze Studie, (iii) Protokolem, (iv) FDA formulářem 1572, a (v) všemi příslušnými zákony, předpisy a směrnicemi včetně mimo jiné předpisů upravujících provádění Studie, zejména na základě zákona č.

  • The Parties consider it acceptable to prepare the documents referred to in this section in electronic form, in accordance with the requirements arising from these GCP, by persons authorized in the Order and responsible for the proper performance of the Contract.

  • Essential Documents: documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced Good Clinical Practice (GCP): an international ethical and scientific quality standard for designing, conducting, recording and reporting research studies that involve the participation of human subjects.


More Definitions of GCP

GCP means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of Europe and other organizations and governmental authorities in countries for which the applicable Licensed Agent or Product is intended to be Developed, to the extent such standards are not less stringent than United States standards.
GCP means the then current good clinical practices as defined in U.S. Regulations 21 C.F.R. §§ 50, 54, 56, 312 and 314, the International Conference of Harmonization (ICH) E6 “Good Clinical Practice: Consolidated Guidance,” and in any successor regulation or any official guidance documents issued by a Governmental Authority.
GCP means current Good Clinical Practices as specified in the United States Code of Federal Regulations, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.
GCP means the then current “good clinical practices” as such term is defined from time to time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable.
GCP means the General Conditions of Purchase contained in this section.
GCP means the then current standards for clinical trials for pharmaceuticals, as set forth in the United States Federal Food, Drug and Cosmetics Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which the Products are intended to be sold, to the extent such standards are not inconsistent with United States GCP.
GCP means, as to the United States and the European Union, applicable good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union.