Good Clinical Practice (GCP) definition

Good Clinical Practice (GCP) means 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.
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Good Clinical Practice (GCP) means the applicable regulations and guidelines established by or acceptable by the UK regulatory authorities relating to good clinical practice for trials in human beings, including without limitation the CPMP Note for Guidance on Good Clinical Practice (reference CPMP/ICH/135/95), as may be amended or updated from time to time and as such are implemented in the UK.
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Examples of Good Clinical Practice (GCP) in a sentence

  • The ICH Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2).

  • The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2).

  • Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.

  • This study will be conducted in accordance with the International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) and the appropriate regulatory requirements.

  • To describe the procedures to be followed for handling clinical Investigational Medicinal Products (IMP) in order to comply with applicable regulations and guidelines for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

  • It must be set up in compliance with Good Clinical Practice (GCP) standards and applicable local regulatory requirements.

  • The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOP’s), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

  • This study will be conducted in accordance with the International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) (27) and the appropriate regulatory requirements.

  • In this Agreement, unless the context otherwise requires: Adverse Event has the meaning given in the Good Clinical Practice (GCP) guidelines.

  • The TRIAL shall be conducted in accordance with the Principles set out in the Declaration of Helsinki, with the ICH (International Conference on Harmonisation) guidelines for Good Clinical Practice (GCP), as well as with the deontological standards and national and international anti-corruption legislation contained in the OECD Convention adopted on 21 November 1997, and also with the Foreign Corrupt Practices Act (FCPA) which may be applicable to one or all of the parties to this contract.

Related to Good Clinical Practice (GCP)

  • Good Clinical Practice or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines 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 a Licensed Product is intended to be sold to the extent such standards are not less stringent than the ICH guidelines.

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Clinical practice guidelines means a systematically developed statement to assist

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.