GCPs definition
GCPs means the then-current standards, practices and procedures promulgated or endorsed by the FDA for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials as set forth in the guidelines titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures in jurisdictions outside the U.S., as they may be updated from time to time, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
GCPs means good clinical practices equivalent to those applicable in the U.S. and specifically including the International Committee on Harmonization Guidelines for Good Clinical Practices.
GCPs means clinical practices in conformity with the current Good Clinical Practices as established by the International Conference on Harmonization, as such regulations may be amended from time to time and in conformity with equivalent regulations in regulatory jurisdictions in the Territory.
More Definitions of GCPs
GCPs means the then-current standards, practices and procedures promulgated or endorsed by the FDA for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials as set forth in the guidelines titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the MHLW and comparable regulatory standards, practices and procedures imposed by any Regulatory Authority in the Territory, as well as guidelines promulgated by the ICH, as the foregoing may be updated from time to time, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
GCPs means the then-current Good Clinical Practice Standards, as defined in the U.S. regulations, 21 CFR, and as further elaborated by the FDA in applicable guidance documents, together with equivalent regulations and requirements in jurisdictions outside of the United States.
GCPs means Georgia Certified Process Server;
GCPs means established ethical, medical and scientific standards, including without limitation good clinical practices, including as described in the ICH Guidelines, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and the Declaration of Helsinki and all applicable regulatory requirements.
GCPs means the then current good clinical practices that establish the national and international ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that are promulgated or endorsed for the United States by the FDA (including through ICH E6 and 21 CFR Parts 50, 54, 56 and 312) and for outside the United States by comparable Governmental Authorities.
GCPs means clinical practices in conformity with the current Good Clinical Practices as established by the International Conference on Harmonization, as such regulations may be interpreted by governing regulatory agencies or as may be amended from time to time, and in conformity with equivalent regulations and interpretations in regulatory jurisdictions in the Territory.
GCPs means the then-current standards, practices and procedures promulgated or endorsed by the FDA or other Regulatory Authorities for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, as set forth in 21 C.F.R. Parts 210 and 211, as may be amended from time to time, or any successor thereto, or in the guidelines titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” and comparable regulatory standards, practices and procedures in jurisdictions outside the U.S., as they may be updated from time to time, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.