Good clinical practice fda regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs human and animal biological . Get this from a library good practice of clinical drug trials alain spriet therese dupin spriet this new edition of good practice is a totally revised and expanded version of this work it takes into account the new quality guidelines in particular those listed in the european union . Good clinical practice gcp is an international quality standard for conducting clinical trials that is provided by ich an international body that defines a set of standards which governments can then transpose into regulations for clinical trials involving human subjectsa similar guideline for clinical trials of medical devices is the international standard iso 14155 which is valid in . Good clinical practice gcp is an international ethical and scientific quality standard for designing recording and reporting trials that involve the participation of human subjects compliance with this standard provides public assurance that the rights safety and wellbeing of trial subjects are
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