GCP Guideline Clause Samples

The GCP Guideline clause establishes that all parties involved in a clinical trial must adhere to Good Clinical Practice (GCP) standards, which are internationally recognized ethical and scientific quality requirements for designing, conducting, recording, and reporting trials involving human subjects. In practice, this means that sponsors, investigators, and study staff must follow protocols that ensure participant safety, data integrity, and regulatory compliance, such as maintaining accurate records and obtaining informed consent. The core function of this clause is to ensure that clinical trials are conducted ethically and reliably, thereby protecting participants and supporting the credibility of trial results.
GCP Guideline the International Conference on Harmonization E6 Guideline on Good Clinical Practice as set out in the latest version of CPMP/ICH/135/95. (h) zásady SKP: Pokyn Mezinárodní konference pro harmonizaci E6 o správné klinické praxi v poslední verzi CPMP/ICH/135/95.
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