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History and Principles of ICH GCP Pavan Suntharasamai Faculty of Tropical Medicine Marisol University Do Clinical Research? Satisfaction of answering important questions which will improve the health
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ICH GCP stands for International Conference on Harmonisation Good Clinical Practice. It is a set of guidelines that provide a unified standard for the design, conduct, monitoring, auditing, recording, analysis, and reporting of clinical trials.
Sponsors, investigators, and ethics committees are required to adhere to the principles of ICH GCP when conducting clinical trials.
The principles of ICH GCP can be filled out by following the guidelines provided in the ICH E6(R2) document.
The purpose of the principles of ICH GCP is to ensure the protection of the rights, safety, and well-being of clinical trial subjects, and to ensure the credibility of the data generated from the trials.
The principles of ICH GCP require the reporting of all relevant information related to the conduct of a clinical trial, including informed consent, adverse events, protocol deviations, and data integrity.
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