What is Indian GCP?
INTRODUCTION Good clinical practice (GCP) is an international ethical & scientific quality standard for designing, conducting , recording & reporting trials that involve the participation of human subjects.
What is ICH and GCP?
ICH-GCP. The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
What are the 3 main principles of GCP?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.
Which chapter of ICH GCP is essential documents listed?
At the core of these are the essential documents, as defined by ICH Guideline for Good Clinical Practice, E6, Section 8, “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.”
What is the purpose of ICH?
The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.
What is GCP Slideshare?
Good Clinical Practice (GCP) • An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human beings, Public assurance that the rights, safety, and well being of trial subjects are protected • Results in credible data • …
How did GCP come about?
The development of GCP began at the end of WW2 following the Nuremberg Trials. During these trials Nazi Doctor’s were prosecuted for performing inhumane experiments on human beings in the name of medical science.