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Guidelines for good clinical practice (GCP) for trials on ...

World Health OrganizationWHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials onpharmaceutical products*INTRODUCTIONG lossary AND PREREQUISITES FOR A clinical for the data for the investigational and site(s) of requirements PROTOCOL OF TRIAL of committee OF THE care of trial of trial with the for subjects and informed investigational trial of the trial or submission to the drug regulatory by an ethics adverse events or , auditing and and handling of of and accountability for pharmaceutical products for of in which the investigator is the sponsor OF THE of the Investigator(s) of responsibilities with the protocol and Product Safety management and handling of operating for subjects and of adverse of trial OF THE of the trial education and of the trial or submission to the regulatory OF and recording adverse adverse events AND HANDLING OF of the of the sponsor and the of data AND and OF AND ACCOUNTABILITY FOR PHARMACEUTIC

INTRODUCTION The purpose of these WHO Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products is to set globally applicable standards for the conduct of such

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