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JANUARY 22-24, 2000 Amman Marriott Hotel Islam Alumni Street Amman, JORDAN N FFE RI FIRST O F G Training ! Of this an in Word shop To INTRODUCTION TO GOOD CLINICAL PRACTICES AND AUDITING In Cooperation
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Introduction to good clinical is a document that outlines the key principles and standards for conducting clinical trials in accordance with good clinical practice (GCP) guidelines.
Sponsors or organizations conducting clinical trials are generally required to file the introduction to good clinical as part of the trial documentation.
The introduction to good clinical can be filled out by providing information on the purpose of the trial, the study design, the inclusion and exclusion criteria for participants, and other essential details. It should also adhere to the specific regulatory requirements of the relevant jurisdiction.
The purpose of the introduction to good clinical is to ensure that clinical trials are conducted ethically, with integrity, and in compliance with regulatory requirements. It aims to protect the rights, safety, and well-being of trial participants, and to generate reliable data for evaluating the effectiveness and safety of investigational drugs or treatments.
The introduction to good clinical should report key information such as the trial objectives, methodology, anticipated benefits and risks for participants, procedures for data collection and analysis, informed consent process, and details of ethical review and regulatory approvals.
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