43 Good Clinical Practice (GCP) courses delivered On Demand

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

ABOUT COURSE Understand the Ethical and Regulatory Framework for Conducting Clinical Trials   Course Description This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring you grasp the essential standards for conducting clinical research. Course Objectives By the end of this course, you will be able to: * Articulate the definition, purpose, and historical context of GCP. * Explain the importance of GCP in protecting human subjects and ensuring data integrity. * Identify key international organizations involved in establishing GCP standards. * Apply ethical principles and informed consent procedures in clinical research. * Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice. * Design and conduct clinical trials according to ICH E8 and E9 guidelines. * Manage and report clinical trial data in compliance with ICH E6(R2) guidelines. * Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines. * Navigate regulatory compliance and inspections related to clinical trials. Target Audience This course is designed for individuals who: * Are interested in pursuing a career in clinical research or clinical trial management. * Work in the pharmaceutical, biotechnology, or medical device industry. * Seek to gain a comprehensive understanding of GCP principles and practices. Prerequisites No prior experience in clinical research is required. However, a basic understanding of research methodology and medical terminology is recommended. Please Note: This course is strictly theoretical and does not qualify participants for clinical practice in the industry. Additional training and certifications may be required for hands-on experience. WHAT WILL YOU LEARN? * Articulate the definition, purpose, and historical context of GCP. * Explain the importance of GCP in protecting human subjects and ensuring data integrity. * Identify key international organizations involved in establishing GCP standards. * Apply ethical principles and informed consent procedures in clinical research. * Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice. * Design and conduct clinical trials according to ICH E8 and E9 guidelines. * Manage and report clinical trial data in compliance with ICH E6(R2) guidelines. * Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines. * Navigate regulatory compliance and inspections related to clinical trials. COURSE CONTENT INTRODUCTION TO GOOD CLINICAL PRACTICE (GCP) AND ICH GUIDELINES * INTRODUCTION TO GOOD CLINICAL PRACTICE (GCP) AND ICH GUIDELINES ETHICAL PRINCIPLES, INFORMED CONSENT, AND ICH E6(R2) * ETHICAL PRINCIPLES, INFORMED CONSENT, AND ICH E6(R2) DESIGNING AND CONDUCTING CLINICAL TRIALS WITH ICH E8 AND E9 * DESIGNING AND CONDUCTING CLINICAL TRIALS WITH ICH E8 AND E9 DATA MANAGEMENT AND REPORTING WITH ICH E6(R2) * DATA MANAGEMENT AND REPORTING WITH ICH E6(R2) SAFETY AND MONITORING IN CLINICAL TRIALS WITH ICH E6(R2) AND E6(R3) * SAFETY AND MONITORING IN CLINICAL TRIALS WITH ICH E6(R2) AND E6(R3) REGULATORY COMPLIANCE, INSPECTIONS, AND ICH E6(R3) * REGULATORY COMPLIANCE, INSPECTIONS, AND ICH E6(R3) A course by Xpert Learning RequirementsA basic understanding of research methodology and medical terminology is recommended. Audience Individuals who are interested in pursuing a career in clinical research or clinical trial management. Individuals who work in the pharmaceutical, biotechnology, or medical device industry. Individuals who seek to gain a comprehensive understanding of GCP principles and practices. AUDIENCE * Individuals who are interested in pursuing a career in clinical research or clinical trial management. * Individuals who work in the pharmaceutical, biotechnology, or medical device industry. * Individuals who seek to gain a comprehensive understanding of GCP principles and practices.

GCP Good Clinical Practice

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

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