GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)
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Price: $95.00 USD |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Updated to ICH GCP E6(R3), this course teaches the critical role of rigorous documentation in proving compliance and ensuring trial integrity. With regulators following the maxim "If it isn't documented, it didn't happen," strong record-keeping is non-negotiable.
Equip yourself with the knowledge to produce audit-ready, regulator-approved documentation every time. Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:Course overview: Sets out the scope, objectives and notes on terminology. - Documentation: Identifies the documents designated by ICH GCP as essential to the conduct of a clinical trial. - Describes important examples. - Outlines how records should be maintained. - Final Assessment. - Certificate of Completion. | Objectives:Who will benefit from this course? This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials. Learning objectives: - Identify essential records for a clinical trial - Outline the contents of an investigator's brochure - Outline the contents of a trial protocol - Give examples of source records and data acquisition tools - Identify trial aspects that are subject to data governance expectations | |
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