Good Clinical Practice Training (GCP): ICH E6(R3)
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Price: $225.00 USD |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Good Clinical Practice Training (GCP): ICH E6(R3)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Training Program: Good Clinical Practice (GCP) Training - ICH E6(R3) Stay ahead in the fast-evolving world of clinical research with our comprehensive GCP Training, fully aligned with the latest ICH E6(R3) revisions. This program is designed for clinical research professionals who want to master the principles, responsibilities, and best practices essential for regulatory compliance and ethical excellence in clinical trials. Through interactive content and real-world case scenarios, you will gain the confidence and knowledge to apply GCP principles effectively across all phases of clinical research - ensuring participant safety, data integrity, and regulatory success. Key topics covered in this course include:
What makes this program unique:
Whether you are an experienced clinical professional seeking to refresh your knowledge or a newcomer aiming to build a strong foundation in GCP, this training ensures you are well-prepared to meet regulatory expectations and uphold the highest standards of clinical research. 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:Instructions Welcome to Good Clinical Practice Training, ICH E6(R3). E6(R3) is the global standard for Good Clinical Practice. Compliance to this standard supports study participant safety, data reliability, and inspection preparedness. Introduction to GCP and GCP Principles This module covers Good Clinical Practice, or GCP, and the GCP Principles. GCP is a recognized standard for clinical trials that provides assurance that trial results are reliable and that the safety of participants are protected. GCP is the foundation for anyone involved in clinical trials. Following GCP support preparedness for regulatory inspections. 45 minutes Essential Records This module covers essential records, which document what occurred during the trial and support the trial results. Well managed essential records ensure the reliability of results and verify compliance with GCP and regulatory standards. During inspections essential records are reviewed to reconstruct and evaluate data reliability and trial participant protections. 15 minutes Investigator Responsibilities This module covers the clinical investigators? responsibilities according to ICH E6(R3). The investigator is responsible for overseeing the conduct of the trial at the clinical site as well as delegating tasks to and overseeing other site staff. The sponsor selects well qualified investigators and monitors the trial at the site to ensure GCP is being followed. To be inspection ready, the investigator, their team and vendors should follow GCP. 17 minutes Sponsor Responsibilities This module covers sponsor responsibilities according to ICH E6(R3). Sponsors are the entity that initiates and funds the trial. They are responsible for the overall quality of the trial. Their most important responsibility is the oversight of the management of the trial. This includes making sure the trial is conducted per the requirements in the protocol. The protocol is the document that describes how to complete the trial, as well as GCP and applicable regulatory requirements. This is needed to ensure the safety of the participants and the trial results. To be inspection ready, the sponsor, their team and vendors must follow GCP. 26 minutes Ethics Committees and Informed Consent This module covers the independent ethics committee, which is otherwise known as the institutional review board, or IRB. Ethics committees are responsible for ensuring a trial follows GCP and the trial design protects study participants. To be inspection ready, the ethics committee must follow GCP. This module also covers the informed consent form and process. Informed consent provides a trial participant with information they need about a trial, including the risks and benefits of the proposed research. 20 minutes Good Documentation Practices This module covers ALCOA+ and good documentation practices. Following these practices help to ensure that data are reliable and trustworthy so that when they are used to support a regulatory application, the regulatory authority has confidence in the results. 23 minutes Data Governance and Computerized Systems This module covers data governance, computerized systems, and electronic records. The guidance includes appropriate management of electronic systems and sources of data, including computer system validation, data integrity, and data security. The responsibilities for electronic systems cross into all the stakeholders discussed in the GCP guideline. 17 minutes Scenarios Now that the lecture portion of the course is complete, it is time to apply your knowledge with real-life case scenarios. Feel free to return to the previous parts of the course to review content to help you answer the questions. They are not graded, but the correct answers will be covered after you have the chance to answer them. 15 minutes | Objectives:Who will benefit from this module? The course is designed for clinical research professionals, including sponsor and CRO personnel, investigators and site staff, or others involved in GCP activities. Learning Objectives - Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6(R3) - Discover how the changes in the guideline affect organizational processes and stakeholder roles and responsibilities. - Identify practical applications of the guideline in your work processes. Course Length: 3.5 hours divided into 8 modules | |
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Benefits of Training with Biopharma Institute
| Immediate Course Access: | Login details, instructions, and payment confirmation are emailed immediately upon online enrollment. |
| Self-Paced eLearning: | Enjoy 24/7 access to all course materials and assessments for 12 months. |
| Open Enrollment: | No prerequisites or prior work experience required to start. |
| Expert-Developed Content: | Courses are designed by subject matter experts (SMEs) in their respective fields. |
| Up-to-Date & Validated: | Training is regularly updated to meet current regulations and is third-party validated or accredited. |
| Optimized for Learning: | Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention. |
| Secure Access: | Encrypted connections, firewalls, and daily malware scans ensure security and system performance. |
| Flexible Assessments: | Multiple-choice exams can be retaken until a passing score is achieved. |
| Instant Certificates: | Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification. |
| Training Verification: | Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications. |
| Manager Access: | A secure portal allows managers to view and download enrollment reports, training records, account balances, and more. |
| SCORM-Compliant: | Courses can be integrated directly into most corporate Learning Management Systems (LMS). |
| Purchase Orders: | We accept POs from all companies. Request an invoice to start the procurement process. |
| Employer Reimbursement: | Some employers may cover training costs -check your company's reimbursement policy. |
| Financial Assistance: | Payment plans are available for eligible learners, or purchase courses individually as needed. |
| Career Advancement: | Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills. |
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