129 Courses in Cardiff delivered Online

New drug development requires major investment in capital, human resources and technical expertise. Strict adherence to regulations on testing and manufacturing standards is also required before a new drug can be marketed. One of the greatest challenges in conducting clinical trials is that of efficiency. As trials become more comprehensive, involving large numbers of participants globally, their duration is prolonged and costs increase. The longer trials last, the shorter is the patent life remaining after market approval and the longer patients must wait for the new product. This short course covers the key components of clinical trials and how these requirements interact with the drug development cycle.

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.

A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.

Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

The demands on quality from clinical trials are increasing. Quantitative aspects of clinical trials, such as the mass of study data to be collected, the multiple investigational sites, and the need to meet predetermined timelines, often supersede qualitative features. Therefore, addressing basic requirements for quality management is essential when preparing a clinical trial. This short course describes the core elements required for the establishment of a clinical trial and provides an overview of the role of the sponsor in supporting and improving trial quality.

In clinical trials, endpoints are measurements to evaluate the results of a new treatment, at an individual patient level. The study data can be extrapolated to patient populations on the basis of clinical similarities to patients participating in the trial. When clinical trial data have been obtained, focus is on the trial endpoints; more specifically, the focus is on whether the trial met or failed the primary endpoint specified before the trial started. The purpose and various types of endpoints are discussed in this short course.

Clinical trial protocols are an essential part of clinical trial design. Protocol documents are critical to conducting safe and cost-effective investigations. Protocol documents are large and complex, containing comprehensive information relating to purpose, design and conduct of a clinical trial. Aspects of a protocol include patient eligibility criteria, and treatment specifications. This short course provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.

Clinical trial design establishes the framework upon which the clinical trial process will be conducted, and sets the objectives of the trial. The application for marketing approval, submitted to the regulatory authorities, will provide clinical data reflecting the trial design. Since trial design impacts the whole drug development process and lifecycle, particular care and due diligence is essential. This short course provides an overview of the main types of study design.

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.