97 Clinical Research courses

Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance of data integrity in clinical research are required by law and/or established as expectations in regulatory guidance. The data are reviewed in regulatory applications or during regulatory inspections of clinical trial sponsor and investigational sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the organizations or individuals concerned. This course explains the requirements and describes principles and practices that should be followed by trial sponsors, investigators and other clinical research personnel to assure regulators of data integrity.

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.

Enhance your medical writing skills with our Level 3 course. From understanding medical journalism to mastering clinical research writing, this CPD Certified program offers comprehensive training for aspiring medical writers and professionals in the healthcare industry.

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.

Reasons to attendHow to ensure a successful clinical trial within timelines and budget? This Clinical Project Management training is a blended course (eLearning + Classroom or Webinars) designed to introduce the ins and outs of managing clinical research projects. The clinical study setting allows you to implement this knowledge immediately within your research projects.What's included? Documents and materials related to this course are included Globally recognised certificates awarded after test completion This course has been granted PharmaTrain Recognition

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.

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.

Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.

Designed for aspiring medical writers, this comprehensive Medical Writing and Social Justice: The Intersection course has many critical modules, from the fundamentals of medical writing to the impact of journalism and mass media. By delving into the intersection of medicine and social justice, this Medical Writing course promises to equip you with the knowledge necessary to craft compelling narratives, influence public opinion, and advocate for a healthier, more equitable world. Join us today and learn how to use written words to drive meaningful change. Learning Outcomes: Develop proficiency in medical writing, effectively communicating complex medical concepts to diverse audiences. Understand the crucial role of medical writers in promoting social justice and advocating for equitable healthcare. Gain expertise in crafting compelling reviews, reports, and journalistic pieces on medical topics. Acquire knowledge of the ethical considerations and guidelines in medical writing, ensuring accuracy and integrity. Learn to collaborate with medical professionals and contribute to the dissemination of critical research. Explore the realm of clinical research, mastering the art of writing in this specialised field. In the realm of medicine, the power of the written word is undeniable. Welcome to a course that converges the art of medical writing with the urgency of social justice. Dive into an illuminating journey where Medical Writing and Social Justice merge the realms of healthcare communication and advocacy. This theoretical course, carefully crafted to expand your understanding, takes you through a series of captivating modules that unravel the profound impact of writing in the medical domain. Delve into the essentials of medical writing, mastering the art of conveying complex concepts with clarity and precision. Explore the symbiotic relationship between medical journalism and mass media, and discover how words can shape public perception, foster inclusivity, and drive meaningful change. As you progress, you'll gain valuable insights into the role of medical writers in clinical research, navigating the intricacies of this specialised field with finesse. Designed for aspiring medical writers, researchers, and healthcare professionals, this Medical Writing course is your passport to honing your written communication skills while championing social justice. By the end of the Medical Writing and Social Justice program, you'll be equipped to craft powerful narratives, influence public opinion, and advocate for a healthier, more equitable world. Join us on this transformative journey where the written word meets social change. Enrol today! Certification Upon completion of the course, learners can obtain a certificate as proof of their achievement. You can receive a £4.99 PDF Certificate sent via email, a £9.99 Printed Hardcopy Certificate for delivery in the UK, or a £19.99 Printed Hardcopy Certificate for international delivery. Each option depends on individual preferences and locations. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This course is particularly useful for: Aspiring medical writers seeking to enhance their written communication skills Healthcare professionals interested in advocating for social justice through their writing Researchers aiming to effectively communicate their findings to a wider audience Individuals passionate about the intersection of medicine and social change Career path This Medical Writing course will be helpful for anyone looking to pursue a career as: Medical Writer: £30,000 to £50,000 per year Medical Journalist: £25,000 to £45,000 per year Clinical Research Writer: £35,000 to £60,000 per year Healthcare Communications Specialist: £35,000 to £55,000 per year Pharmaceutical Copywriter: £30,000 to £50,000 per year Medical Editor: £30,000 to £50,000 per year