43 Courses

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.

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.

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.

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.

This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 17 Points Development Level Develop

Data science is quickly taking over all aspects of life, and a huge impact of this can be seen in the healthcare department. From medical imaging to genomics, we now leverage data to make better medical decisions. In this course, we will see how clinical trial data can be effectively managed using SAS.

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.

Reasons to attendDo you want to refresh and improve your CRA skills? Do you need some inspiration to boost your clinical trial monitoring techniques and approach? This CRA Training provides for experienced monitors the knowledge and advanced skills to deal with more complex clinical trials and site management issues. This training, supported by eLearning, provides the best outcome allowing you to learn at your own pace. Increase your odds of becoming a senior CRA with this training. 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

Dive into the dynamic realm of clinical data analysis with our comprehensive Clinical Data Analysis with SAS course. This course is your passport to the pharmaceutical industry, guiding you through the essential components, phases of clinical trials, and types of data crucial in this field. You'll gain proficiency in interpreting clinical study documents, from protocols to ethical consent, enabling you to navigate the intricate world of clinical data. Our course equips you with SAS programming skills, empowering you to develop clinical study reports, analyze demographic data, and derive valuable insights. Whether you're a budding data analyst or a professional aiming to enhance your clinical data expertise, this course provides the knowledge and skills needed for a successful career in clinical data analysis. Learning Outcomes Understand the key components and phases of the pharmaceutical industry. Navigate clinical trials with insights into data types and reports. Interpret clinical study documents, including protocols and ethical consent. Develop clinical study reports using SAS programming. Analyze demographic data and derive valuable insights. Why choose this Clinical Data Analysis with SAS course? Unlimited access to the course for a lifetime. Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course. Structured lesson planning in line with industry standards. Immerse yourself in innovative and captivating course materials and activities. Assessments designed to evaluate advanced cognitive abilities and skill proficiency. Flexibility to complete the Course at your own pace, on your own schedule. Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience. Unlock career resources for CV improvement, interview readiness, and job success. Who is this Clinical Data Analysis with SAS course for? Aspiring clinical data analysts seeking to enter the pharmaceutical industry. Professionals in healthcare, research, or data analysis looking to enhance their clinical data expertise. Students and individuals interested in clinical data and its analysis. Those who want to decode clinical study documents and reports. Anyone aiming to unlock the world of clinical data analysis with SAS. Career path Clinical Data Analyst: £25,000 - £50,000 Biostatistician: £30,000 - £70,000 Pharmaceutical Researcher: £25,000 - £60,000 Data Scientist in Healthcare: £30,000 - £70,000 Clinical SAS Programmer: £28,000 - £60,000 Clinical Research Manager: £35,000 - £80,000 Prerequisites This Clinical Data Analysis with SAS does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Clinical Data Analysis with SAS was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Certification After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8. Course Curriculum Course Promo Course Promo 00:01:00 Section 01: Introduction 1.1 Components of the Pharma Industry 00:05:00 1.2 Phases of Clinical Trials 00:06:00 1.3 Data and Reports in Clinical Trials 00:04:00 1.4 Types of Data 00:05:00 Section 02: Knowledge on Clinical Study Documents 2.1 Clinical Study Protocol 00:02:00 2.2 Ethical Consent 00:01:00 2.3 Inclusion-Exclusion Criteria 00:01:00 2.4 Statistical Analysis Plan: SAP, Mockshell and CRF 00:04:00 Section 03: Developing the Clinical Study Reports 3.1 General SAS Programming Steps 00:02:00 3.2 One Search Report: Demographics Table 00:04:00 3.3 Understanding the Demographics Table 00:03:00 3.4 Programming the Demographics Table 00:05:00 3.5 Importing Raw Demographic Data into the SAS 00:04:00 3.6 Deciding what Procedure to Use 00:02:00 3.7 Deriving the AGE variable 00:10:00 3.8 Obtaining Summary Statistics for AGE 00:04:00 3.9 Adding the 3rd Treatment Group using Explicit Output 00:05:00 3.10 Deriving the SEX variable 00:03:00 3.11 Obtaining Summary Statistics for SEX 00:03:00 3.12 Concatenating the COUNT and PERCENT Variables 00:03:00 3.13 Deriving the RACE Variable 00:03:00 3.14 Obtaining Summary Statistics for RACE 00:03:00 3.15 Stacking All the 3 Summary Statistics Together 00:06:00 3.16 Fixing the Precision Points 00:04:00 3.17 Transposing Data 00:03:00 3.18 Fixing the Order of Statistical Parameters 00:05:00 3.19 Building the Final Report 00:02:00 3.20 Putting the Final Touches to the Report 00:11:00 Resources Resources - Clinical Data Analysis with SAS 00:00:00 Assignment Assignment - Clinical Data Analysis with SAS 00:00:00