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
Certification After successfully completing the course, you will be able to get the UK and internationally accepted certificate to share your achievement with potential employers or include it in your CV. The PDF Certificate + Transcript is available at £6.99 (Special Offer - 50% OFF). In addition, you can get a hard copy of your certificate for £12 (Shipping cost inside the UK is free, and outside the UK is £9.99).
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Enthralled by the remnants of the classical era? Passionate about theatre and art or captivated by epic movies and historic battles? Our A-Level Classical Civilisation course offers you an enlightening exploration of the ancient world, studying a diverse blend of classical literature, visual artefacts, and culture. Embark on an in-depth journey into Ancient Greece with this course, engaging with timeless classics like Homer's Odyssey and Virgil's Aeneid. The A-Level Classical Civilisation course unveils insights into vital concepts that shape both ancient and modern societies, from the concept of love to the principles of democracy. Understand the social and historical context linking classical thoughts to the contemporary world. This course is designed to sharpen your evaluative and analytical skills, enabling you to effectively engage with a wide range of source materials. These skills are valuable across numerous higher-level degrees and professional paths. A-levels are revered as the educational benchmark in the UK, acknowledged by universities and employers as a testament to substantial accomplishment. Our home study course aligns with the new OCR A-Level Classical Civilisation syllabus, specifically tailored for online, self-paced learning. With unlimited tutor support, a clear induction, and structured assignments, we guide you to develop the knowledge and skills needed for exam success. If you opt to take your final A-Level examinations in the UK, we guarantee access to one of our exam centres. Perks of this course include: - A freshly designed course, following the latest specification with compelling and interactive content - Fast track option available for 2022 exams - Complimentary e-textbooks to assist your learning - Access to a network of partnered exam centres (guaranteed exam venue) - Limitless tutor support for study planning and throughout the course - Exam pass guarantee (We provide support for your next exam if you don't pass on your first attempt) An A-Level in Classical Civilisation equips you with an intricate understanding of the classical world, derived from studying a variety of ancient literature, thoughts, and culture. About the awarding body Awarding body: OCR Our course code: X921 Qualification code: H408 OCR is a premier UK awarding body, creating qualifications that inspire learners of all ages and abilities. Its broad spectrum of general and vocational qualifications equips learners with the knowledge and skills necessary for their future, supporting them in reaching their full potential. The qualifications are developed in close collaboration with educators, industry professionals, and government to meet the requirements set by the Office of Qualifications and Examinations Regulation (Ofqual). ⏱ Study Hours: Allocate between 250 and 300 hours for study, plus additional time for completing assignments. 👩🏫 Study Method: We utilise our dynamic online learning platform for course delivery. Don't fret; you can print the learning materials if you prefer. The learning resources include videos, quizzes, and interactive activities. 📆 Course Duration: The course runs for up to 24 months from the enrolment date. You'll receive login details to our MyOxbridge portal, where you can access your learning materials. 📝 Assignments Commence your learning journey for Summer 2023 exams. This course demands the completion of three comprehensive A-Level examinations: 📚 Paper 1: Lasting 2 hours and 20 minutes, contributing to 40% of A-Level, with a total of 100 marks. 📚 Paper 2 & 3: Each lasting 1 hour and 45 minutes, contributing to 30% of A-Level each, with 75 marks up for grabs per paper. These examinations comprise a combination of concise and detailed responses and extended answers. We assure a secure exam place in our nationwide centres. Locate your nearest centre today. We proudly offer an exam pass guarantee. Should you not succeed at first attempt, we pledge our complimentary support for your subsequent attempts. 📝 Assignments During your course journey, you'll be tasked with completing several assignments. These won't count towards your final grade but provide an avenue for tutor feedback and grading, assisting you in tracking your progress. This will be crucial for generating predicted grades if necessary. 👩🎓 Course Outcomes Upon successful accomplishment of this home-based learning course, you'll earn an A-Level in Classical Civilisation, conferred by OCR. This qualification is on par with that issued by any other educational institution, be it school, college, or university. We've selected this syllabus as we believe it's best suited to online learning and offers the highest possibility of success. ℹ️ Additional Information Course Difficulty - Level 3 Prerequisites - A strong recommendation for candidates to have pursued English Literature to GCSE or equivalent level prior to embarking on this course. UCAS Points - 56 Course Content ⚔️ The world of the hero Starting off, you'll delve into the depths of Homer’s Odyssey, nurturing a mature understanding of this magnum opus and the spiritual, cultural, and societal norms that it represents. You'll explore the essence of a hero in the Greek realm, scrutinising literary mechanisms and structure that frame the plot, including speech utilisation, portrayal of war, mortality, fate, and relationships. 🎭 Culture and the arts In this module, you'll examine the visual and material culture of the Greek Theatre, underlining the drama's impact on the classical world and its enduring influence on contemporary culture. 🌍 Beliefs and ideas In the concluding unit, you'll investigate the religious facets of ancient Greek society, focusing on the Olympian deities, the relationship between gods and mortals, and Homer and Hesiod's importance in shaping Greek religious perceptions. Subsequently, you'll explore mystery cults and their emphasis on initiation, personal choice, and individual participation. Lastly, you'll discern the interplay between religion and society, politics and religion, alongside the Panathenia and its relevance to Athens.