***24 Hour Limited Time Flash Sale*** Clinical Project Manager (CPM) Admission Gifts FREE PDF & Hard Copy Certificate| PDF Transcripts| FREE Student ID| Assessment| Lifetime Access| Enrolment Letter Are you a professional feeling stuck in your career, struggling to keep up with the ever-changing demands of the industry? Or perhaps you're a beginner, unsure of where to start or how to break into your desired field. Whichever stage you're in, our exclusive Clinical Project Manager (CPM) Bundle provides unique insights and tools that can help you achieve your goals. Designed to cater to the needs of both seasoned professionals and aspiring newcomers, our Clinical Project Manager (CPM) bundle is a comprehensive program that will equip you with the essential skills and knowledge you need to succeed. Whether you're looking to advance in your current role or embark on a new career journey, this bundle has everything you need to take your professional life to the next level. 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Courses Are Included In this Clinical Project Manager (CPM) Career Bundle: Course 01: Level 5 Diploma in Leadership and Management for Adult Care Course 02: Project Management Course 03: Agile Project Management Course 04: Diploma in Operations Management Course 05: Medical & Clinical Administration Diploma Course 06: Clinical Governance Level 5 (endorsed by The Quality Licence Scheme) Course 07: Quality Control in Healthcare and Clinical Audit Course 08: Clinical Observations Skills Course 09: Clinical Psychology Course 10: An Introduction to Clinical Anaesthesia Course 11: Diploma in Clinical Coding (CPD Accredited) Course 12: Supervision in Adult Care Course 13: Research in Adult Care Course 14: Introduction to Medical Terminology Course 15: Anatomy and Physiology of the Human Body Course 16: Introduction to Health Economics and Health Technology Assessment Course 17: Initial Training of Community Health Agents Course 18: Medical Terminology: Course 19: Healthcare GDPR Training Course 20: Medical Secretary Diploma Course 21: Medical Receptionist Course Course 22: Medical Law Course 23: Medical Transcription Course 24: Nurse Prescribing Diploma Course 25: Pharmacy Assistant and Technician Foundation Diploma Course 26: Infection Prevention and Immunisation Course 27: Decision-Making in High-Stress Situations Course 28: Public Health Course 29: Effective Communication Course 30: Risk Assessment in Health & Social Care With Clinical Project Manager (CPM), you'll embark on an immersive learning experience that combines interactive lessons with voice-over audio, ensuring that you can learn from anywhere in the world, at your own pace. And with 24/7 tutor support, you'll never feel alone in your journey, whether you're a seasoned professional or a beginner. Don't let this opportunity pass you by. Enrol in Clinical Project Manager (CPM) today and take the first step towards achieving your goals and dreams. Why buy this Clinical Project Manager (CPM)? Free CPD Accredited Certificate upon completion of Clinical Project Manager (CPM) Get a free student ID card with Clinical Project Manager (CPM) Lifetime access to the Clinical Project Manager (CPM) course materials Get instant access to this Clinical Project Manager (CPM) course Learn Clinical Project Manager (CPM) from anywhere in the world 24/7 tutor support with the Clinical Project Manager (CPM) course. Start your learning journey straightaway with our Clinical Project Manager (CPM) Training! Clinical Project Manager (CPM) premium bundle consists of 30 precisely chosen courses on a wide range of topics essential for anyone looking to excel in this field. Each segment of Clinical Project Manager (CPM) is meticulously designed to maximise learning and engagement, blending interactive content and audio-visual modules for a truly immersive experience. Certification You have to complete the assignment given at the end of the Clinical Project Manager (CPM) course. After passing the Clinical Project Manager (CPM) exam You will be entitled to claim a PDF & Hardcopy certificate accredited by CPD Quality standards completely free. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Clinical Project Manager (CPM) course is ideal for: Students seeking mastery in Clinical Project Manager (CPM) Professionals seeking to enhance Clinical Project Manager (CPM) skills Individuals looking for a Clinical Project Manager (CPM)-related career. Anyone passionate about Clinical Project Manager (CPM) Requirements This Clinical Project Manager (CPM) doesn't require prior experience and is suitable for diverse learners. Career path Senior Clinical Project Manager Clinical Operations Director Clinical Research Director Head of Clinical Trials Vice President of Clinical Operations Certificates CPD Accredited Digital certificate Digital certificate - Included CPD Accredited Hard copy certificate Hard copy certificate - Included If you are an international student, you will be required to pay an additional fee of 10 GBP for international delivery, and 4.99 GBP for delivery within the UK, for each certificate
Did you know that in the UK, 1 in 20 hospital admissions experience avoidable harm? Shocking, right? But what if you could play a role in changing that statistic? That's where our clinical governance course comes in. This course will equip you with the knowledge and skills to be a champion for safe, high-quality healthcare. This Diploma in Clinical Governance at QLS Level 5 course is endorsed by the Quality Licence Scheme and accredited by CPDQS (with 150 CPD points) to make your skill development and career progression more accessible than ever! The Clinical Governance course is a comprehensive program for healthcare professionals, offering 11 modules to understand the importance of Clinical Governance in maintaining quality and safety of healthcare services. It covers topics like National Health Services, clinical auditing, workplace safety, legal challenges, and COVID-19 awareness. Effective implementation of Clinical Governance practices has led to reduced mortality rates, fewer adverse events, and higher patient satisfaction. Learning Outcomes of Clinical Governance Course: Develop a profound understanding of Clinical Governance principles and practises. Master the 7 Pillars of Clinical Governance for comprehensive healthcare management. Gain insights into the pivotal role of National Health Services in governance. Enhance clinical effectiveness through evidence-based practise and outcome evaluation. Acquire proficiency in conducting clinical audits to ensure quality assurance. Navigate complex legal and ethical challenges inherent in healthcare environments. UK statistics show that robust Clinical Governance frameworks in healthcare organisations lead to higher patient satisfaction and improved clinical outcomes. This Clinical Governance course provides valuable insights into clinical governance and tools to enhance professional competence. Why Choose Our Clinical Governance Course at QLS Level 5? FREE Clinical Governance at QLS Level 5 certificate Get a free student ID card with Clinical Governance Training Get instant access to this Clinical Governance course. Learn Clinical Governance from anywhere in the world The Clinical Governance is affordable and simple to understand The Clinical Governance is an entirely online, interactive lesson with voiceover audio Lifetime access to the Clinical Governance course materials The Clinical Governance comes with 24/7 tutor support Invest in your career and make a difference in the lives of patients. Enrol Now! Take a step towards a brighter future with our Clinical Governance course! *** Course Curriculum *** Here is the curriculum breakdown for the Clinical Governance at QLS Level 5 course: Module 01: Introduction to Clinical Governance Module 02: The 7 Pillars of Clinical Governance Module 03: National Health Services Module 04: Clinical Effectiveness: Part 1 Module 05: Clinical Effectiveness: Part 2 Module 06: Clinical Audit Module 07: Confidentiality in a Medical Environment Module 08: Information Technology in Health Care Module 09: Legal aspects and Ethics Module 10: Maintaining Workplace Safety Module 11: Covid-19 Awareness Assessment Process of Clinical Governance You have to complete the assignment questions given at the end of the course and score a minimum of 60% to pass each exam. Our expert trainers will assess your assignment and give you feedback after you submit it. You will be entitled to claim a certificate endorsed by the Quality Licence Scheme after you have completed all of the Diploma in Clinical Governance at QLS Level 5 exams. CPD 150 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Clinical Governance at QLS Level 5 course is perfect for highly motivated people who want to improve their technical skills and prepare for the career they want! Also, our Clinical Governance course is perfect for: Healthcare professionals Medical administrators Quality assurance personnel Healthcare managers Clinical auditors Aspiring healthcare leaders Requirements No prior background or expertise is required for this Clinical Governance course. Career path The Clinical Governance at QLS Level 5 course will boost your CV and aims to help you get the job or even the long-awaited promotion of your dreams. Healthcare management Quality assurance Clinical auditing Compliance roles Legal advisory Leadership roles Certificates CPDQS Accredited PDF Certificate Digital certificate - Included Diploma in Clinical Governance at QLS Level 5 Hard copy certificate - Included Show off Your New Skills with a Certificate of Completion After successfully completing the Diploma in Clinical Governance at QLS Level 5, you can order an original hardcopy certificate of achievement endorsed by the Quality Licence Scheme and also you can order CPDQSAccredited Certificate that is recognised all over the UK and also internationally. The certificates will be home-delivered, completely free of cost.
Description Clinical Psychology Diploma Embarking on a journey through the comprehensive Clinical Psychology Diploma online course ensures that enrollees gain profound insights into the enthralling field of clinical psychology, delving deep into an array of aspects that foster a robust understanding and skills to navigate through numerous psychological scenarios encountered in professional practice. This course brilliantly illuminates the path for aspirants, offering crucial knowledge beginning with an 'Introduction to Clinical Psychology'. Through this section, it deftly establishes a robust base, elucidating fundamental concepts and the intrinsic framework which shapes the profession of clinical psychology. It adeptly builds an understanding of the complexities and intriguing aspects embedded in the field, ensuring a solid foundation for the comprehensive learning journey ahead. Through the meticulously structured Clinical Psychology Diploma, learners explore the realm of 'Psychological Assessment Tools', acquiring discerning knowledge about various instruments and methodologies that psychologists utilize to assess, diagnose, and formulate treatment plans. It elucidates the intrinsic details about selecting appropriate tools, ensuring that participants become proficient in choosing and administering psychological assessments in their eventual practice. Moving forward, the course enlightens students about 'Common Psychological Disorders', offering an in-depth examination of various mental health conditions that are frequently encountered in clinical settings. Knowledge about these disorders not only aids in recognition but also enhances the capability to devise informed, strategic interventions in clinical practice. Moreover, in the domain of 'Therapeutic Modalities in Clinical Psychology', the course extends an analytical look at various therapeutic approaches and techniques. It imparts invaluable knowledge about selecting and implementing diverse therapeutic interventions, tailoring strategies to the specific needs and dynamics presented by patients. The 'Clinical Psychologist-Patient Relationship' segment emphasises the critical importance of establishing and maintaining a therapeutic alliance, elaborating on the ethics, boundaries, and effective communication skills essential in forging a constructive and healing relationship within the therapeutic space. Venturing into 'Neuropsychology and Brain-Behaviour Relationships', this online Clinical Psychology Diploma offers an exploration into the fascinating intersection between neurological processes and behavioural patterns. It renders profound insights into how neuropsychological understanding enhances diagnostic and intervention strategies in clinical psychology. The course then pivots towards 'Psychopharmacology in Clinical Practice', enabling students to comprehend the role and applicability of psychotropic medications, acknowledging the integral part these pharmacological interventions often play in comprehensive mental health treatment plans. Exploring 'Clinical Work with Special Populations' provides a magnifying glass through which participants explore and understand the nuanced approaches required when working with diverse populations, considering cultural, demographic, and specific needs to formulate adept and sensitive intervention strategies. Eyeing towards what lies ahead, 'The Future of Clinical Psychology' unit of the course envisages upcoming trends, technological integrations, and evolving practices within the field, ensuring that students remain abreast of the future trajectories that clinical psychology may undertake. Finally, 'Pursuing a Career in Clinical Psychology' moulds the pathway for aspiring psychologists, offering insightful guidance regarding career progression, specialisation, and continual professional development. This section becomes a cornerstone for those envisioning a flourishing career in the field, providing them with the strategic compass to navigate through their professional journey effectively. In conclusion, this intricate and thoroughly curated Clinical Psychology Diploma online course stands as a beacon for those aspiring to delve into the multifaceted world of clinical psychology. It stands apart by not merely being an informational guide but by being a profound, insightful mentor guiding through each intricate layer of clinical psychology practice, ensuring that each participant emerges with not just knowledge, but with a deep-seated understanding and proficient skills to navigate the enthralling world of clinical psychology with finesse and ethical responsibility. What you will learn 1:Introduction to Clinical Psychology 2:Psychological Assessment Tools 3:Common Psychological Disorders 4:Therapeutic Modalities in Clinical Psychology 5:The Clinical Psychologist-Patient Relationship 6:Neuropsychology and Brain-Behaviour Relationships 7:Psychopharmacology in Clinical Practice 8:Clinical Work with Special Populations 9:The Future of Clinical Psychology 10:Pursuing a Career in Clinical Psychology Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.
Learn more about entering the exciting field of Clinical Research, and how you can quickly start or grow your career! Tuesday, August 27 · 1 - 2am GMT+1 Join us to learn about Clinical Research--a growing field that offers a variety of career opportunities--and how you can acquire the skills to work in Clinical Research! Ask questions of experts working in the field. Discover the PCC Clinical Research program. In this 6 month, part-time class, you learn the foundational terms, concepts, and elements of designing and implementing clinical research, preparing you for a great job for an in-demand role. Most positions offer starting hourly rates ranging between $23-$36 per hour, and typically include benefits. Clinical research skills and knowledge are used in research sites such as medical centers and hospitals, pharmaceutical, device or biotechnology companies, or in contract research organizations. PCC's Foundations of Clinical Research curriculum was developed in partnership with local Oregon healthcare leaders including OHSU, Kaiser Permanente, Providence Health & Services, and Legacy Health. In the Foundations of Clinical Research non-credit certificate program at PCC's Institute for Health Professionals, you will learn will ethical, regulatory, historical and operational, recruitment, reporting, and other principles that support successful clinical trials. Seeking a new opportunity in a growing field? Already a CNA or Nurse and looking to transition to a role that doesn't have you running ragged all day? Check out PCC's IHP Clinical Research program!
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.
The comprehensive Clinical Data Analysis with SAS has been designed by industry experts to provide learners with everything they need to enhance their skills and knowledge in their chosen area of study. Enrol on the Clinical Data Analysis with SAS today, and learn from the very best the industry has to offer! This best selling Clinical Data Analysis with SAS has been developed by industry professionals and has already been completed by hundreds of satisfied students. This in-depth Clinical Data Analysis with SAS is suitable for anyone who wants to build their professional skill set and improve their expert knowledge. The Clinical Data Analysis with SAS is CPD-accredited, so you can be confident you're completing a quality training course will boost your CV and enhance your career potential. The Clinical Data Analysis with SAS is made up of several information-packed modules which break down each topic into bite-sized chunks to ensure you understand and retain everything you learn. After successfully completing the Clinical Data Analysis with SAS , you will be awarded a certificate of completion as proof of your new skills. If you are looking to pursue a new career and want to build your professional skills to excel in your chosen field, the certificate of completion from the Clinical Data Analysis with SAS will help you stand out from the crowd. You can also validate your certification on our website. We know that you are busy and that time is precious, so we have designed the Clinical Data Analysis with SAS to be completed at your own pace, whether that's part-time or full-time. Get full course access upon registration and access the course materials from anywhere in the world, at any time, from any internet-enabled device. Our experienced tutors are here to support you through the entire learning process and answer any queries you may have via email.
Data Protection and Clinical Trials
Description Clinical Herbalism Diploma Embarking on a journey to understand the natural healing powers of plants and herbs, the Clinical Herbalism Diploma offers an expansive and comprehensive education tailored to those who seek to enrich their knowledge and skills in the field of herbal medicine. The course structure aligns with the growing demand for alternative and complementary medical practices, specifically focusing on the subject of clinical herbalism. Available online, this course ensures flexibility and accessibility for students across the globe, providing them with a strong foundation in both theory and practical application of herbalism. The Clinical Herbalism Diploma commences with an insightful Introduction to Clinical Herbalism. This segment sets the stage for the entire course, presenting an overview of the philosophy and principles that underpin the art and science of using plants for medicinal purposes. Students gain an understanding of the historical context and modern applications, allowing them to appreciate the relevance and growing importance of herbal medicine in healthcare today. Following the introduction, the Herbal Materia Medica section guides students through a systematic exploration of various plants, herbs, and their properties. This extensive study includes an in-depth examination of the characteristics, uses, and healing benefits of a wide array of botanical materials. Herbal Pharmacology builds on this knowledge, shedding light on the chemical components within herbs, their interactions within the body, and the physiological effects they can induce. This helps students grasp how herbs function medicinally and how they can be used safely and effectively. The Clinical Herbalism Diploma course also focuses on Understanding Herbal Therapeutics. This vital component educates students about the application of herbal remedies to treat and prevent specific ailments, tailoring the use of herbs to individual needs. Herbalism and Nutrition explores the synergistic relationship between diet and herbal medicine. Students learn how to support overall wellness and address specific health conditions through a combination of nutritional choices and herbal interventions. The next section, Herbal Preparations and Formulas, equips students with practical skills in creating herbal products. This encompasses the creation of tinctures, salves, teas, and more, laying the foundation for effective herbal practice. Herbal Consultations and Client Care are integral to the Clinical Herbalism Diploma. Here, students develop the communication and interpersonal skills necessary to interact with clients, conduct assessments, and offer tailored herbal treatments. A comprehensive look into Herbalism and Modern Medicine follows, emphasizing the integration and collaboration between herbal medicine and conventional medical practices. This reflects the growing trend of interdisciplinary care within the healthcare system. In Developing a Herbal Practice, students receive guidance on how to establish and manage a professional herbal practice. This includes ethical considerations, business planning, and legal compliance. Lastly, the Clinical Herbalism Diploma concludes with a thought-provoking exploration of The Future of Clinical Herbalism. Students are encouraged to reflect on current trends, emerging research, and potential future developments in the field. Offered entirely online, the Clinical Herbalism Diploma provides a flexible learning environment that caters to students from various walks of life. It seeks to instil a profound appreciation and mastery of herbal medicine, imparting a valuable skill set that not only enhances personal wellbeing but also opens doors to professional opportunities in a growing industry. Without any doubt, this diploma serves as a stepping stone to a rewarding and meaningful career, allowing students to harness the timeless wisdom of nature for healing, wellness, and empowerment. What you will learn 1:Introduction to Clinical Herbalism 2:Herbal Materia Medica 3:Herbal Pharmacology 4:Understanding Herbal Therapeutics 5:Herbalism and Nutrition 6:Herbal Preparations and Formulas 7:Herbal Consultations and Client Care 8:Herbalism and Modern Medicine 9:Developing a Herbal Practice 10:The Future of Clinical Herbalism Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.
Boost your medical administration career with our comprehensive bundle of 8 courses titled: Clinical Governance, Medical Law with Administration of Medicines. Within this collection, you will find 3 QLS endorsed courses including GP - Clinical Governance, Medical Law, and Control and Administration of Medicines Online Training Course. Each course comes with a hardcopy certificate, ensuring proof of your new qualifications. Additionally, this bundle provides you with 5 relevant CPD QS accredited courses. This includes Clinical Observations Skills, Verification of Death Training for Nurses, Initial Training of Community Health Agents, Observation Skills for Carers, and Basic Life Support. Through this bundle, gain extensive knowledge of Clinical Governance and Medical Law. Upgrade your skillset and reach new professional heights with this comprehensive bundle of theoretical courses. Key Features of the Clinical Governance, Medical Law with Administration of Medicines Bundle: 3 QLS-Endorsed Courses: We proudly offer 3 QLS-endorsed courses within our Clinical Governance, Medical Law with Administration of Medicines bundle, providing you with industry-recognized qualifications. Plus, you'll receive a free hardcopy certificate for each of these courses. QLS Course 01: GP - Clinical Governance QLS Course 02: Medical Law QLS Course 03: Control and Administration of Medicines Online Training Course 5 CPD QS Accredited Courses: Additionally, our bundle includes 5 relevant CPD QS accredited courses, ensuring that you stay up-to-date with the latest industry standards and practices. Course 01: Clinical Observations Skills Course 02: Verification of Death Training for Nurses Course 03: Initial Training of Community Health Agents Course 04: Observation Skills for Carers Course 05: Basic Life Support In Addition, you'll get Five Career Boosting Courses absolutely FREE with this Bundle. Course 01: Professional CV Writing Course 02: Job Search Skills Course 03: Self-Esteem & Confidence Building Course 04: Professional Diploma in Stress Management Course 05: Complete Communication Skills Master Class Convenient Online Learning: Our Clinical Governance, Medical Law with Administration of Medicines courses are accessible online, allowing you to learn at your own pace and from the comfort of your own home. Learning Outcomes: Understand the principles and policies of Clinical Governance. Gain an in-depth knowledge of Medical Law. Learn the Control and Administration of Medicines. Develop skills for performing Clinical Observations. Understand the process of Verification of Death Training for Nurses. Learn about the Initial Training of Community Health Agents. Acquire Observation Skills for Carers and Basic Life Support. This bundle of courses provides a comprehensive overview of Clinical Governance, Medical Law, and Administration of Medicines. The courses focus on the theoretical underpinnings of each topic, providing learners with a robust foundation of knowledge. With this, you will understand the nuances of Clinical Governance, how Medical Law impacts healthcare practice, and the proper Control and Administration of Medicines. The additional CPD QS accredited courses expand your skills in Clinical Observations, Verification of Death, and Basic Life Support. The knowledge gained from these courses will be highly beneficial in strengthening your credentials and improving the quality of care provided. CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Healthcare professionals seeking to enhance their knowledge of Clinical Governance and Medical Law. Administrators within the healthcare sector aiming to understand the Administration of Medicines. Nurses looking to expand their skills, including Verification of Death and Basic Life Support. Individuals interested in starting a career in healthcare administration. Career path Clinical Governance Manager: £40,000 - £60,000 per annum Medical Law Consultant: £50,000 - £80,000 per annum Healthcare Administrator: £22,000 - £40,000 per annum Community Health Agent: £18,000 - £30,000 per annum Carer: £20,000 - £30,000 per annum Nurse Practitioner: £35,000 - £50,000 per annum Certificates Digital certificate Digital certificate - Included Hard copy certificate Hard copy certificate - Included
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