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.
Getting Started The primary aim of the OTHM Level 3 Diploma in Business Management is to offer learners a comprehensive grasp of how businesses operate and are organised. This qualification is designed to equip learners with the foundational knowledge, comprehension, and skills relevant to various aspects of business operations. It encourages learners to research, explore, and assess key business elements, encompassing areas like Business Communication, The Business Environment, People Management, Customer Service, Finance, and Marketing. Key Benefits Gain a thorough comprehension of business operations and organisational structure Equips learners with essential knowledge, comprehension, and practical skills required in various aspects of business activities Encourages learners to conduct research and explore critical elements of the business field, Apply the knowledge and skills gained to real-world business situations Develop effective written and oral communication skills essential for successful business interactions. Key Highlights This qualification will offer learners the requisite skills and knowledge to enter the world of work in their chosen sector We will ensure your access to the first-class education needed to achieve your goals and dreams and to maximise future opportunities. Remember! The Assessment for the qualification is done based on assignments only, and you do not need to worry about writing any exam With the School of Business and Technology London, you can complete the qualification at your own pace, choosing online or blended learning from the comfort of your home. Learning and pathway materials and study guides developed by our qualified tutors will be available around the clock in our cutting-edge learning management system. Most importantly, at the School of Business and Technology London, we will provide comprehensive tutor support through our dedicated support desk. If you choose your course with blended learning, you will also enjoy live sessions with an assigned tutor, which you can book at your convenience. About Awarding Body OTHM is an established and recognised Awarding Organisation (Certification Body) launched in 2003. OTHM has already made a mark in the UK and global online education scenario by creating and maintaining a user-friendly and skill based learning environment. OTHM has both local and international recognition which aids OTHM graduates to enhance their employability skills as well as allowing them to join degree and/or Master top-up programmes. OTHM qualifications has assembled a reputation for maintaining significant skills in a wide range of job roles and industries which comprises Business Studies, Leadership, Tourism and Hospitality Management, Health and Social Care, Information Technology, Accounting and Finance, Logistics and Supply Chain Management. Entry Requirements Learners must be 18 years of demonstrate the ability to undertake the learning and Assessment A learner not from a majority English-speaking country must provide evidence of English language competency. Progression OTHM Level 4 diplomas Direct entry into a range of Bachelor's degree programmes Learners must request before enrolment to interchange unit(s) other than the preselected units shown in the SBTL website because we need to make sure the availability of learning materials for the requested unit(s). SBTL will reject an application if the learning materials for the requested interchange unit(s) are unavailable. Learners are not allowed to make any request to interchange unit(s) once enrolment is complete. UNIT1- Communication for Business Reference No : F/618/8192 Credit : 20 || TQT : 200 The primary objective of this unit is to impart learners with essential and critical skills needed for effective communication within a business setting. Learners will cultivate an understanding of various communication forms, including non-verbal, verbal, written, and IT. This knowledge will empower learners to proficiently convey messages by choosing the most appropriate communication method based on the message's specific context and content. UNIT2- The Business Environment Reference No : J/618/8193 Credit : 20 || TQT : 200 The primary goal of this unit is to equip learners with a comprehension of the idea of a business environment. Learners will foster an awareness of diverse business sectors, structures, and functions. Furthermore, learners will acquire insights into a business's inner and outer surroundings, where both micro and macroeconomic factors wield substantial influence over business operations. This knowledge will empower learners to evaluate a business's internal and external contexts proficiently. UNIT3- People Management Reference No : L/618/8194 Credit : 20 || TQT : 200 The primary objective of this unit is to furnish learners with the essential knowledge and insights required for proficiently guiding and supervising individuals within a business. Learners will cultivate an understanding of employee motivation, employee relationships, and performance management. This knowledge will enable learners to grasp the prerequisites for leaders and managers to facilitate and promote effective employee engagement. UNIT4- Customer Service Reference No : R/618/8195 Credit : 20 || TQT : 200 The primary goal of this unit is to equip learners with the essential knowledge and comprehension needed for effective performance in a customer service position. Learners will first establish a foundation in customer service basics, then explore customer types and strategies for fostering relationships with them within a business context. Building upon an understanding of various interpersonal skills, this unit will allow learners to showcase their ability to work independently and collaboratively in a team to deliver exceptional customer experiences. UNIT5- Finance in Business Reference No : Y/618/8196 Credit : 20 || TQT : 200 The primary objective of this unit is to impart learners with the foundational knowledge necessary for documenting financial transactions and generating financial statements. Learners will acquire an understanding of various economic and accounting methods, including the double-entry accounting system, budgeting, and investment assessment. This knowledge will empower learners to document financial transactions and create accounting statements proficiently. UNIT6- Marketing Reference No : D/618/8197 Credit : 20 || TQT : 200 The primary goal of this unit is to equip learners with the essential marketing knowledge and skills necessary to participate in marketing endeavours actively. This is complemented by understanding critical marketing and campaign principles, which are the basis for generating and delivering market research findings and a marketing campaign. Delivery Methods School of Business & Technology London provides various flexible delivery methods to its learners, including online learning and blended learning. Thus, learners can choose the mode of study as per their choice and convenience. The program is self-paced and accomplished through our cutting-edge Learning Management System. Learners can interact with tutors by messaging through the SBTL Support Desk Portal System to discuss the course materials, get guidance and assistance and request assessment feedbacks on assignments. We at SBTL offer outstanding support and infrastructure for both online and blended learning. We indeed pursue an innovative learning approach where traditional regular classroom-based learning is replaced by web-based learning and incredibly high support level. Learners enrolled at SBTL are allocated a dedicated tutor, whether online or blended learning, who provide learners with comprehensive guidance and support from start to finish. The significant difference between blended learning and online learning methods at SBTL is the Block Delivery of Online Live Sessions. Learners enrolled at SBTL on blended learning are offered a block delivery of online live sessions, which can be booked in advance on their convenience at additional cost. These live sessions are relevant to the learners' program of study and aim to enhance the student's comprehension of research, methodology and other essential study skills. We try to make these live sessions as communicating as possible by providing interactive activities and presentations. Resources and Support School of Business & Technology London is dedicated to offering excellent support on every step of your learning journey. School of Business & Technology London occupies a centralised tutor support desk portal. Our support team liaises with both tutors and learners to provide guidance, assessment feedback, and any other study support adequately and promptly. Once a learner raises a support request through the support desk portal (Be it for guidance, assessment feedback or any additional assistance), one of the support team members assign the relevant to request to an allocated tutor. As soon as the support receives a response from the allocated tutor, it will be made available to the learner in the portal. The support desk system is in place to assist the learners adequately and streamline all the support processes efficiently. Quality learning materials made by industry experts is a significant competitive edge of the School of Business & Technology London. Quality learning materials comprised of structured lecture notes, study guides, practical applications which includes real-world examples, and case studies that will enable you to apply your knowledge. Learning materials are provided in one of the three formats, such as PDF, PowerPoint, or Interactive Text Content on the learning portal. How does the Online Learning work at SBTL? We at SBTL follow a unique approach which differentiates us from other institutions. Indeed, we have taken distance education to a new phase where the support level is incredibly high.Now a days, convenience, flexibility and user-friendliness outweigh demands. Today, the transition from traditional classroom-based learning to online platforms is a significant result of these specifications. In this context, a crucial role played by online learning by leveraging the opportunities for convenience and easier access. It benefits the people who want to enhance their career, life and education in parallel streams. SBTL's simplified online learning facilitates an individual to progress towards the accomplishment of higher career growth without stress and dilemmas. How will you study online? With the School of Business & Technology London, you can study wherever you are. You finish your program with the utmost flexibility. You will be provided with comprehensive tutor support online through SBTL Support Desk portal. How will I get tutor support online? School of Business & Technology London occupies a centralised tutor support desk portal, through which our support team liaise with both tutors and learners to provide guidance, assessment feedback, and any other study support adequately and promptly. Once a learner raises a support request through the support desk portal (Be it for guidance, assessment feedback or any additional assistance), one of the support team members assign the relevant to request to an allocated tutor. As soon as the support receive a response from the allocated tutor, it will be made available to the learner in the portal. The support desk system is in place to assist the learners adequately and to streamline all the support process efficiently. Learners should expect to receive a response on queries like guidance and assistance within 1 - 2 working days. However, if the support request is for assessment feedback, learners will receive the reply with feedback as per the time frame outlined in the Assessment Feedback Policy.
Diploma in Law Level 3The Level 3 Diploma in Law is a 60-credit Ofqual regulated qualification and is the equivalent level to an A Level or Access to HE qualification. It has been designed for learners who wish to progress to a law degree but may not have the traditional entry qualifications usually required. The qualification provides learners with an introduction to law and the legal system as well as key academic, research and communication skills to support learners in their development. Key Highlights of Diploma in Law Level 3 qualification are: Program Duration: 9 Months (Fast Track 6 months duration course also available) Program Credits: 60 Designed for working Professionals Format: Online No Written Exam. The Assessment is done via Submission of Assignment Tutor Assist available Graded with Pass, Merit and Distinction Dedicated Student Success Manager Timely Doubt Resolution Regular Networking Events with Industry Professionals Become eligible to gain direct entry into relevant Undergraduate degree programme. Alumni Status No Cost EMI Option Requirements This Diploma in Law Level 3 (Accredited by Ofqual, UK and awarded by Qualifi, UK) qualifications has been designed to be accessible without artificial barriers that restrict access and progression. Learners will be expected to hold the following: Learners who have demonstrated some ability and possess Qualifications at Level 2 and Age: 16+ OR work experience in a business environment and demonstrate ambition with clear career goals; Level 3 qualification in another discipline and want to develop their careers in management. Career path On successful completion of a Level 3 Diploma in Law there are a number of progression opportunities. Learners may progress to: BA (Hons) Business Management Level 4 qualification such as the Athe Level 4 Extended Diploma in Business and Management Other level 4 qualifications Other Undergraduate Bachelor's degree programmes Employment or setting up own business Certificates Certificate of Achievement Hard copy certificate - Included Once you complete the course, you would be receiving a Physical hard copy of your Diploma along with its Transcript which we would Courier to your address via DHL or Royal Mail without any additional charge
Explore the intricate bond between plants and human societies in our Ethnobotany course. Uncover traditional plant uses, delve into botanical foundations, and master ethnobotanical research methods. Discover sustainability, biodiversity conservation, and future horizons in this interdisciplinary journey. Join us to deepen your understanding of the vital relationship shaping our cultural, ecological, and economic landscapes.
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A report is a short, sharp, concise document which is written for a particular purpose and audience. It generally sets outs and analyses a situation or problem, often making recommendations for future action. It is a factual paper, and needs to be clear and well-structured. This course will help you hone your report writing skills
This course covers the fundamental topics of statistical methodology, linear regression, and ordinary least squares that every statistician needs to know.
Facebook is the world’s largest social network. With over a billion users it’s very likely that a proportion of your target customer audience will have a Facebook account. In the ‘Social Media for Business’ course you’ll have been encouraged to research and investigate the preferred social media platforms used by your target audience, so you should have a good idea at this point if Facebook is one of the right platforms for you. Using Facebook in your business is about providing an effective means for your customers to interact with you and connect their friends to your business. Recommendation is the most powerful way a potential customer can be connected to a business, particularly when it’s being recommended by a friend. So if you know that a trusted friend likes a particular brand, you’re much more likely to engage with that brand. Facebook is essentially a platform designed to facilitate social interaction between people with whom you’ve already established some mutual recognition.
Explore the intricate facets of English law with our comprehensive guide. From Contract and Criminal Law to Human Rights, delve into the principles shaping the UK legal system. Gain insights into Equity, Trusts, Family, Employment Law, and more. Embark on a journey of legal understanding and refine your skills with practical legal research projects. Join us for an enriching exploration of English law's impact on society. Perfect for law students and professionals seeking a deep dive into the diverse legal landscape. Start your educational journey today!
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