In the intricate world of healthcare, clinical research is a beacon, shining light on innovations and advancements. Dive into 'Clinical Research Administration: Navigating the Healthcare Landscape', an expertly curated journey that marries in-depth knowledge with actionable strategies. This course will guide you from the foundations of clinical research to its evolving future. You'll traverse trial designs, the imperatives of ethics, data intricacies, and quality controls, ensuring you're equipped to lead, innovate, and make pivotal decisions within the clinical research realm. Learning Outcomes Gain a robust understanding of the clinical research ecosystem and its administration. Design and plan effective clinical trials while ensuring ethical and regulatory compliance. Master the art of data management, ensuring accuracy and reliability. Oversee trial monitoring, auditing, and meticulous safety reporting. Analyse clinical data proficiently and forecast the future trends in clinical research. Why choose this Clinical Research Administration: Navigating the Healthcare Landscape course? Unlimited access to the course for a lifetime. Opportunity to earn a certificate accredited by the CPD Quality Standards after completing this course. Structured lesson planning in line with industry standards. Immerse yourself in innovative and captivating course materials and activities. Assessments are designed to evaluate advanced cognitive abilities and skill proficiency. Flexibility to complete the Clinical Research Associate: Administration & Navigating the Healthcare Landscape 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. Who is this Clinical Research Administration: Navigating the Healthcare Landscape course for? Aspiring clinical researchers poised to shape the future of healthcare. Healthcare administrators seeking specialised knowledge in research. Medical students aiming to bolster their understanding of clinical trials. Ethics committee members desiring a broader perspective. Quality assurance professionals in the healthcare sector. Career path Clinical Research Coordinator: £25,000 - £40,000 Clinical Data Manager: £35,000 - £60,000 Clinical Research Associate: £30,000 - £50,000 Regulatory Affairs Specialist: £40,000 - £70,000 Clinical Trials Auditor: £40,000 - £65,000 Clinical Research Manager: £50,000 - £80,000 Prerequisites This Clinical Research Associate: Administration & Navigating the Healthcare Landscape does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Clinical Research Associate: Administration & Navigating the Healthcare Landscape 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 Module 01: Introduction to Clinical Research Administration Introduction to Clinical Research Administration 00:15:00 Module 02: Clinical Trial Design and Planning Ethics and Regulatory Compliance 00:11:00 Module 03: Ethics and Regulatory Compliance Ethics and Regulatory Compliance 00:13:00 Module 04: Institutional Review Boards (IRBs) and Ethics Committees Institutional Review Boards (IRBs) and Ethics Committees 00:10:00 Module 05: Data Management and Recordkeeping Data Management and Recordkeeping 00:12:00 Module 06: Safety Reporting and Adverse Events Safety Reporting and Adverse Events 00:10:00 Module 07: Clinical Trial Monitoring and Auditing Clinical Trial Monitoring and Auditing 00:09:00 Module 08: Study Site Management and Quality Control Study Site Management and Quality Control 00:17:00 Module 09: Data Analysis and Reporting Data Analysis and Reporting 00:09:00 Module 10: The Future of Clinical Research The Future of Clinical Research 00:10:00
This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.
This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.
Description Drug Design And Discovery Diploma Discover the fascinating world of drug development with the Drug Design And Discovery Diploma, an online course that demystifies the intricate processes and techniques used in the pharmaceutical industry. With advancements in medicine and technology, the need for skilled professionals in the realm of drug design and discovery is paramount. This diploma ensures you are well-equipped with the knowledge and expertise required in this ever-evolving sector. The Drug Design And Discovery Diploma begins with an introduction to drug design and discovery, laying the foundation for the comprehensive topics to follow. It explains the significance of developing new therapeutic agents and the challenges faced in the initial stages of drug discovery. Next, the course shifts its focus to target identification and validation, a pivotal step in ensuring that potential drugs interact with the desired molecular structures within the body. This is followed by an exploration of computational methods in drug design, where learners will be introduced to the latest software tools and techniques utilised to design new drug molecules efficiently. High throughput screening, a key technique used in modern drug discovery to quickly evaluate the effects of thousands of compounds, is also covered extensively in the course. The aim here is to familiarise students with the methodologies that facilitate rapid identification of potential drug candidates. One of the crucial aspects of drug design is understanding the relationship between a drug's chemical structure and its pharmacological activity. The section on Structure-Activity Relationship (SAR) Analysis helps elucidate this complex interplay, providing students with insights into how tiny molecular changes can significantly affect a drug's efficacy and safety. The Drug Design And Discovery Diploma also delves into drug metabolism and pharmacokinetics. Here, learners get an understanding of how drugs are absorbed, distributed, metabolised, and excreted by the body, ensuring they can design drugs that not only work effectively but are also safe for consumption. Toxicology and safety profiling follow next, teaching students the importance of assessing the potential adverse effects of new drug candidates. This knowledge is vital, ensuring that any potential drug has minimal side effects when administered. Before any drug reaches the market, it undergoes rigorous testing. The course provides a comprehensive overview of both preclinical and clinical trials, educating learners on the stages and methodologies involved in ensuring a drug's safety and effectiveness. An important component of drug development is how it is delivered to the targeted site in the body. The section on drug delivery systems offers insights into the various methods and technologies available to transport drugs effectively within the body. Finally, the Drug Design And Discovery Diploma concludes with a look at the future trends and challenges in the field. As the pharmaceutical industry is always evolving, it's essential for professionals to stay updated with the latest developments and potential hurdles they might face. In summary, the Drug Design And Discovery Diploma is a comprehensive online course that provides a deep understanding of the modern drug development process. From initial design to eventual market release, this course equips learners with the skills and knowledge required to excel in the dynamic world of drug discovery. What you will learn 1:Introduction to Drug Design and Discovery 2:Target Identification and Validation 3:Computational Methods in Drug Design 4:High Throughput Screening 5:Structure-Activity Relationship (SAR) Analysis 6:Drug Metabolism and Pharmacokinetics 7:Toxicology and Safety Profiling 8:Preclinical and Clinical Trials 9:Drug Delivery Systems 10:Future Trends and Challenges 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.
Overview This comprehensive course on Clinical Data Analysis with SAS will deepen your understanding on this topic. After successful completion of this course you can acquire the required skills in this sector. This Clinical Data Analysis with SAS comes with accredited certification, which will enhance your CV and make you worthy in the job market. So enrol in this course today to fast track your career ladder. How will I get my certificate? You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate. Who is This course for? There is no experience or previous qualifications required for enrolment on this Clinical Data Analysis with SAS. It is available to all students, of all academic backgrounds. Requirements Our Clinical Data Analysis with SAS is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible with tablets and smartphones so you can access your course on Wi-Fi, 3G or 4G. There is no time limit for completing this course, it can be studied in your own time at your own pace. Career Path Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management, Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc. Course Curriculum 5 sections • 30 lectures • 01:54:00 total length •Course Promo: 00:01:00 •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 •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 •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 - Clinical Data Analysis with SAS: 00:00:00
Enrolling in an Administration of Clinical Research course is essential in today's world, where clinical trials and medical advancements play a pivotal role in public health. The Administration of Clinical Research course curriculum covers comprehensive aspects of Clinical Research Administration, including clinical trial design, regulatory compliance, data management, and quality control. Learning Clinical Research Administration equips you with the skills to manage clinical trials effectively, ensuring that they are conducted ethically and efficiently. This knowledge is crucial for improving patient outcomes and advancing medical science. In your professional career, expertise in Clinical Research Administration opens up numerous job opportunities, particularly in the UK, where the demand for skilled professionals in this field is growing. The average salary for Clinical Research Administrators in the UK ranges from £35,000 to £50,000 per year, reflecting the value of this specialization. The sector of Clinical Research Administration is expanding, with a projected growth rate of around 6-8% annually, driven by the increasing need for innovative medical solutions and regulatory oversight. By mastering Clinical Research Administration, you enhance your employability and contribute to the advancement of medical research, making a significant impact on global health. Key Features: CPD Certified Administration of Clinical Research Course Free Certificate from Reed CIQ Approved Administration of Clinical Research Course Developed by Specialist Lifetime Access Course Curriculum Module 01: Introduction to Clinical Research Administration Module 02: Clinical Trial Design and Planning Module 03: Ethics and Regulatory Compliance Module 04: Institutional Review Boards (IRBs) and Ethics Committees Module 05: Data Management and Recordkeeping Module 06: Safety Reporting and Adverse Events Module 07: Clinical Trial Monitoring and Auditing Module 08: Study Site Management and Quality Control Module 09: Data Analysis and Reporting Module 10: The Future of Clinical Research Learning Outcomes: Master clinical trial design strategies for optimal planning. Navigate ethical and regulatory frameworks with confidence and precision. Implement robust data management systems for seamless recordkeeping. Ensure safety reporting protocols meet industry standards and requirements. Conduct thorough clinical trial monitoring and auditing processes effectively. Utilise site management techniques to uphold quality control standards impeccably. CPD 10 CPD hours / points Accredited by CPD Quality Standards Administration of Clinical Research 1:59:16 1: Module 1: Introduction to Clinical Research Administration Preview 14:32 2: Module 2: Clinical Trial Design and Planning 11:21 3: Module 3: Ethics and Regulatory Compliance 13:21 4: Module 4: Institutional Review Boards (IRBs) and Ethics Committees 10:04 5: Module 5: Data Management and Recordkeeping 11:32 6: Module 6: Safety Reporting and Adverse Events 10:12 7: Module 7: Clinical Trial Monitoring and Auditing 09:18 8: Module 8: Study Site Management and Quality Control 17:18 9: Module 9: Data Analysis and Reporting 09:17 10: Module 10: The Future of Clinical Research 10:21 11: CPD Certificate - Free 01:00 12: Leave A Review 01:00 Who is this course for? This Administration of Clinical Research course is accessible to anyone eager to learn more about this topic. Through this course, you'll gain a solid understanding of Administration of Clinical Research. Moreover, this course is ideal for: Aspiring clinical research administrators seeking comprehensive knowledge. Healthcare professionals transitioning into clinical research roles. Individuals passionate about contributing to advancements in healthcare. Researchers eager to enhance their understanding of trial administration. Students pursuing careers in pharmaceuticals or healthcare management. Requirements There are no requirements needed to enrol into this Administration of Clinical Research course. We welcome individuals from all backgrounds and levels of experience to enrol into this Administration of Clinical Research course. Career path After finishing this Administration of Clinical Research course you will have multiple job opportunities waiting for you. Some of the following Job sectors of Administration of Clinical Research are: Clinical Research Coordinator - £30K to £40K/year. Data Manager - £35K to £45K/year. Clinical Trial Auditor - £40K to £50K/year. Regulatory Affairs Specialist - £45K to £55K/year. Certificates Digital certificate Digital certificate - Included Reed Courses Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.
Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 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 14 Points Development Level Develop
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!
Description Parkinson's Disease Awareness Diploma Parkinson's disease, also known as PD, is a disorder that impacts the brain. This causes the individual to suffer from impaired movements, such as stiffness and shaking, that deteriorate with time. More specifically, PD is attributed to when an individual loses nerve cells within the brain's substantia nigra, resulting in reduced dopamine production. Dopamine is a neurotransmitter that is crucial in regulating movement in an individual. Several PD symptoms can be attributed to lowering this neurotransmitter's production. It is indistinct as to what exactly causes Parkinson's disease. Scholars opine that blending genes and the environment increases the odds of falling prey to this condition. An in-depth understanding of the condition and the issues tackled by PD are requisites for providing care. This Parkinson's Disease Awareness Diploma course will illuminate students on the hurdles individuals face with PD and equip them with the best practices to dispense while helping patients overcome those obstacles. People experience Parkinson's Disease in various ways. Although there are many PD symptoms, not all patients will encounter them, and if they do, the symptoms will not automatically occur in the same magnitude and order. PD progresses in typical patterns, which scholars have broken down into stages. PD is chronic and progressive. It influences the brain, which causes a plethora of movement impediments such as stiffness, shaking, and difficulty with balancing, coordination, and walking. Symptoms typically deteriorate as time advances. People may even experience issues with talking. This Parkinson's Disease Awareness Diploma course outlines Parkinson's disease to enable students to understand the condition better. It equips them with the knowledge of its symptoms and ways to identify them. It elucidates the various stages of PD and the way the condition progresses. The course supplies an insight into the practices and approaches to be used while caring for patients ill with PD, both physical and emotional. This informative Parkinson's Disease Awareness Diploma course analyses the causal factors behind the condition, its possible signs, and the process of diagnosing and treating it. You will be acquainted with the impact of the disease on the patient's relationships and everyday life during its initial stages and how those difficulties progress as the condition advances later. This Parkinson's Disease Awareness Diploma course examines and elucidates the methods caregivers adopt while tackling deteriorating symptoms and enlists useful links to accessible resources. This Parkinson's Disease Awareness Diploma course is ideal for those looking to broaden their knowledge about Parkinson's disease and those caring for PD patients who are potential caregivers. Individuals working in the care sector, including but not limited to general practitioners, mental health specialists and healthcare staff, will equally benefit from this course. Additionally, carers working in care facilities and domiciliary situations, managers, family members, relatives and friends of patients will find this course incredibly insightful. What you will learn 1: Parkinson's disease 2: Symptoms and Diagnosis 3: After Diagnosis 4: Treatment plan 5: Cam Therapies and exercise 6: Mental Health and Clinical Trials 7: Maintaining Relationships and Career 8: Advanced PD 9: Caregiver and Financial Health 10: Housing Options 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.