102 Courses

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.

Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance of data integrity in clinical research are required by law and/or established as expectations in regulatory guidance. The data are reviewed in regulatory applications or during regulatory inspections of clinical trial sponsor and investigational sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the organizations or individuals concerned. This course explains the requirements and describes principles and practices that should be followed by trial sponsors, investigators and other clinical research personnel to assure regulators of data integrity.

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support

Flash Sale (£300 OFF) 30 in 1 Bundle| 300 CPD Points| Free PDF & QLS Hardcopy Certificate |Tutor Support|Lifetime Access

***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. But that's not all. When you enrol in Clinical Project Manager (CPM) Online Training, you'll receive 30 CPD-Accredited PDF Certificates, Hard Copy Certificates, and our exclusive student ID card, all absolutely free. 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

***24 Hour Limited Time Flash Sale*** Clinical Trial Administrator (CTA) 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 Trial Administrator (CTA) 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 Trial Administrator (CTA) 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. But that's not all. When you enrol in Clinical Trial Administrator (CTA) Online Training, you'll receive 30 CPD-Accredited PDF Certificates, Hard Copy Certificates, and our exclusive student ID card, all absolutely free. Courses Are Included In this Clinical Trial Administrator (CTA) Career Bundle: Course 01: Medical & Clinical Administration Diploma Course 02: Project Management Course 03: Agile Project Management Course 04: Level 5 Diploma in Leadership and Management for Adult Care Course 05: Diploma in Operations Management 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 Trial Administrator (CTA), 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 Trial Administrator (CTA) today and take the first step towards achieving your goals and dreams. Why buy this Clinical Trial Administrator (CTA)? Free CPD Accredited Certificate upon completion of Clinical Trial Administrator (CTA) Get a free student ID card with Clinical Trial Administrator (CTA) Lifetime access to the Clinical Trial Administrator (CTA) course materials Get instant access to this Clinical Trial Administrator (CTA) course Learn Clinical Trial Administrator (CTA) from anywhere in the world 24/7 tutor support with the Clinical Trial Administrator (CTA) course. Start your learning journey straightaway with our Clinical Trial Administrator (CTA) Training! Clinical Trial Administrator (CTA) 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 Trial Administrator (CTA) 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 Trial Administrator (CTA) course. After passing the Clinical Trial Administrator (CTA) 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 Trial Administrator (CTA) course is ideal for: Students seeking mastery in Clinical Trial Administrator (CTA) Professionals seeking to enhance Clinical Trial Administrator (CTA) skills Individuals looking for a Clinical Trial Administrator (CTA)-related career. Anyone passionate about Clinical Trial Administrator (CTA) Requirements This Clinical Trial Administrator (CTA) doesn't require prior experience and is suitable for diverse learners. Career path Clinical Trial Manager Clinical Research Coordinator Clinical Operations Manager Clinical Project Manager Director 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

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.

A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.