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A clinical trial, particularly a late-phase commercial study, is a major project requiring collaboration between the sponsor and staff or contractor, on the one hand, and the clinical investigator(s) and other healthcare professionals on the other. Good communication among all parties is essential. In this short course we introduce the major roles in a typical clinical research project and outline their duties.
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
***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. 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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? 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