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Fundamentals of Good Clinical Practice: Prep and Personnel · LearnSpace
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Fundamentals of Good Clinical Practice: Prep and Personnel

Курс от Novartis
Начальный≈ 2.6 чАнглийский
О курсеНавыкиПрограммаПреподаватели

О курсе

Welcome to 'Fundamentals of Good Clinical Practice: Prep and Personnel'! This course is designed to introduce you to preparing for a clinical trial. This is Course Two in the Clinical Trial Teams series - the first course 'Introduction to Good Clinical Practice' provides background on what clinical trials are as well as the basic principles and practices of GCP. If you are new to the world of clinical research, we suggest starting your journey with Course One. In Course Two, we turn our attention to the conduct of clinical trials, exploring in detail the role of the Investigator and site staff throughout a study. Whether you are new to the field or seeking to refresh your knowledge, this course will equip you with the necessary understanding to begin to navigate the complex world of clinical research. The course is divided into several modules, each covering specific stages of a clinical trial. The modules include a variety of videos, a fictional case study and interactive quizzes to reinforce your learning. We are excited to embark on this learning journey with you as we delve into the world of Good Clinical Practice. Enroll now and start building a strong foundation in the conduct of clinical research!

Навыки, которые вы освоите

Good Clinical Practices (GCP)Clinical TrialsClinical Research EthicsInstitutional Review Board (IRB)Clinical Data ManagementClinical ResearchClinical Research CoordinationDrug DevelopmentDocument Management

Программа курса

3 модулей · 28 учебных материалов

01Preparing for a Clinical Trial5 материалов

Introduction to Course 2: Fundamentals of Good Clinical Practice

Introduction to the courseВидеоRe-introduction to our charactersЧтение

Site Selection Visit

Preparing for a Site Selection VisitВидеоAbout Site Selection VisitsВидео

End of Module Assessment

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Novartis Learning

Преподаватель курса

Fundamentals of Good Clinical Practice: Prep and Personnel
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Обучение на Coursera

≈ 2.6 ч

3 модулей

Язык: Английский

Часть программы вашего университета
Week One Graded AssessmentЗадание
02Preparing for a Clinical Trial, part 213 материалов

Essential Documents

Essential Documents for the IRB/IECВидеоWhat are Essential Documents?ВидеоList of Essential DocumentsЧтениеTest Your Knowledge - Essential DocumentsЗадание

The IRB/IEC

Introducing the IRB/IECВидеоWorking with the IRB/IECВидеоIRB/IEC Submission and ApprovalВидео

Source Data

Source Data & ALCOA+ВидеоCase Report Forms (CRF)ВидеоElectronic Medical RecordsВидеоRequirements for Electronic Medical RecordsЧтениеAssessment of Electronic Medical RecordsВидео

End of Module Assessment

Week Two Graded AssessmentЗадание
03Investigator and Site Staff10 материалов

Investigator's Responsibilities

Responsibilities of an InvestigatorВидеоBecoming an InvestigatorВидеоFinancial DisclosuresЧтениеForm FDA 1572ВидеоTest Your Knowledge - Investigator's ResponsibilitiesЗадание

Site Staff

Maintaining Oversight of TrialsВидеоSite Staff and Delegation of DutiesЧтениеOnboarding and Training Site StaffВидеоTest Your Knowledge - Site StaffЗадание

End of Module Assessment

Week Three Graded AssessmentЗадание