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Fundamentals of Good Clinical Practice: Recruitment & Trial · LearnSpace
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Fundamentals of Good Clinical Practice: Recruitment & Trial

Курс от Novartis
Начальный≈ 4 чАнглийский
О курсеНавыкиПрограммаПреподаватели

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Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'! This is the third course in the Clinical Trial GCP series. It is designed to introduce you to the processes, procedures and documentation needed prior, during and after a clinical trial according to Good Clinical Practice (GCP). In Courses One and Two, we explored the foundations of clinical research, including the preparations and documentation needed to begin a trial as well as the role of the investigator, site staff and the IRB/IEC. We conclude our GCP studies with this final course. 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. Enroll now and start building a strong foundation in the conduct of clinical research!

Навыки, которые вы освоите

Good Clinical Practices (GCP)Clinical DocumentationInformed ConsentClinical TrialsClinical Research CoordinationClinical Research EthicsDrug DevelopmentPatient CommunicationClinical ResearchInstitutional Review Board (IRB)Regulatory ComplianceRecord Keeping

Программа курса

3 модулей · 44 учебных материалов

01Recruitment & Enrollment of Patients11 материалов

Introduction

Introduction to the courseВидеоRe-introduction to our charactersЧтение

Patient Recruitment Plan

Dr. Novel's Recruitment PlanЧтениеRecruitment PlanВидео

Site Initiation Visit

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Преподаватель курса

Fundamentals of Good Clinical Practice: Recruitment & Trial
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Обучение на Coursera

≈ 4 ч

3 модулей

Язык: Английский

Часть программы вашего университета
Preparing for Site Initiation VisitsВидео
About Site Initiation VisitsВидео

Patient Recruitment & Enrollment

Recruiting PatientsВидеоDiversity & Inclusion in RecruitmentЧтениеEnrolling PatientsВидеоBuilding Trust with PatientsВидео

End of Module Assessment

Week One Graded AssessmentЗадание
02Patient consent and working with vulnerable subjects 11 материалов

Informed Consent Process

Obtaining Informed ConsentЧтениеThe Informed Consent FormВидеоElectronic Informed Consent (eICF)ВидеоTest Your Knowledge - Informed ConsentЗадание

Vulnerable Subjects & Minors

Who are Vulnerable Subjects?ЧтениеRecruiting MinorsВидеоTest Your Knowledge - Vulnerable Subjects & MinorsЗадание

Ensuring Patient Understanding

Additional ConsiderationsВидеоOvercoming Language BarriersВидеоEnsuring Patient UnderstandingВидео

End of Module Assessment

Week Two Graded AssessmentЗадание
03Conducting a Clinical Trial22 материалов

Clinical Trial Documentation

Dr. Novel RecapЧтениеSource Documentation ChecklistВидеоRemember ALCOA+ЧтениеSource Notes & CRFВидеоAudit TrailsВидеоTest Your Knowledge - DocumentationЗадание

Data Flow

Data FlowВидеоTest Your Knowledge - Data FlowЗадание

Essential Documents

Essential Documents - RecapЧтениеTest Your Knowledge - Essential DocumentsЗадание

Adverse Events & Safety Reporting

Adverse EventsЧтениеAssessing Causality ЧтениеTest Your Knowledge - Adverse EventsЗадание

Monitoring Procedures and Protocol Compliance

Monitoring ProceduresВидеоImportance of Protocol ComplianceВидеоMonitoring - Further ReadingЧтениеSubmitting Protocol AmendmentsВидео

Audits & Inspections

Audits & InspectionsВидеоAudits vs InspectionsЧтениеTest Your Knowledge - Audits & InspectionsЗадание

Trial Close-out

Close-out & Archival Document MaintenanceВидео

End of Module Assessment

Week Three Graded AssessmentЗадание