Section

• • Good Clinical Practice

  • Announcements Forum
  • __________________________________________ Welcome to the Course Hello, my name is Henry Silverman and I will be your facilitator for this course.  You can contact me by email for any questions:  hsilverm@comcast.net

    
    

    
    
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  Instructions: Clicking on the section name will show / hide the section.

  

• 1

  Introduction to Good Clinical Practice

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    INTRODUCTION

  • Introduction to Best Clinical Practices: GCP and Roles and Responsibilities SCORM package
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    RESOURCES

  • Video: International Conference on Harmonisation & GCP URL
  • Good Clinical Practice Presentation Henry Silverman File
  • Introduction to Good Clinical Practice Global Health Training Centre URL
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    Activities

  • Lesson Activity - Introduction to ICH
  Topic
  1
• 2

  Trial Management I

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    INTRODUCTION

  • Module 3 - Recruitment and Retention SCORM package
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    RESOURCES

  • Key Players in Clinical Trials URL
  • Initiation Visit File
  • Source Docuements and CRFs File
  • Protocol NonAdherence File
  • Study Visits File
  Topic
  2
• 3

  Trial Management II

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    INTRODUCTION

  • Module 7 - Quality Control & Assurance SCORM package
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    RESOURCES

  • Study Protocol, Essential Documents, Recruitment URL
  • PreStudy and Essential Documents File
  • Quality Monitoring and Quality Assurance File
  Topic
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• 4

  Subject Management I Recruitment and Informed Consent

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  Subject Recruitment and Enrollment

  Screening

  Inclusion and Exclusion Criteria

  Informed Consent

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    INTRODUCTION

  • Module 4 - Informed Consent SCORM package
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    RESOURCES

  • Screening and Informed Consent File
  • The Process of Informed Consent URL
  Topic
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  Subject Management II Monitoring Clinical Trials

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    INTRODUCTION

  • Module 6 - Participant Safety & AE Reporting SCORM package
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    RESOURCES

  • Safety in Clinical Trials AEs and DSMBs URL
  • Safety in Clinical Trials File
  • Monitoring Clinical Trials File
  • Adverse Events Tamer File
  • DSMB Henry Silverman File
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    ACTIVITIES
    

  • Monitoring for Safety Lesson
  Topic
  5