course
Good Clinical Practices (GCP): Protocol, case report, and initial documentation
Good Clinical Practices (GCP): Protocol, case report, and initial documentation
Good Clinical Practices (GCP): Protocol, case report, and initial documentation

About the Course

Introduction to this course: 

This course covers the essentials of clinical trial documentation, focusing on the Protocol and Case Report Forms, underscoring the crucial role of Quality Assurance (QA) in ensuring study quality. It also covers best practices for early trial stages.


Who should attend: 

This course is ideal for clinical trial coordinators, research associates, QA professionals, regulatory affairs specialists, and anyone involved in clinical trial management.


Learning Outcomes: 

By the end of this lesson, you will be able to:

  • Identify key documents required in clinical trials

  • Explain the importance of QA in clinical trial planning and execution

  • Utilize best practices for developing and reviewing clinical trial protocols


What will I gain: 

Participants will gain a comprehensive understanding of clinical trials documentation and the essential role of QA in ensuring compliance and quality.


Prerequisites: 

Basic knowledge of clinical trials and familiarity with Good Clinical Practices (GCP) is recommended.


Additional information: 


Course duration:00:20:27

Course code/version (effective date): L-152/v1.0 (12/03/2024)

Course Categories

GxP Regulations
Course Progress
Not started
Enroll
Course Outline
  1. Good clinical practices: Protocol, case report and initial documentation
    1. Lesson 1: Clinical Trial Protocol and the role of QA in Clinical Trials
    2. Lesson 2: Common Findings in Protocol Review by QA
    3. Lesson 3: The Case Report Form and other documentation
    4. Reading: Clinical Data Management (CDM) - Glossary
  2. Additional resources
    1. Mind map: Good Clinical Practices
  3. Survey
    1. Course survey
course
Good Clinical Practices (GCP): Protocol, case report, and initial documentation
Good Clinical Practices (GCP): Protocol, case report, and initial documentation
Course Progress
Not started
Enroll

About the Course

Introduction to this course: 

This course covers the essentials of clinical trial documentation, focusing on the Protocol and Case Report Forms, underscoring the crucial role of Quality Assurance (QA) in ensuring study quality. It also covers best practices for early trial stages.


Who should attend: 

This course is ideal for clinical trial coordinators, research associates, QA professionals, regulatory affairs specialists, and anyone involved in clinical trial management.


Learning Outcomes: 

By the end of this lesson, you will be able to:

  • Identify key documents required in clinical trials

  • Explain the importance of QA in clinical trial planning and execution

  • Utilize best practices for developing and reviewing clinical trial protocols


What will I gain: 

Participants will gain a comprehensive understanding of clinical trials documentation and the essential role of QA in ensuring compliance and quality.


Prerequisites: 

Basic knowledge of clinical trials and familiarity with Good Clinical Practices (GCP) is recommended.


Additional information: 


Course duration:00:20:27

Course code/version (effective date): L-152/v1.0 (12/03/2024)

Course Outline
  1. Good clinical practices: Protocol, case report and initial documentation
    1. Lesson 1: Clinical Trial Protocol and the role of QA in Clinical Trials
    2. Lesson 2: Common Findings in Protocol Review by QA
    3. Lesson 3: The Case Report Form and other documentation
    4. Reading: Clinical Data Management (CDM) - Glossary
  2. Additional resources
    1. Mind map: Good Clinical Practices
  3. Survey
    1. Course survey

Course Categories

GxP Regulations
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