Course description

This comprehensive course provides healthcare professionals with an in-depth understanding of Good Clinical Practice (GCP), an international quality standard for the conduct of clinical trials. Participants will learn about the ethical and scientific principles guiding clinical research, the roles and responsibilities of clinical trial stakeholders, and the regulatory requirements ensuring the safety and well-being of trial participants. Through a blend of theoretical knowledge and practical examples, this course aims to enhance the quality and reliability of clinical trial data and foster adherence to ethical standards in clinical research.

Course Outline

Main Topics

  1. Introduction to Good Clinical Practice (GCP)

    • Definition and Importance
    • Historical Background and Evolution
  2. Ethical and Scientific Principles

    • Informed Consent
    • Confidentiality and Data Protection
    • Risk-Benefit Assessment
  3. Roles and Responsibilities

    • Investigators
    • Sponsors
    • Institutional Review Boards (IRBs) / Ethics Committees
  4. Clinical Trial Protocol

    • Designing a Protocol
    • Amendments and Updates
  5. Regulatory Requirements

    • International Guidelines (ICH-GCP)
    • Local Regulations and Compliance
  6. Monitoring and Auditing

    • Monitoring Plans
    • Auditing Procedures
  7. Data Management and Reporting

    • Data Collection and Management
    • Adverse Event Reporting
  8. Quality Assurance and Control

    • Standard Operating Procedures (SOPs)
    • Continuous Quality Improvement

What Will I Learn?

  • Understand the fundamentals of Good Clinical Practice (GCP).
  • Comprehend ethical and scientific principles in clinical research.
  • Identify the roles and responsibilities of key clinical trial stakeholders.
  • Design and implement a robust clinical trial protocol.
  • Navigate international and local regulatory requirements.
  • Develop and execute effective monitoring and auditing plans.
  • Manage and report clinical trial data accurately.
  • Apply quality assurance and control measures in clinical trials.

Targeted Audience

  • Clinical Research Coordinators
  • Principal Investigators
  • Clinical Trial Monitors
  • Regulatory Affairs Professionals
  • Clinical Data Managers
  • Medical Students and Residents
  • Healthcare Professionals involved in Clinical Research

Total Course Duration

00 Hour 00 Minute

Materials Included

  • Course Syllabus
  • Lecture Slides and Notes
  • Reading Materials and References
  • Case Studies and Practical Examples
  • Quizzes and Assessments
  • Certificate of Completion

Requirements/Instructions

  • Basic understanding of clinical research concepts.
  • Reliable internet connection for accessing online materials.
  • Active participation in all course activities and discussions.
  • Completion of all quizzes and assessments to receive certification.

What will i learn?

  • Understand the fundamentals of Good Clinical Practice (GCP).
  • Comprehend ethical and scientific principles in clinical research.
  • Identify the roles and responsibilities of key clinical trial stakeholders.
  • Design and implement a robust clinical trial protocol.
  • Navigate international and local regulatory requirements.
  • Develop and execute effective monitoring and auditing plans.
  • Manage and report clinical trial data accurately.
  • Apply quality assurance and control measures in clinical trials.

Requirements

  • Basic understanding of clinical research concepts.
  • Reliable internet connection for accessing online materials.
  • Active participation in all course activities and discussions.
  • Completion of all quizzes and assessments to receive certification.

Frequently asked question

GCP is an international quality standard for designing, conducting, recording, and reporting clinical trials that involve human participants. It ensures that the rights, safety, and well-being of participants are protected and that the clinical trial data are credible and accurate.

This course is ideal for Clinical Research Coordinators, Principal Investigators, Clinical Trial Monitors, Regulatory Affairs Professionals, Clinical Data Managers, Medical Students, Residents, and other Healthcare Professionals involved in clinical research.

While prior experience in clinical research is beneficial, it is not mandatory. The course is designed to cater to both beginners and experienced professionals seeking to enhance their knowledge of GCP.

The total course duration is self-paced, allowing participants to complete it at their own convenience. It is designed to be comprehensive yet flexible to fit into busy schedules.

Yes, participants who successfully complete all course activities, quizzes, and assessments will receive a Certificate of Completion.

The course includes a syllabus, lecture slides and notes, reading materials and references, case studies, practical examples, quizzes, assessments, and a Certificate of Completion.

The course is delivered online through a combination of video lectures, reading materials, case studies, and interactive assessments. Participants can access the content from any device with an internet connection.

Yes, there are quizzes and assessments throughout the course to evaluate your understanding of the material. Completion of these assessments is required to earn the Certificate of Completion.

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Lectures

23

Skill level

Intermediate

Expiry period

Lifetime

Certificate

Yes

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