African Vaccines Regulatory Forum clinical trials inspections

Course information

This course is also available in the following languages :

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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles of the Declaration of Helsinki, and that the trial provides the necessary conditions for credible clinical trial data. There are a few exercises following the main content, which are designed to present practical examples of considerations for the preparation and conduct of GCP inspections.

Learning objective: By the end of this course, you should be able to:

• list the principles of GCP;
• perform GCP inspections efficiently;
• describe how to ensure the ethical, scientific, and data integrity of clinical trials;
• explain the mutual recognition of GCP inspection reports among the countries on the African continent where the AVAREF Inspection checklist and guideline for clinical trial inspections is being used; and
• participate effectively in joint GCP inspections when the opportunity or need arises.

Course duration: approximately 3 hours.

Certificates: A Record of Achievement will be available to participants who score at least 80% of the total points available in the final assessment. Participants who receive a Record of Achievement can also download an Open Badge for this course. Click here to learn how.

Course contents

• Module 1: Introduction:

  This introductory module gives an overview of GCP, outlines the structure of the training and gives an overview of the acronyms used throughout the course and the relevant resources related to the course content.

• Module 2: Preparing for GCP inspections:

  The participants learn about how to prepare for a GCP inspection in order to be able to conduct the inspection in an effective and professional way. The module focuses on: the inspection team; relevant information and documents; the detailed planning of the inspection; the preparation of the inspection team and the additional responsibilities of the team leader.

• Module 3: Conduct of the inspection – Overview :

  The module gives a brief general overview of the inspection process, preparing the learner for the upcoming detailed explanation of the stages.

• Module 4: Clinical trials inspection – Licensing and approvals:

  The participants learn about the various licenses and approvals that are required for the inspection. The focus is on: preliminary verification; license for clinical trial(s) at a specific site; regulatory approvals; ethics approvals and approved clinical trials protocol.

• Module 5: The clinical trials site:

  The learner is introduced to the main features of the sites of clinical trial. The focus is on: the clinic, and the pharmacy.

• Module 6: Documentation, quality assurance and contracts:

  The learner is taught about the various documents that are created during a clinical trial and is familiarized with how to verify them. The focus is on: documentation; the quality system of clinical trials; archiving and contracts and agreements.

• Module 7: Clinical trials participants:

  The module introduces the various stakeholders involved in the clinical trial and the inspection process. The focus is on: the sponsor; the investigator; other clinical personnel; the monitor and patients, participants and subjects

• Module 8: Participant information:

  The learner is informed about the importance of the proper information of patients during a clinical trial. The focus is on: informed consent forms; randomization; case report forms.

• Module 9: The clinical trials laboratories:

  The modules familiarizes with the importance of laboratories for the proper conduct of clinical trial the focus is on: clinical laboratories; bioanalytical laboratories; laboratory equipment and instruments.

• Module 10: Analysis:

  The module inform about the validation of analytical methods and how it helps to achieve reliable results that are necessary for making proper decisions on drug dosing and patient safety. The focus is on: analysis methods; sample analysis; statistical analysis.

• Module 11: Study reports :

  The learner is taught about the study report that is compiled after the completion of the clinical trial

• Module 12: Multicenter trials:

  The learner is familiarized with multicenter trials that are conducted simultaneously at different sites by several investigators following the same protocol.

• Module 13: Exit meeting and follow up actions:

  The module introduces the key elements of completing a clinical trial inspection. Focus is on: the exit meeting; the relevant follow-up actions.

• Assessment