Course Summary

Regulatory authorities tend to abide by the maxim that ‘If it isn’t documented, it didn’t happen’. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this short course we describe important examples of the documents designated by ICH GCP as essential to the conduct of a clinical trial.

Who will benefit from this module?

This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.

Learning Objectives

• Identify essential documents for a clinical trial
• Distinguish contents of trial master files at the sponsor’s office and at the investigational site
• Outline the contents of a clinical protocol
• Outline the contents of an investigator’s brochure
• Identify typical source documents
• Describe the role of the case report form
• Identify the types of report generated by sponsor, investigator and monitor before, during and on completion of a trial

Module Outline

Key topics covered in this module include:

• Essential documents
• Trial master files
• Clinical protocol
• Investigator’s brochure
• Source documents
• Case report form
• Reports

Assessment - Multiple-choice assessment.