Course Description

The Case Report Form Process

Course Description:

This course focuses on the data flow process for both paper and electronic Case Report Forms (CRFs). It outlines the responsibilities of the different parties involved, including sponsors designing CRFs and monitors training site personnel, and also looks into the key factors of data handling, including completion, data management, and query processing. Both the use of paper and electronic case report form processes are covered.  Examples of frequently found data entry errors will help monitors to develop the necessary reviewing skills.

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Perform and document the training of all parties involved in CRFs, particularly site personnel involved in the data handling process
  • Ensure traceability of all data points, including corrections and where to place data during clinical investigations
  • Learn differences between paper and electronic case report form processes

Who Should Enroll:

Monitors, investigators, study coordinators, and quality assurance, regulatory, sales, and marketing professionals wanting to understand the general requirements of the data handling process are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • Basic understanding of good clinical practice
  • Strong grasp of the mechanisms of initiating a clinical investigation site and conducting periodic monitoring of clinical investigation activities on the investigation site
  • The Periodic Monitoring Visit (ID 56)

Subject Matter Expert:
Danielle Giroud

45 min

Related resources:

Case studies:

Basic Account: € 146.00
Premium Account: € 110.00

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