Course Description

Conducting studies using Electronic Data Capture

Course Description:

This course introduces Electronic Data Capture (EDC), a method used to collect and deliver clinical trial data to sponsors in electronic form. Its objective is to reduce clinical data errors, increase the efficiency of communication between sponsors and investigators, and ultimately reduce the time needed to deliver regulatory submissions. This course provides comprehensive and expert recommendations to put EDC processes in place and to ensure ongoing effective management.

This course is based on the ISO 14155: 2011 and 21 CFR 11 requirements. It provides a detailed overview of the processes, roles, and responsibilities needed to implement EDC in clinical studies, as well as which pitfalls to avoid and what factors to consider when selecting an EDC vendor.

Learning Objectives:

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

  • Define and demonstrate the basic principles and objectives of conducting studies using EDC
  • Identify the roles, responsibilities, and processes involved in clinical studies using EDC
  • Assess and select successful EDC vendors

Who Should Enroll:

Clinical project managers and directors, data managers, biostatisticians, and quality assurance managers involved in vendor selection and compliance with applicable laws and standards are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Overview of Data Management Plan and Query Process (ID 108)

Subject Matter Expert:
Melody Lashlee

30 min

Related resources:

Case studies:

Basic Account: € 100.00
Premium Account: € 76.00

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