Course Introduction and Objective:
Welcome to ERT’s eCOA Basics course! Dive into 6 lessons that answer 3 basic questions:
- What is eCOA?
- Why use eCOA?
- When to use eCOA?
The overarching goal of this course is to equip you with a foundational understanding of electronic clinical outcome assessments (eCOA). We want you to be able to interpret and discuss when and why it is important to use eCOA in clinical trials.
Approximately 45 minutes, self-paced.
Includes knowledge checks within the material and a cumulative quiz for self-reflection.
Topic 1: What is eCOA?
1.1: What are COA and eCOA?
This content is beneficial to you if you desire to define COA and eCOA and understand the different types of COA and eCOA.
1.2: Technology Options for Implementing eCOA
This section identifies technology options for eCOA and explains scenarios in which they are typically implemented.
Topic 2: Why use eCOA?
2.1: Benefits for the Sponsor
This section dispels common myths you may have heard about using eCOA and outlines 5 key reasons why eCOA can improve data quality in clinical trials.
2.2: Benefits for Sites and Patients
This section outlines some advantages eCOA has over paper COA from the perspective of study site personnel and patients, and discusses why Patient-Reported Outcomes (PROs) are important to the patient.
2.3: Regulatory Perspective
This content is beneficial to you if you are interested in learning about eCOA recommendations from regulatory agencies, such as the FDA and EMA.
Topic 3: When to use eCOA?
3: When is it most critical to use eCOA?
Whether it is for better compliance, increased data accuracy, or a better user experience, this section outlines key scenarios when using eCOA is most critical.
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