Year Published: 2024

Time to Complete: 25 min

Course Type: Self-paced Online

Instructor: Vidya Iyer, MBBS

Learning Level: Fundamental

Primary Audience: All Research Team Members

Prerequisite: None

Course Collection(s): Clinical Research Operations

Are you utilizing best practices when completing regulatory documents?

This self-paced course highlights best practices for completing and managing regulatory documents for industry-funded clinical trials. It provides an overview of the regulatory documents that are required before study initiation and best practices for completing them. You will also learn strategies for keeping a well-organized digital regulatory binder alongside the physical study binder.

Learning Objectives

After completing this course, you will be able to:

  • Identify the required documents for study start-up.
  • Distinguish between FDA-required and sponsor-specific forms.
  • Discuss tips and tricks for completing regulatory documents.
  • Utilize best practices for organizing regulatory forms in digital format (“Regulatory Binder”).

 

Available courses

Date Location Type Price
2024 Course: Open January 1 through December 31 Online Self-paced course This Course is Free

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