Intermediate Medical Writing: Investigational Applications




  • At A Glance
  • Learning Objectives
  • Lesson Title
  • Registration Options

At A Glance

  • Target Audience: This course is intended for Professionals with one to three years’ experience in medical writing and those who need a basic introduction to the regulatory documents discussed.
  • Learning Level: Basic
  • Total Length of Course: 6–12 Hours
  • RAC Credits: 6
  • Cost: Member $550; List $770
  • Format: PC and Tablet (iPad and Android)
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    View the RAPS Online University FAQs.

Learning Objectives

Upon completion of this course, participants should be able to:

  • Determine the most appropriate IND required for a clinical trial involving an investigational new drug/biologic in the US and discuss the regulatory process for IND submission, review and update.
  • Determine when an IDE application is required for a clinical trial involving an investigational medical device in the US, describe the structure and content needed to prepare an IDE submission and discuss the regulatory requirements in the case of changes to investigational device or protocol during the conduct of an IDE study
  • Discuss the formal and informal options available to communicate with the US Food and Drug Administration (FDA) prior to/during IDE submission
  • Determine when a CTA is required for a clinical trial involving an investigational new drug/biologic in Canada and discuss the regulatory process for CTA and CTA-A submission and review, including the value of Pre-CTA consultation meeting(s)
  • Determine when an ITA application is required for a clinical trial involving an investigational medical device in Canada and describe the structure and content needed to prepare an ITA submission.
  • Discuss when and how to approach Health Canada for pre-submission consultation prior to submitting an ITA and determine regulatory requirements in the case of changes to investigational device or protocol during the conduct of an ITA study.
  • Explain and summarize the data requirements for writing the IMPD.
  • Outline and describe the core documentation required to submit a clinical trial application (CTA) in Europe.

Lesson Title

  • Lesson 1: Investigational New Drug Application (IND)
  • Lesson 2: Investigational Device Exemptions (IDE)
  • Lesson 3: Canadian Clinical Trial Application
  • Lesson 4: Investigational Testing Authorization (ITA)
  • Lesson 5: Investigational Medicinal Product Dossier (IMPD)
  • Lesson 6: European Clinical Trial Application

Registration Options

This course is available for purchase as follows: