Course Description

GCP for Investigators: Clinical Investigation Conduct and Reporting

Course Description:

This course reviews important elements for conducting clinical investigations.

It covers the following topics:

  • Effective team–sponsor communication to ensure compliance
  • Investigator involvement during monitoring visits
  • The informed consent process
  • The device accountability process
  • Data and other study-related requirements
  • Reporting

The content of is course is based on:

  • ISO 14155: 2020 Clinical Investigation of Medical Devices for Human Subjects
  • The Declaration of Helsinki
  • 21 CRF 812: Investigational Device Exemption
  • 21 CRF 50: Protection of Human Subjects

Learning Objectives:

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

  • Identify and apply effective methods to keep sites in compliance during clinical investigations

Who Should Enroll:

Principal and co-investigators, study coordinators, site managers, and hospital or ancillary staff involved in the clinical side of medical device clinical investigations are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • GCP for Investigators: Introduction to Medical Devices (ID 193)
  • GCP for Investigators: How to Qualify for Medical Device Clinical Investigations (ID 200)
  • GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations (ID 212)

Subject Matter Expert:
Danielle Giroud

51 min

Related resources:

Case studies:

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