GCP for Investigators: Clinical Investigation Conduct and Reporting

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GCP for Investigators: Clinical Investigation Conduct and Reporting

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

ID: 204

51 minutes

2 modules

€ 128.00
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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

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)