Quality Data...Delivered by Design™

Quality Data...Delivered by Design™



Good Clinical Practices for the Clinical Investigator

Price: $99 +S&H

This book is a self-study course presented in a workbook format. It is designed to train the Clinical Investigator on the fundamental FDA regulations and Good Clinical Practice Guidelines.

The Workbook includes all reference materials needed for a physician to further research each presented topic. Each chapter includes a self-evaluation test.

Readers will gain knowledge of the key activities required to:
  • Conduct and manage clinical research studies effectively
  • Protect human subject safety and welfare
  • Comply with FDA regulations and Guidelines
Readers will be able to:
  • List the FDA and ICH Good Clinical Practice Requirements for clinical research
  • Describe how these requirements affect their daily activities to protect human subject safety, rights and welfare
  • Identify the roles and responsibilities of the Principal Investigator and all supporting research team members
Self-Study Modules include:
  • Roles and Responsibilities
  • Financial Disclosure Requirements
  • Human Subject Protection: Informed Consent
  • Adverse Event Reporting
  • Test Article Accountability
  • Study Documentation
Good Clinical Practices for the Clinical Investigator

This book is a self-study course presented in a workbook format. It is designed to train the Clinical Investigator on the fundamental FDA regulations and Good Clinical Practice Guidelines.

Price: $99 + S&H

Contact us at 585-381-1350 x246 for more information.