Investigational products

↳ This is a section part of Moment: Good Clinical Practice (GCP)

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Summary

Add this Moment to your Passport

Learn from this moment and keep it forever.
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$59.99
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Simple Premium offers unlimited access to all premium moments. $30.00 per month. Cancel anytime.

Target Audience

  • Healthcare professionals working in clinical trials

Learning Objectives

  • Become component with the requirements of GCP

Other Components in this Moment

Overview
What is GCP?
The 13 principles of ICH-GCP
What is the purpose of GCP?
Investigator qualifications and agreements
Adequacy of resources
Medical care of trial participants
Communication with the IRB/IEC
Compliance with the protocol
Investigational products
Randomisation and unblinding procedures
Informed consent
Informed consent cont.
Informed consent - required elements
Records and reports
Progress reports to sponsor/IRB/IEC
Safety reporting
Premature termination or suspension of a study
Premature termination or suspension of a study cont.
Consequences of GCP non-compliance
Applying GCP to your study
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