ICH E-6 Protocol Guidelines: A Comprehensive Overview

ICH E-6 is a guideline established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and adopted in the U.S., Europe and Japan. It outlines the expected responsibilities of parties involved in the conducting of clinical trials.

Background

• Information on the product to be studied must be clearly documented. This includes name, description, risks, benefits, dosage information, reference literature and description of the population being studied.

Parameters

• The objective, purpose and design of the trial must be clearly outlined, including details on procedures and stages, means of minimizing bias, expected duration and rules for discontinuing the trial.

Subjects

• All study subjects must be treated according to the guidelines determined in the design model. The criteria used to determine the inclusion or exclusion of subjects must be clearly explained. Any withdrawal from the study must show when and why they left the study, as well as whether they will be replaced. Follow-ups should be performed on all withdrawn subjects.

Evaluation

• Assessments must be regularly performed on the safety and efficacy of the procedures, specifying parameters, documenting methods and timing.