Clinical Trials Guide
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Rules of Clinical Trials
Clinical trials are conducted in compliance with the Pharmaceutical Affairs Law, its enforcement ordinance, its enforcement regulations, the GCP*1 ministerial ordinance and related notifications, and the clinical trial protocol*2.
Comply with ethical principles based on the Declaration of Helsinki
We will weigh the expected benefits of a clinical trial for the participants (subjects) and society against the expected risks and inconveniences and will initiate and continue a clinical trial only when the expected benefits justify the risks taken. Consideration of human rights, safety and welfare will take precedence over the benefits to science and society.
That the clinical trial must be scientifically valid.
For investigational drugs, sufficient information on non-clinical and clinical trials is available to support the conduct of the clinical trial. The investigator is always responsible for the medical care and medical decisions for the participants (subjects) in a clinical trial.
GCP（Good Clinical Practice）
The "Ministerial Ordinance on Standards for Conducting Clinical Trials on Drugs" is a regulation that is recognized internationally, including in Europe and the United States.
*2Clinical Trial Protocol
The protocol clearly and in detail describes the details of the clinical trial (dosage of the investigational drug, test items, timing of implementation, etc.). The protocol agreed upon by the pharmaceutical company and the investigator must be submitted to the MHLW and must be reviewed and approved in advance by the IRB*3.
*3IRB (Institutional Review Board)
The IRB is an organization that examines the appropriateness of the protocol and the explanatory documents for the participants (subjects) of the clinical trial from scientific and ethical viewpoints, and the head of the institution must comply with the opinions of the IRB, The IRB is composed of medical and pharmaceutical experts as well as non-specialists (e.g., lawyers, science and engineering experts, etc.). In addition, the IRB must include persons who have no vested interest in the site or investigator. For more information on the members of the IRB, please click here.