4. Things to be observed by participants in clinical trials
Things to be observed by participants in clinical trials to ensure their safety and to collect reliable data
In order to ensure safety and collect reliable data, there are certain things that patients participating in a clinical trial must observe during the trial. The details are described in the explanatory document handed to the patient at the time of informed consent.
General precautions
How to take investigational drugs, tests, etc.
- Please follow exactly the method, duration, and frequency of taking the study medication.
- Please be sure to return any treatment drugs that you do not use, as they are not yet government-approved medications.
Precautions for daily life
Depending on the nature of the clinical trial and the type of disease, there may be restrictions on diet, exercise, alcohol consumption, smoking, etc.
When receiving other hospitals or taking other medications
If you are going to visit another hospital or take a new medication (including over-the-counter or herbal medicines), please consult with the doctor in charge of the clinical trial in advance. Combining an investigational drug with another drug may cause unexpected effects, such as weakening or strengthening the effects of each.
Precautions in case of any change in your physical condition
If you start using an investigational drug and notice unusual symptoms, contact your physician immediately.