Volunteer Association Pledge
This is a portion of the pledge we ask you to agree before joining.
I agree with the spirit of the Association, have read and understood the terms below, and pledge to follow the terms when registering to the Association.
I wish to contribute to the development of Japanese medicine and pharmacology through participation in clinical trials.
I will not make false declarations when registering to the Association or participating in clinical trials.
I will declare accurate clinical information regarding items listed on the volunteer card, medical history, food/drug allergies, health condition, and any medications I am taking.
I will not participate in multiple clinical trials simultaneously. I consent to being verified against the Japan Association of Contract Institutes for Clinical Pharmacology to confirm that I am not participating in duplicate clinical trials. (Verification items: name and date of birth)
I will not disclose any information obtained during the clinical trial to a third party, including personal information of other volunteers or information on the drug being investigated.
I acknowledge that whether I am allowed to participate in a clinical trial is the decision of the principal investigator or sub-investigator ("the Investigator") and will abide by the Investigator's decision.
I will also abide by the rules of the medical facility and staff instructions, cooperate in the proper conduct of the trial, and refrain from behavior that would cause a nuisance to others.
I will not object if my registration with the Association is canceled or my clinical trial participation is revoked due to false declarations, duplicate participation in clinical trials, or other actions that cause a nuisance to Medical Corporate Shinanokai, its affiliated medical institutions, or trial sponsors (pharmaceutical companies, etc.).
I understand that participating in clinical trials is not a form of employment to obtain income and that trials may be discontinued, postponed, or terminated before or during the trial.
I understand that no monetary or other compensation will be provided if a scheduled trial is discontinued, postponed, or terminated, and will not claim compensation.
Cases of trial discontinuation:
・ When my participation is discontinued or deemed impossible by the Investigator
・ When the trial itself is discontinued due to circumstances at the pharmaceutical company, etc.
・ When the required number of cases is attained and the trial ends immediately
・ When the trial cannot be conducted due to a natural disaster, etc.
・ When arrival at the clinic is impossible due to transportation delays, etc.
Additional Information
Drug studies are clinical trials conducted to obtain approval under the Pharmaceutical Affairs Law for the manufacture and sale of pharmaceuticals.
These studies involve both the research aspect of new drug development and the corporate aspect of product development.
Therefore, if the necessary data and accurate assessments (safety, efficacy, etc.) cannot be obtained due to uncooperative behavior on the part of the subject such as false declarations or duplicate participation with other facilities, this may result in damages, such as having to conduct an additional unplanned trials.
Depending on the circumstances, those who engage in uncooperative behavior may be held liable for damages.
You will also be unable to receive proper compensation for any health problems stemming from such behavior.
We ask that you fully understand what a clinical trial is based on the information above before applying.