Handling of Personal Information Related to Clinical Trials

In accordance with the enforcement of the Personal Information Protection Law (Act on the Protection of Personal Information), Medical Corporation HOUEIKAI has established the following privacy policy.

Personal Information Protection Policy

Medical Corporation HOUEIKAI recognizes the importance of personal information and believes that it is our social responsibility to use, provide, and manage such information appropriately, as well as to thoroughly protect it. All staff members will comply with this policy and make every effort to protect personal information.

• 1.Compliance with Laws and Regulations

  Medical Corporation HOUEIKAI will comply with the Personal Information Protection Law, other related laws and regulations, guidelines established by the government, and other norms.

• 2.Specification and Publication of Purpose of Use and Items of Personal Information

  Medical Corporation HOUEIKAI will establish the necessary rules regarding the handling of personal information and systems and will maintain an organization with an administrator to ensure compliance with personal information protection.

  Purpose of Use

  1)Application for approval to the MHLW
  2)Inquiry the Japan Association of Contract Institutes for Clinical Pharmacology
  Details ： Name, date of birth, administration history of investigational drug
  Purpose ： drug withdrawal period and enrollment confirmation at member clinics
  Scope ： The Japan Association of Contract Institutes for Clinical Pharmacology and its member clinics
  3)Determination of enrollment at our clinic
  4)Determination of participation in clinical trials
  5)Notification of various results
  6)Notification of clinical trial schedule
  7)Set and review of reference values for our clinic
  8)Transfer of burden reduction expenses
  9)Making management card in our clinic
  10)Reference for recruiting work
  11)Confirmation of referrals
  12)Other emergency contacts

  Items to be used (* indicates required)

  1)Name *
  2)Date of birth *
  3)Address
  4)Phone number *
  5)Bank account number
  6)Previous and current medical history *
  7)Height, weight and other data *
  8)Results of physical examination (interview, examination details, clinical laboratory values, etc.) *
  9)Photograph of the applicant's face
  10)E-mail address
  11)History of investigational drug administration *

• 3. Appropriate Acquisition

  Medical Corporation HOEIKAI will acquire personal information in an appropriate and fair manner within the scope necessary to achieve the purpose. We will never acquire personal information through deception or other wrongful means.

• 4.Limitations on the Purpose of Use

  Medical Corporation HOUEIKAI will handle personal information appropriately within the scope necessary to achieve the purpose. We will never use personal information beyond the scope of the purpose, except as stipulated by law.

• 5.Ensuring Accuracy of Data Contents

  Medical Corporation HOUEIKAI will make every effort to keep personal data accurate and up-to-date to the extent necessary to achieve the purpose.

• 6.Safety Management Measures

  Medical Corporation HOUEIKAI will strive to ensure the safety of personal information by taking and implementing necessary and appropriate safety measures to prevent and correct unauthorized access, falsification, loss, leakage, etc. of personal information.

  Technical Safety Control Measures

  1)Access control to personal information (limitation of access authority)
  2)Regular data backup and server maintenance
  3)Measures to prevent information leakage (limitation of writing on recording media)
  4)Measures to prevent unauthorized access from outside

  Physical security control measures

  1)Restrictions on areas where personal information is handled
  2)ID card inventory control
  3)Entering/Leaving control of areas where personal information is handled

• 7.Supervision of Employees and Contractors

  Medical Corporation HOUEIKAI will exercise necessary and appropriate supervision over employees who handle personal information to ensure the safe management of personal information. In addition, Medical Corporation HOUEIKAI will not outsource the handling of personal information.

• 8.Restrictions on Provision to Third Parties

  Medical Corporation HOUEIKAI may provide acquired personal information to third parties for the purpose of applying for approval from the MHLW, making inquiries to the Association for Clinical Trial Services, etc., after obtaining prior consent from the person concerned. However, we will never provide personal information to a third party without the consent of the individual, except as stipulated by law.

• 9.Disclosure, Correction, Suspension of Use, etc. of Personal Information

  Medical Corporation HOUEIKAI has established the following procedures for requests from individuals to disclose, correct, delete, or discontinue the use of their personal information that we have obtained.

  Public Announcement of Purpose of Use of Personal Information

  Except as otherwise provided by law, we will make the information available to you in question and respond to your request without delay.

  Disclosure of Personal Information

  The registered information is accessible through "My Page", which allows you to confirm or correct your e-mail address, phone number, address, password, etc. Only the information of the individual can be accessed from "My Page". If you request disclosure of personal information that cannot be accessed from "My Page," we will respond to your request without delay to the extent reasonable and necessary, except as otherwise required by law.

  Correction, Addition, or Deletion of personal information

  If you request us to correct, add, or delete any item of personal information that is not available on "My Page" because it is untrue, we will promptly investigate the matter and, based on the results, correct, add, or delete the personal information within the scope necessary to achieve the purpose, except as otherwise required by law. Then we will notify you to that effect.

  Suspension of Use of Personal Information

  If you request us to stop using or delete your personal information on the grounds that it has been handled in a manner that exceeds the scope of the purposes for which it was disclosed to you in advance or that it was obtained through wrongful means, we will promptly investigate, except as otherwise required by law, and based on the results of that investigation, stop using or delete your personal information. Then we will notify you to that effect.

  Cessation of Provision of Personal Information to Third Parties

  When you request us to stop providing your personal information to a third party on the grounds that such information is being provided to a third party without your consent, we will promptly investigate and, based on the results of the investigation, stop providing the personal information to the third party, except as otherwise provided by law. Then we will notify you to that effect.
  In some cases, we may not be able to respond to a request for non-disclosure, correction, deletion, suspension of use, etc. as specified above due to reasons stipulated by law (e.g., when there is a risk of harm to the life, property, or other rights or interests of you or a third party, when there is a violation of other laws or regulations, or when special procedures are stipulated by law, etc.). In such cases, we will notify you of our inability to respond and explain the reason to the best of our ability.

• 10.Review of Regulations

  Medical Corporation HOUEIKAI will continuously review, improve, and enhance its management regulations and organizational structure regarding personal information to ensure that they are effective and appropriate.

• 11. Inquiries regarding opinions or consultation

  If you have any comments or inquiries regarding the handling of personal information in clinical trials conducted by Medical Corporation HOUEIKAI, please contact us by filling out the designated form in the "Contact Us" section. If you wish to contact us by phone or e-mail, please refer the below. At that time, we may ask you questions such as your name and date of birth to confirm your identity.