Privacy Policy
With respect to the protection of personal information including the registration records of the Shinanokai Affiliated Clinical Study Volunteer Association and the health examination records and medical records of clinics operated by said Association, Medical Corporation Shinanokai complies with confidentiality obligations and other norms under the Personal Information Protection Act, guidelines for the handling of personal information in medical- and nursing care-related businesses, the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GPC-related laws, and certification laws. Medical Corporation Shinanokai has established, and implements and maintains, the following Policy for the Protection of Personal Information.
Overview of the Privacy Policy
- We will establish rules for handling personal data and implement them after ensuring that the Company employees and other relevant parties are fully aware of them, and we will improve and maintain them.
- Appropriate data security safeguards, such as measures against unauthorized access and computer viruses, shall be put in place to prevent the leakage, destruction, alteration, or loss of personal data.
- We will not only ensure that personal data is obtained through lawful and fair means, but also obtain consent from the data subject regarding the purpose of use.
- We recognize that the data subject has the right to request disclosure, correction, or suspension of the use of personal data and will respond to such requests from data subjects in accordance with our regulations.
- Personal data will not be disclosed or provided to a third party without the consent of the data subject unless required under the law. When providing personal data to business consignees, we will obligate them to protect personal data through confidentiality agreements and ensure that they handle it properly.
- The specific principles for collecting and handling personal data are defined below
Principle of Personal Data Usage
- Personal data shall only be used by authorized personnel within the scope of the purpose of collection as needed for the performance of specific duties.
Prohibited Acts- We will not use personal data beyond the scope of its intended purpose, remove it from its usual place of use, or leak personal data by sending it to external parties, etc.
- We will not disclose personal data obtained through business to a third party without just cause, nor shall we use it for unfair purposes. The same shall apply even after an employee has retired from the job in question, and we will take the measures necessary to ensure this.
- About the Handling of Anonymized Processed Information
We create "anonymized processed information" as stipulated in Article 2, Paragraph 9 of the Act on the Protection of Personal Information, and provide this information to third parties. We expect to continue the creation of similar anonymized processed information and its provision to third parties.
Items of information concerning individuals in anonymized processed information are as follows.
- Age, date of birth, gender, height, weight, and other physical data and information related to medical treatment (information on infirmities, therapies, treatments, tests, medication, clinic visits, clinic admission/discharge, etc.)
Methods by which anonymized processed information is provided to third parties are as follows.
- Sending via email
- CD-Sending via CD-ROM or other external storage media
- Upload to servers
Safety management measures, etc., for anonymized personal information
Shinanokai enacts necessary and appropriate measures for the prevention of leakage, loss, or damage of anonymized processed information and for other management of the safety of anonymized processed information.
Purposes of the use of personal information of Medical Corporation Shinanokai Clinical Trial Volunteer Association registrants and clinical study participants
| Personal information | Purpose of use by the Shinanokai Affiliated Clinical Study Volunteer Association, Shinanozaka Clinic, and Samoncho Clinic | Provision of information to other business operators, etc. |
|---|---|---|
| Volunteer registration records | Searching and selection of clinical study participant candidates Guidance concerning recruitment of participants for clinical studies, etc. (DM, telephone, email) Contact regarding scheduling of clinical studies, etc.(telephone, email) Contact regarding reexaminations(telephone, email) Contact in emergencies(telephone, email) Questionnaire surveys Information on events, seminars, campaigns, etc., organized by or related to Shinanokai |
Confirmation of study participation intervals and provision of study participation information to prevent duplicate registration (Japan Association of Contract Institutes for Clinical Pharmacology) Outsourcing of Clinical Trial Volunteer Association work (Tokyo Research Center of Clinical Pharmacology) |
| Treatment records, etc.(health examinations, clinical study records, etc.) | Searching and selection of clinical study participant candidates Reporting of health examination results (sealed and mailed to individuals' homes) Health consultations, specialist referrals Preparation of materials related to clinical studies, etc. Recording of examination data in clinical studies, etc. Preparation of case reports based on clinical study records |
Outsourcing of study subject recruitment work(Tokyo Research Center of Clinical Pharmacology) Outsourcing of assistance works for physicians in searching and selecting clinical study participation candidates(Tokyo Research Center of Clinical Pharmacology, etc.) Outsourcing of support work for physicians in charge of clinical studies (Tokyo Research Center of Clinical Pharmacology, etc.) Outsourcing of clinical examinations (SRL, etc.)* Outsourcing of medical examinations (other medical institutions, etc.)* Notification to attending physicians of participation in clinical studies (in cases of visits to other clinics) Submission of case reports to clinical study clients (pharmaceutical companies) (separate obtaining of consent)* Direct viewing of health examination records, study records, etc., by pharmaceutical companies, clinical study review committees, regulatory authorities, etc. Provision of treatment information to other clinics (referrals to other clinics) Presentations to academic societies, medical journals, etc. * |
| Other | Accounting administrative work involving cooperation expenses, reimbursement expenses, and awareness-building expenses | Outsourcing of accounting administrative work(Tokyo Research Center of Clinical Pharmacology) |
Purpose of use of personal information related to users of the Clinical Trial Volunteer Support Desk
- Examination and investigation of, and response to, the content of consultation, contact, etc.
- Confirmation of identity
Contact Information
Medical Corporation Shinanokai Clinical Trial Volunteer Association
Adress: Yotsuya Medical Building 3F, 20 Samoncho, Shinjuku-ku, Tokyo 1600017 Japan
e-mail: privacy@chi-ken.jp
2018.11.15
MEDICAL CORPORATION SHINANOKAI
Masami FUJITA, Chief Director