肝友營會員登記及同意書  Liver Care Group Membership Registration and Consent Form
*必須填寫 (所有個人資料,僅供內部使用)
*Mandatory field (Personal information for internal use only)
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計劃名稱:「肝友營」會員計劃
Programme Name: "Liver Care Group" Programme

計劃之廠商:香港大塚製藥有限公司 (以下簡稱"香港大塚")
Programme Company: Otsuka Pharmaceutical (H.K.) Ltd. (hereinafter referred to as "HKOP")

第三方執行單位:明途聯繫有限公司
Third Party Executing Company: MentalCare Connect Company Limited
參加者姓名 Name of Registrant *
性別 Gender *
年齡 Age *
郵寄地址 Mailing address *
手提電話 Mobile number *
電郵 Email address
同意接收資訊途徑
Consent to receive information through the following channel(s)
*
Required
第三方執行單位先徵詢並取得您的同意後,已向您解說本計劃內容及對您相關權益的保障。請務必詳細閱讀本同意書所有內容。 
The third-party executing company has consulted with you and obtained your consent. They have explained the details of this programme to you and the protections of your relevant rights. Please read all the contents of this consent form carefully. 
我瞭解及同意如下安排:
  • 參與本計劃屬自願性質,我可以拒絕或隨時退出本計劃,並不會影響我接受醫療之權益。
  • 香港大塚可以隨時提前終止本計劃。
  • 本同意書所記載之個人資料,僅供本計劃使用,且會被保密,由第三方執行單位保存,不會向第三者(包括香港大塚)揭露或轉介,而我的身份將會以一個編號代表。個人資料包括監護人及本計劃參加者的個人資料。我亦可以隨時聯絡第三方執行單位,要求查閱、改正或刪除我的個人資料。
  • 我的個人資料會在本計劃執行完畢,或我退出本計劃後,從本計劃資料庫中刪除。與我相關資料將會以匿名方式保留在資料庫。
  • 於本計劃期間,如我有陳述任何與“ 肝美靈®”相關之不良事件發生時,第三方執行單位會向香港大塚進行通報,以維持風險及效益之持續管理。
香港大塚會根據衛生署藥物辦公室指引蒐集及取得有關“肝美靈®”不良事件之相關細節進行通報,以符合其法定義務。香港大塚對於與我有關之不良事件通報記錄,會予以嚴格保密,除了香港大塚藥物安全部門,或授權處理安全性資料之廠商,香港大塚不會提供或披露我的不良事件通報記錄予第三人。
I understand and agree to the following:
  • Participation in this programme is voluntary. I can refuse or withdraw from the programme at any time without affecting my right to receive medical care. 
  • HKOP can terminate this programme at any time.
  • The personal information recorded in this consent form is only for use in this programme and will be kept confidential. It will be maintained by the third-party executing company and will not be disclosed or transferred to any third party (including HKOP). My identity will be represented by a code number. The personal information includes that of the guardian and the participant in this programme. I can also contact the third-party executing company at any time to request access, correction, or deletion of my personal information. 
  • My personal information will be deleted from the programme database upon completion of the programme or my withdrawal. However, my anonymized information may be retained in the database. 
  • During the programme, if I report any adverse events related to "Aminoleban® EN", the third-party executing company will notify HKOP to maintain ongoing risk and benefit management. 
HKOP would follow guidelines from Drug Office, Department of Health to collect and obtain details of the adverse events related to "Aminoleban® EN" in order to fulfill its legal obligations for reporting. HKOP will maintain strict confidentiality of my adverse event reporting records and will not provide or disclose my adverse event reporting records to any third party, except to Otsuka's drug safety department or their authorized vendors for handling safety data.
徵詢參加者陳述之"肝美靈®"不良事件後續追蹤意向
第三方執行單位已告知我,相關資訊將會送至香港大塚,
Inquiring about the participant's intention for follow-up on reported "Aminoleban® EN" adverse events:
The third-party executing company has informed me that the relevant information will be sent to HKOP.
*
參加者或監護人確認
Confirmation by Participant or Guardian
我已詳細瞭解上述同意書所有內容,確認本計劃只屬肝臟健康及支鏈氨基酸(BCAA)資料分享小組,並不涉及任何治療方案。有關本計劃的疑問,可與第三方執行單位聯絡。
I have carefully read and understood all the contents of the above consent form. I confirm that this programme is only an information-sharing group for liver health and branched-chain amino acids (BCAA) and does not involve any treatment plan. For any questions about this programme, I can contact the third-party executing company. 
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