Recruitment Target Reached | 招募人數達標

Thank you for your interest in participating. Our current recruitment target has been reached.
感謝您對參與本研究的興趣,但目前的招募人數已達標。

 

COVID-19 Vaccines Adverse Events Response & Evaluation (CARE) Programme

COVID-19 is a global pandemic that affects people’s health and life. The COVID-19 vaccine is expected to play an important role in the control of the global pandemic. Hence, it is immensely important to closely monitor the safety of the vaccines as they begin to be taken up by the citizens of Hong Kong. A comprehensive post-marketing surveillance is needed to monitor for potential adverse events of COVID-19 vaccines while in widespread clinical use.

The CARE Programme is a comprehensive surveillance programme that closely monitor known and potential adverse events of COVID-19 vaccines. It aims to ascertain details of adverse events to inform the public in a timely manner. The HKU Department of Pharmacology and Pharmacy team is responsible for implementing the CARE Programme.

We are now inviting the COVID-19 vaccination priority groups to participate in our study. Your participation will allow researchers to build a better understanding of the vaccine, to promote and support future vaccination studies. We can work together to fight against the pandemic.

2019冠狀病毒病疫苗安全監測計劃(新冠疫苗監測計劃/CARE)

2019冠狀病毒病是影響人們健康和生活的全球大流行的病毒。2019冠狀病毒病疫苗預計將在控制全球大流行中發揮重要作用。因此,在香港市民開始接種2019冠狀病毒病疫苗的同時,密切監測疫苗的安全性至關重要。全面的疫苗上巿後監測機制可以觀察到疫苗廣泛使用後的潛在異常事件。

香港大學2019冠狀病毒病疫苗安全監測計劃(CARE)是一套完善的2019冠狀病毒病疫苗安全監測機制,嚴密監測各類2019冠狀病毒疫苗已知及潛在的的異常事件,確定所有異常事件的詳細信息,並將這一監測結果及時向社會公眾公佈。此監測計劃是由香港大學藥理及藥劑學系團隊負責實行。

研究團隊誠邀首批優先接種2019冠狀病毒病疫苗的人士積極參與研究計劃, 協助研究團隊吸取經驗, 推展日後疫苗接種, 齊心打贏抗疫戰。

Purpose | 研究目的

This study aims to understand the potential adverse events seen in people of different age groups and their health statuses following COVID-19 vaccination. This study will be conducted in the form of follow-up surveys.

是次研究旨在了解不同年齡層及健康狀態的人士在接種2019冠狀病毒病疫苗後的疑似異常事件,並以問卷方式作調查。

Content | 研究內容

Each vaccine recipient or caregiver will complete a set of online or paper survey 1,2,3,7, 14,28 day(s) after each COVID-19 vaccine injection (2 doses in total).

The surveys will record the health status and any adverse events seen in the vaccine recipient.

疫苗接種者或其照顧者在每次疫苗接種(共兩劑)後的第 1、2、3、7、14和28天,填寫最多12份電子或實體問卷。

問卷將記錄接種者的健康狀況及疑似異常事件。

Participation Eligibility | 參與者資格

You/Your ward will be eligible to participate in this study if you/your ward is a Hong Kong resident and have received COVID-19 vaccines.

若您/您的受監護者是香港居民,並接種了2019冠狀病毒病疫苗,便合乎參與本計劃的資格。

Remuneration | 研究津貼

As a token of appreciation, each vaccine recipient/caregiver will receive a HK$50 gift voucher upon completion of all surveys for the 1st dose, and a HK$100 gift voucher upon completion of all surveys for the 2nd dose.

為答謝參與計劃的接種者或其照顧者,完成第一劑疫苗問卷後,可獲港幣50元禮券;第二劑疫苗問卷後,可獲港幣100元禮券。

Data Collection | 個人資料收集

What kind of personal data is collected? 哪些個人資料將會被收集?

  • De-identified individual information, demographic information and vaccination records (such as vaccination date, type of vaccine, batch number and vaccination location).
  • 去識别化個人資料、人口統計學資料、以及疫苗接種紀錄(包括接種日期,疫苗類型、批號以及接種地點等)將會被收集。

What kind of clinical data is collected? 哪些臨床資料將會被收集?

  • Known and potential adverse events after receiving the COVID-19 vaccines and the relevant data such as diagnostic records and laboratory data from the hospitals will be collected.
  • 接種2019冠狀病毒病疫苗後已知及潛在的異常事件及其相關資料將會被收集,例如來自醫院的診斷紀錄和實驗室資料。

Why is such data collected? 收集上述資料的目的是什麼?

  • Your personal data will be collected to ascertain your COVID-19 vaccination status and your clinical data will be collected to investigate the association between any adverse events and the COVID-19 vaccines. It is immensely important to collect the data to conduct the surveillance to identify any adverse events following immunisation and inform the public in a timely manner.
  • 個人資料的收集是為了確定您2019冠狀病毒病疫苗的接種情況;臨床資料的收集則是為了確定接種2019冠狀病毒病疫苗後的異常事件的發生以及與疫苗接種的相關性。收集以上資料進行接種疫苗後的異常事件的監測並及時向社會公眾公佈至關重要。

How will the collected data be handled? 收集上述資料後將如何處理?

  • All data will be entered into electronic databases and destroyed as per usual practice after conclusion of the surveillance. All personal and clinical data will be anonymised and kept confidential. No personal identifier will be reported in the reporting of analysis.
  • 所有的資料將會記錄於電子資料庫中,並在監測項目結束後按照慣例進行銷毀。所有收集的個人和臨床資料將會被去識别化及絕對保密,分析結果中也不會包含和暴露任何可識別的個人資料。
Confidentiality | 資料保密

All data and original documents will be stored in the Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, the University of Hong Kong. Original documents will be entered into electronic databases and destroyed 5 years after the conclusion of the study. All personal data will be kept confidential and the data for data analysis would be anonymised. Your/Your ward’s data and information may be inspected by regulatory authorities of academic research, such as auditor(s) or the Institutional Review Board/ Independent Ethics Committee.

Under the laws of Hong Kong (in particular the Personal Data (Privacy) Ordinance, Cap 486), you/your ward enjoy or may enjoy rights for the protection of the confidentiality of your/your ward’s personal data, such as those regarding the collection, custody, retention, management, control, use (including analysis or comparison), transfer in or out of Hong Kong, non-disclosure, erasure and/or in any way dealing with or disposing of any of your/your ward’s personal data in or for this study. For any query, you should consult the Privacy Commissioner for Personal Data or his office ( +852 2827 2827) as to the proper monitoring or supervision of your personal data protection so that your full awareness and understanding of the significance of compliance with the law governing privacy data is assured.

By consenting to participate in this study, you expressly authorise:

  • the principal investigator and his research team and the ethics committee responsible for overseeing this study to get access to, to use, and to retain your/your ward’s personal data for the purposes and in the manner described in this informed consent process; and
  • the relevant government agencies (e.g. the Hong Kong Department of Health) to get access to your/your ward’s personal data for the purposes of checking and verifying the integrity of study data and assessing compliance with the study protocol and relevant requirements.

所有數據和正本文件將會儲放在香港大學李嘉誠醫學院藥理及藥劑學系內。研究人員會將所有正本文件的資料輸入電子數據庫,並會在研究結束5年後銷毀所有正本文件。所有個人資料將絕對保密,研究人員會以不記名方式作數據分析。學術研究的監管機構,例如審計師或者研究倫理委員會,亦有可能檢閱您您的受監護者的數據和資料。

根據香港法律(特別是「個人資料(私隱)條例」第486章),您有權對您/您的受監護者的個人資料進行保密,如在本項研究中或與本項研究有關的個人資料的收集、保管、保留、管理、控制、使用(分析或比較)、在香港內外轉讓、不披露、消除和/或任何處理方式。如有任何問題,您可以諮詢個人資料私隱專員或致電到其辦公室( +852 2827 2827),以適當監管或監督您/您的受監護者個人資料的保護,以便您能完全認識和瞭解確保遵守法律保護隱資料的意義。

同意參與本項研究,即表示您明確作出以下授權:

  • 為了監督該項研究,授權主要研究者及其研究團隊和倫理委員根據本項研究和本知情同意書規定的方式獲得、使用並保留您/您的受監護者的個人資料,並且
  • 為了檢查和核實研究資料的完整性、評估研究方案與相關要求的一致性,授權相關的政府機構(如香港衞生署)可獲得您/您的受監護者的個人資料。
Publication of Findings | 結果發表

After the completion of the study, we will publish the research findings in medical journals or share anonymised data with other academic institutions. We may also publicise the findings through the local and international media. Under no circumstances would any personal data be released. The data collected in this study maybe analysed in other related studies that we may conduct in future.

研究結束後,我們會將研究結果透過醫學期刊發表,或會把數據以匿名方式與其他學術團體共享,亦可能會舉行新聞發佈會向本地和國際媒體發表我們的研究成果。但是在任何情況下將不會透露您/您的受監護者的個人身份。此外,研究人員或會將這項研究的所有收集到的數據用於未來相關研究的數據分析中。

Enquiries | 聯絡研究團隊

For any enquiries, please contact our research personnel Ms Leung:

如有查詢,請聯絡:

+852 2831 5110
carehk@hku.hk