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PRACTISE® Core

PRACTISE® Core 是 PRACTISE®課程的精髓，涵蓋研究者及研究中心人員必須知道的核心範疇。此課程包含整個PRACTISE®課程25個單元中的8個單元，合計只有5個課堂時數。

PRACTISE® Core 是 PRACTISE®课程的精髓，涵盖研究者及研究中心人员必须知道的核心范畴。此课程包含整个PRACTISE®课程25个单元中的8个单元，合计只有5个课堂时数。

PRACTISE® Core is the essence of the PRACTISE® program covering the core areas that investigators and study site personnel must know about. The program is composed of eight out of the 25 modules of the full PRACTISE® program, adding up to a total of only five lecture hours.

PRACTISE® Core 課程
單元編號 單元課題 建議時限(分鐘)
PRA-COM-1002 臨床研究的合規性 30
PRA-COM-1004 ICH GCP：概述和原則 30
PRA-COM-1005 ICH GCP：給研究者和研究中心工作人員的啟示 45
PRA-COM-1008 研究中心的質量管理 30
PRA-OPS-1002 知情同意：原則和實際考慮因素 60
PRA-OPS-1003 研究文件管理 45
PRA-OPS-1004 試驗用藥品管理 30
PRA-OPS-1006 安全管理和報告 30
PRACTISE® Core 课程
单元编号 单元课题 建议时限(分钟))
PRA-COM-1002 临床研究的合规性 30
PRA-COM-1004 ICH GCP：概述和原则 30
PRA-COM-1005 ICH GCP：给研究者和研究中心工作人员的启示 45
PRA-COM-1008 研究中心的质量管理 30
PRA-OPS-1002 知情同意：原则和实际考虑因素 60
PRA-OPS-1003 研究文件管理 45
PRA-OPS-1004 试验用药品管理 30
PRA-OPS-1006 安全管理和报告 30
PRACTISE® Core Program
Module No. Module Title Recommended
Duration (mins)
PRA-COM-1002 Clinical Research Compliance 30
PRA-COM-1004 ICH GCP: Overview & Principles 30
PRA-COM-1005 ICH GCP: Insight for Investigator & Study Site Personnel 45
PRA-COM-1008 Quality Management at Study Sites 30
PRA-OPS-1002 Informed Consent: Principles & Practical Considerations 60
PRA-OPS-1003 Study Document Management 45
PRA-OPS-1004 Investigational Product Management 30
PRA-OPS-1006 Safety Management & Reporting 30

PRACTISE® Core 符合TransCelerate BioPharma（由多家國際醫藥公司成立的非牟利單位，旨在協調藥物研究及開發的要求及慣例）對研究中心人員ICH GCP培訓之最低要求，以達致不同申辦者互認研究中心人員GCP培訓的目標。每位成功完成PRACTISE® Core 工作坊的參加者，將獲發一張獲TransCelerate成員公司認受的證書。

PRACTISE® Core符合TransCelerate BioPharma（由多家国际医药公司成立的非牟利单位，旨在协调药物研究及开发的要求及惯例）对研究中心人员ICH GCP培训之最低要求，以达致不同申办者互认研究中心人员GCP培训的目标。每位成功完成PRACTISE® Core工作坊的参加者，将获发一张获TransCelerate成员公司认受的证书。

PRACTISE® Core meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma (a non-profit organization established by a number of international pharmaceutical companies targeting for harmonization of requirements and practices in pharmaceutical research and development) as necessary to enable mutual recognition of GCP training among trial sponsors. Each participant successfully completed a PRACTISE® Core workshop will be issued a certificate acceptable to TransCelerate’s member companies.

重點
符合TransCelerate BioPharma對研究中心人員ICH GCP培訓之最低要求，以達致不同申辦者互認研究中心人員GCP培訓的目標
八個單元，涵蓋研究者及研究中心人員必須知道的核心範疇
如有需要，可提供實際個案研究、小組討論及測驗補充
導師擁有臨床研究管理及運作方面的實戰經驗
備有英文、普通話及廣東話三種語言
重点
符合TransCelerate BioPharma 对研究中心人员ICH GCP培训之最低要求，以达致不同申办者互认研究中心人员GCP培训的目标
八个单元，涵盖研究者及研究中心人员必须知道的核心范畴
如有需要，可提供实际个案研究、小组讨论及测验补充
导师拥有临床研究管理及运作方面的实战经验
备有英文、普通话及广东话三种语言
Highlights
Meeting the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors
Eight modules covering core areas that investigators and study site personnel must know about
Supplementary practical case studies, group discussions and quizzes are available if needed
Trainers with hands-on experience in clinical research management and operations
Available in three languages including English, Mandarin and Cantonese

在過去數年間，PRACTISE®課程或其個別單元已在亞洲、中東和北非地區，包括香港、澳門、台灣、中國大陸、馬來西亞、越南、阿拉伯聯合酋長國及埃及給相關的研究中心、研究機構、醫院及政府監管單位舉辦。該課程獲視為一個非常有效的培訓平台，並符合瞬息萬變的國際臨床試驗環境的最新規定。課程所提供的獨到觀點及見解都獲得培訓工作坊參加者的正面評價及肯定。

在过去数年间，PRACTISE®课程或其个别单元已在亚洲、中东和北非地区，包括香港、澳门、台湾、中国大陆、马来西亚、越南、阿拉伯联合酋长国及埃及给相关的研究中心、研究机构、医院及政府监管单位举办。该课程获视为一个非常有效的培训平台，并符合瞬息万变的国际临床试验环境的最新规定。课程所提供的独到观点及见解都获得培训工作坊参加者的正面评价及肯定。

Over the past few years, the PRACTISE® program or its individual modules have been delivered to various study sites, research institutions, hospitals and governmental organizations in Asia, Middle East and North Africa regions such as Hong Kong, Macau, Taiwan, mainland China, Malaysia, Vietnam, UAE and Egypt. It is regarded as a very effective training platform meeting the latest requirements in the rapidly changing international clinical trial environment. Its unique perspectives and insights have also gained very positive feedback and acknowledgement from workshop participants.

港大臨床試驗中心定期舉辦PRACTISE® Core 工作坊。如果你有興趣參加工作坊，請

港大临床试验中心定期举办PRACTISE® Core工作坊。如果你有兴趣参加工作坊，请

HKU-CTC runs the PRACTISE® Core workshop in regular basis. If you are interested in participate in the workshop, please

Thank you very much for your interest in PRACTISE®. Please spend a minute leaving your contact information in the following form, our staff should contact you where there is a PRACTISE® workshop.

Personal Information Collection (PIC) Statement

By submitting this form, you (i) express your interest in considering participation in the PRACTISE® Core workshop coordinated by HKU-CTC; (ii) agree HKU-CTC to keep, process and use your information for the purposes relating to your participation in the workshop; and (iii) agree HKU-CTC to contact you to participate in the workshop.

Your information provided under this section will be protected under the Personal Data (Privacy) Ordinance (“Ordinance”). Your information will be kept on a confidential basis by HKU-CTC, will be used only for the aforesaid purposes, and will not be disclosed to any third party without your prior consent. Under the Ordinance, you have the right to request access to and/or correction of your personal data. Any request should be made to HKU-CTC’s Personal Data Protection Coordinator (Email: pdpcctc@hku.hk; Tel: 2255 2550). If you have any question about your rights under the Ordinance, you may contact the Office of the Privacy Commissioner for Personal Data of Hong Kong.

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