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PRACTISE® Core

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 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 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.

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

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.

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 4664). 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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