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
|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.
|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.