Decision on the issuance of guidelines on recognition, management and reporting of serious adverse events in the Clinical Trials in Vietnam
Updated on the 26 of June, 2017
On the 2nd of June 2017, Ministry of science and technology issued Decision 62/QĐ-K2ĐT on the issuance of "Guidance on recognition, management and reporting of serious adverse events in the Clinical Trials in Vietnam".
Pursuant to law pharmacological on April 5th, 2016
Pursuant to Decree No. 63/2012/ND-CP of Government on August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health.
Pursuant to the Health Minister's Decision no 4059/QD-BYT on October 22 , 2012 defining the functions, tasks, powers and organizational structure of Ministry of science and technology.
Issued together with this decision “guidelines on recognition, management and reporting of serious adverse events in the Clinical Trials in Vietnam”. Guidelines include:
1. General principles
2. Definition and classification
3. AE/SAE reporting in the Clinical Trials in Vietnam
4. Handle AE/SAE in the Clinical Trials in Vietnam
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