Drug safety evaluation in clinical trial
CAO Ye
WAN Bang-xi
Abstract：Drug safety evaluation is an activity throughout new drug pre-clinical research,clinical trials and post marketing reevaluation.In clinical trials,although the collection,recording and evaluation of drug safety information is mainly performed by investigator teams,the protocol and detailed implementation rules drafted by the project sponsors are also the key factors to ensure the high quality of information collection and evaluation etc.It is considered that safety evaluation relevant activities should be improved for better subject interest protection,including clinical trial design,appropriate subjects selection and fully informed consent,research document safety information description,clinical trial risk assessment and safety supervision during the implementation,reimbursement to subjects of damages and complete safety information overview.
Keywords：clinical trialsafety evaluationsubjects
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2646-2651 )