The pregnancy in subjects, purchase of insurance, protocol deviation, and integrity of clinical research associate during clinical research
Huang Di
Li Bin
Weng Hong
Zeng Xiantao
Abstract：During the execution of a clinical research, may occur unexpected events or issues beyond the consideration of protocol. Therefore, in order to assure the quality of study and validity of results, every possibility should be accounted for and preventive procedures planned at the beginning of study design. Potential issues in study execution, such as pregnancy in subjects, purchase of insurance, protocol deviation and integrity of clinical research associate were discussed in this paper, as well as ways to analyze and respond to them.
Keywords：Clinical researchClinical trialPregnancy in subjectsPurchase of insuranceProtocol deviation
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 897-899 )