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Research On Legal Issues Of Drug Clinical Trials In China

Posted on:2018-12-01Degree:MasterType:Thesis
Country:ChinaCandidate:J WangFull Text:PDF
GTID:2356330536988743Subject:legal
Abstract/Summary:PDF Full Text Request
The world of medical is having made a spurt of progress in the past thirty years,and drug clinical trials played an important role in the process.Drug clinical trials is a vital way to defeat different kinds of stubborn diseases and lead us to the healthy life.Besides,human beings benefit a lot from the successful drug clinical trials.However,every coin has two sides.When drug clinical trials take healthy life to human beings,it always sacrifices the rights and interests of the subjects.So,the subjects haven't got the effective protection.Many cases of hurting rights and interests of the subjects happened in the history,and now more and more people are paying attention to the protection of the subjects.Recently,the medical level in our country is as improving as the economical development level,and the number of drug clinical trials is growing.How to normalize the behavior of drug clinical trials and protect the rights and interests of the subjects will be tough law problems.From this assay,we will find the law problems in the drug clinical trials through ravel out the rights and obligations of all the participators and then I will put forward some solutions through finding some information.I hope I will make a contribution to the drug clinical trials in our country.The full text is divided into four chapters and includes introduction and conclusion.The first chapter introduces the historical development of drug clinical trials and the legislative status at home and abroad.The Second Word War(WW ?)is the principal line of the historical development.The historical development of drug clinical trials includes the early drug clinical trials,the WW ? period drug clinicaltrials and the postwar drug clinical trials.The legislative status at home and abroad includes foreign legislation and national legislation.The second chapter introduces all the participator of the drug clinical trials,like subject,researcher,sponsor,IRB and their rights and duties.The third chapter introduces some legal problems of the participators.The last chapter introduces plenty of solutions to deal with the problems that last chapter puts forward.
Keywords/Search Tags:drug clinical trials, participator, subject protection, legal measure
PDF Full Text Request
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