Guest guest Posted July 27, 2010 Report Share Posted July 27, 2010 Hi, Human rights teach that no human should be addressed as " subject " because it is insulting and subjugates the individuals. Hence the use of word " participant " is advocated to show due respect to those who volunteer and come forward to take part in research. Dr Vijay Thawani > > Assessment of Efficacy: > Efficacy Parameters >          Include the specifications of the efficacy parameters. > Method and Timing >         Include methods and timing for assessing, recording and analyzing efficacy parameters. >  >  > Subject compliance >  Recording of patient compliance information (what will be recorded, when and where). >  Detail of follow-up of non compliant subjects. >  > Withdrawal of Subjects >  Subject withdrawal criteria and procedures identifying: > o When and how to withdraw subjects. > o The type and timing of any data to be collected for withdrawn subjects. > o Whether subject would be replaced and if so the methods for doing this. > o The follow up procedures for withdrawn subjects. >  > dr.Smita > Quote Link to comment Share on other sites More sharing options...
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