Blinding and Unblinding in Clinical trials||Clinical Research||Trial master file

Blinding is a procedure in which human participant and investigator kept unaware about treatment or medication that are going to perform on human participant.
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[@koushalkaril619]

Thank u , very helpful

[@VikasSinghPharmalive]

You're welcome Koushal😊

[@mayuripatil3392]

hello sir, in double blinding study both subject and investigator are unaware of IP then how investigator work in this if he didnt know anything about IP

[@VikasSinghPharmalive]

Thanks for your question Mayuri. In Clinical trial there is 1 Document called as investigator brochure in which detail description of Investigational product is given and before enrolling any human subject each investigator need to ensure that they understood investigator brochure so investigator already know IP properties. While coming to your question in double Blinding investigator only kept unaware about the fact that which human subject recieving placebo and which Human subject recieving IP so by this way any chances of investigator biasness get overruled. In case of life threating side effect there is an option available of Unblinding