00:00When the human trials started, do they have safety or backup?
00:05So, when you start a human trial,
00:08when you get involved in that particular person,
00:11they have insurance.
00:14This is the basic thing as a clinical research company.
00:17Must and should.
00:17Must and should.
00:18They have consent.
00:20They have to say that this is a trial.
00:23This is a trial that will be done in the first place.
00:26This will have side effects, this will be done in the next place.
00:29The consent, the written consent,
00:32the ethics committee, the board.
00:35There is a doctor, a lawyer, a social activist, a layman.
00:41There is a ethics committee board.
00:44The board is approved by the drug controller general of India, DCJ.
00:48The board is approved by the study of the approved process.
00:53That is the insurance.
00:54It is approved by the insurance documents.
00:57The informed consent form has multiple languages.
01:01No one can sign a language.
01:03The other languages can translate.
01:06There are strict regulations.
01:11There are strict regulations.
01:13We should see there.
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