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Showing posts from January, 2009

Good Clinical Practices

Answered by Dr Arun Bhatt in Pharmabiz.com

Q. What is the definition of a legally acceptable representative (LAR)?

As per Schedule Y, an LAR is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). This would usually include parents, adult children, adult siblings, and spouse.

Q. Can a daughter-in-law sign as LAR for her mother-in-law in informed consent process?

If mother-in-law is literate, you do not need an LAR. If mother-in-law illiterate, she can put her left hand thumb impression on the consent form. In this situation, you do not need an LAR but an impartial witness. In such a situation, the daughter-in-law will sign as an impartial witness.

Q. Do we need to take DCGI approval for conducting comparative efficacy trials on already marketed drugs in India? Which one will be the comparator product in such cases among different old drug brands?

You need to consider whether this study falls into one of the new drug catego…