Approach either PI or Clinical Studies Division/Research Coordinator with study proposal. If approaching the Clinical Studies Division, a suitable PI for the study will be suggested. If PI directly is approached, he/she will forward all information to the Clinical Studies Division.
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The PI will then present the case to the Research Subcommittee (RSC) (hyperlink). Should the RSC approve the study, the same shall be tabled in the next Institutional Ethics Committee meeting (IEC meeting is held every 3 months)
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All EC dossiers must be submitted to the IEC (hyperlink) at least 21 days prior to the scheduled meeting date. The EC dossiers must include all essential documents. Special emphasis is given on site-specific Informed Consent Forms for the regional languages i.e. Bengali and Hindi. The translations of the English ICFs must be lucid enough for the lay person to understand, without compromising on the actual content of the document.
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Once the IEC approval for a study is received, the Clinical Trial Agreement (CTA) is finalized.
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After the CTA is in place, proceed for site initiation and recruitment.
