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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

Table 5. In performing clinical studies, the duties of sponsor‑initiated clinical trials (SITs) and investigator‑initiated trials (IITs)
Responsibilities IITs SITs
Responsibility holder Principal investigators conduct their own clinical studies Pharma Industries
IB, protocol, and SOP before clinical studies Principal investigators conduct their own clinical studies Pharma Industries
Production or importation of IP IP Supplier (Pharma Industries ) Pharma Industries
Clinical study center Hospital Hospital
When conducting clinical studies reaction to the regulatory agency Principal investigators conduct their own clinical studies Pharma Industries
throughout as well as after studies (notice of clinical trials submitted,
safety reports)
Monitoring/audit Principal investigators conduct their own clinical studies (or Pharma Industries
the individual to whom they allocate)
Records (data management, statistical analysis, CSR) Principal investigators conduct their own clinical studies Pharma Industries
NDA Pharma Industries Pharma Industries
Abbreviations: CSR: Corporate social responsibility; IB: Investigator’s brochure; IP: Investigational product; NDA: New drug application; SOP: Standard
operating procedure; SIT: Sponsor-initiated clinical trial; IIT: Investigator-initiated trial.

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Acknowledgments doi: 10.3390/pharmaceutics15102431
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Chandrashekhar Upasani
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