Essential Components of a Study Protocol and Financial Planning in Clinical Research: Indian GCP Overview

Description

DOI: https://doi.org/10.5281/zenodo.18414305

Maithili Janye¹, Ritu Tiwari², Harshita Koli³, Sneha A Bhat⁴, Srishti Gupta⁵, and Kuldeep Kumar⁶ (Clinical Research, Fortis Hospital Mumbai & Fortis Healthcare Research Foundation, Gurugram Haryana¹, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh², and Fortis Healthcare Research Foundation, Gurugram Haryana^3,4,5,6)

This document presents a comprehensive outline of the requirements for submitting a clinical research application to the Ethics Committee (EC) in compliance with the Indian Good Clinical Practice (GCP) Guidelines. It details the key components of a study protocol which includes research objectives, rationale, methodology, investigator qualifications, recruitment plans, eligibility criteria, and informed consent procedures. The guidelines underscore participant safety, data confidentiality, and ethical conduct throughout the study. They also address risk management, Financial Aspects, compensation, data handling, and the publication of all results to promote transparency and accountability. Financial arrangements and insurance coverage are emphasized to ensure proper budgeting, disclosure of funding sources, and protection against study-related injuries. Additionally, the document highlights the importance of obtaining regulatory approvals, declaring conflicts of interest, and adhering to both national and international GCP standards. Overall, it provides a practical framework for conducting ethical, scientifically sound, and globally compliant clinical research in India.