Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define the process for verifying and documenting the capability of investigator sites to provide emergency medical care during clinical trials. It ensures participant safety, compliance with DCGI/CDSCO guidelines, and readiness for handling trial-related medical emergencies in accordance with Indian GCP and NDCTR 2019.
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The purpose of this SOP is to outline the procedure for verifying and documenting the accreditation of local laboratories used in Indian clinical trials. This ensures compliance with DCGI/CDSCO and New Drugs and Clinical Trials Rules (NDCTR 2019), while safeguarding data integrity, reliability, and subject safety. Accreditation primarily refers to NABL (National Accreditation Board for Testing and Calibration Laboratories) certification or equivalent.
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The purpose of this SOP is to outline procedures for aligning clinical trial registration with the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). It ensures transparency, ethical compliance, and accessibility of trial data to the global scientific community and public health stakeholders.
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The purpose of this SOP is to establish standardized procedures for the exchange of safety data with global pharmacovigilance (PV) systems, including VigiBase, the WHO global ICSR (Individual Case Safety Reports) database. This ensures international harmonization, timely reporting, and compliance with WHO pharmacovigilance expectations.
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The purpose of this SOP is to define structured community engagement practices for clinical trials conducted in low- and middle-income countries (LMICs). Community engagement ensures ethical trial conduct, cultural sensitivity, trust-building, and alignment with WHO expectations for equitable participation and transparency in clinical research.
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The purpose of this SOP is to define standardized procedures for conducting vaccine clinical trials in alignment with World Health Organization (WHO) Prequalification (PQ) guidance. Compliance with PQ ensures that vaccine data supports global procurement and use by United Nations agencies and Gavi, strengthening public health impact.
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The purpose of this SOP is to establish structured procedures for timely data sharing and transparency in clinical trials conducted during public health emergencies (e.g., pandemics, epidemics). It aligns with WHO guidance to ensure that trial results contribute rapidly to public health decision-making, while maintaining ethical and regulatory compliance.
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The purpose of this SOP is to define the process for incorporating Quality by Design (QbD) principles into clinical trial planning, conduct, and oversight. It ensures compliance with ICH E8(R1), focusing on study quality by integrating risk-based approaches and identifying critical-to-quality (CtQ) factors that safeguard participant safety and data reliability.
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The purpose of this SOP is to establish standardized procedures for the design, conduct, and oversight of Multi-Regional Clinical Trials (MRCTs) in accordance with ICH E17 guidelines. MRCTs are critical for generating data acceptable across multiple regions, facilitating simultaneous regulatory submissions, and ensuring diversity and representativeness in study populations.
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The purpose of this SOP is to establish a standardized framework for managing safety data in clinical trials in alignment with ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E2B(R3) (Electronic Transmission of Individual Case Safety Reports), and E2F (Development Safety Update Report – DSUR) requirements. This ensures accurate and timely adverse event reporting to regulatory authorities, ethics committees, and global PV databases.
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