Clinical Trials: CDSCO/DCGI – Unique SOPs (India)

SOP for DCGI NOC/CTA and Protocol Amendment Submissions

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The purpose of this SOP is to define procedures for submitting Clinical Trial Applications (CTAs), obtaining No Objection Certificates (NOCs), and managing protocol amendments with the Drugs Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO). It ensures compliance with Indian GCP (2019), New Drugs and Clinical Trials Rules, 2019, and aligns with global regulatory expectations.

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CDSCO/DCGI - Unique SOPs (India), SOP for GCP

SOP for AV Recording of Consent (NCEs; Defined Therapy Areas) and Retention

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The purpose of this SOP is to establish standardized procedures for mandatory audio-visual (AV) recording of the informed consent process in clinical trials involving New Chemical Entities (NCEs) and specific therapy areas as required by the Drugs Controller General of India (DCGI) under the New Drugs and Clinical Trials Rules (NDCTR), 2019. It ensures subject rights, transparency, and regulatory compliance.

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CDSCO/DCGI - Unique SOPs (India), SOP for GCP

SOP for SAE Compensation Assessment, Payment, and Reporting Timelines

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The purpose of this SOP is to define procedures for the assessment, payment, and reporting of Serious Adverse Event (SAE) compensation in clinical trials conducted in India. It ensures compliance with the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), and New Drugs and Clinical Trials Rules (NDCTR), 2019. The SOP safeguards participant rights and ensures transparency in compensation timelines.

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CDSCO/DCGI - Unique SOPs (India), SOP for GCP

SOP for EC Registration Verification and Communications (Country-Specific)

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The purpose of this SOP is to establish procedures for verifying Ethics Committee (EC) registrations and managing communications with ECs in compliance with the Drugs Controller General of India (DCGI), CDSCO, and the New Drugs and Clinical Trials Rules (NDCTR) 2019. This ensures that all ECs involved in clinical trials are properly registered and that communications meet country-specific regulatory requirements.

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CDSCO/DCGI - Unique SOPs (India), SOP for GCP

SOP for Site Capability for Emergency Care Verification and Documentation

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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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CDSCO/DCGI - Unique SOPs (India), SOP for GCP

SOP for Local Lab Accreditation Verification and Documentation (India-Specific)

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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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CDSCO/DCGI - Unique SOPs (India), SOP for GCP