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The purpose of this SOP is to establish standardized procedures for reporting and managing Suspected Unexpected Serious Adverse Reactions (SUSARs) and Individual Case Safety Reports (ICSRs) through the European Medicines Agency’s (EMA) EudraVigilance system. This ensures compliance with EU Clinical Trials Regulation (CTR), Good Pharmacovigilance Practices (GVP), and applicable EMA guidance.
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The purpose of this SOP is to define standardized procedures for handling General Data Protection Regulation (GDPR) data subject rights in clinical trials, specifically access, deletion, and restriction requests. It ensures compliance with EU CTR 536/2014, GDPR Articles 12–23, and EMA guidance while safeguarding subject confidentiality and data integrity.
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The purpose of this SOP is to define standardized procedures for labelling Investigational Medicinal Products (IMPs) and medical devices in compliance with European Union requirements under Annex 13 of Directive 2001/20/EC and Annex VI of the EU Medical Device Regulation (EU MDR 2017/745). This ensures subject safety, trial integrity, and regulatory compliance.
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The purpose of this SOP is to establish a standardized process for managing Paediatric Investigation Plan (PIP) obligations as mandated under the European Paediatric Regulation (EC No 1901/2006). This ensures that sponsors comply with EMA requirements for the development and authorization of medicines intended for use in children, including deferrals and waivers.
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The purpose of this SOP is to define requirements and processes for archiving essential clinical trial records for a minimum of 25 years, in compliance with the EU Clinical Trials Regulation (EU CTR 536/2014) and EMA guidance. This SOP ensures sponsor accountability for secure, long-term storage of both paper and electronic records.
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The purpose of this SOP is to outline the Qualified Person (QP) certification process and define expectations for the interface between Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) during clinical trial product release. This ensures Investigational Medicinal Product (IMP) batches are certified, documented, and released in compliance with EU GMP Annex 13, EMA guidelines, and EU CTR 536/2014 requirements.
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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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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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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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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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