Trusted Resource for Clinical Trials, Protocols & Progress
This SOP establishes standardized procedures for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with MFDS safety reporting timelines, Korean GCP (KGCP), and international guidelines, thereby protecting patient safety and ensuring inspection readiness.
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The purpose of this SOP is to define the requirements for audit trails and change control in electronic systems (eSystems) used for clinical trial data management. Audit trails ensure transparency and accountability, while change control guarantees that system modifications are authorized, documented, and validated.
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The purpose of this SOP is to define the process for preparing, submitting, and managing Health and Disability Ethics Committee (HDEC) submissions in New Zealand. It ensures compliance with New Zealand ethical standards, GCP requirements, and specific HDEC conditions of approval.
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The purpose of this SOP is to define standardized procedures for the use of electronic signatures and identity management in clinical trials. It ensures that signatures applied to trial documents are attributable, authentic, secure, and compliant with international regulatory requirements including FDA 21 CFR Part 11, ICH GCP (E6 R2), EMA computerized system guidelines, CDSCO, and WHO expectations. Proper identity management prevents unauthorized access, ensures accountability, and supports data integrity principles such as ALCOA+.
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The purpose of this SOP is to define procedures for engaging in Māori consultation and ensuring cultural safety in trial design and informed consent processes in New Zealand. It ensures respect for indigenous rights, cultural protocols, and compliance with Health and Disability Ethics Committees (HDEC) and GCP requirements.
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The purpose of this SOP is to establish systematic processes for performing data backup and disaster recovery (DR) in clinical trials. It ensures the protection of critical study data, prevents data loss, guarantees business continuity, and safeguards compliance with regulatory requirements such as FDA 21 CFR Part 11, ICH GCP, EMA, CDSCO, and WHO guidance. This SOP aims to maintain integrity, availability, and accessibility of data throughout the trial lifecycle.
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The purpose of this SOP is to define procedures for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in New Zealand, in compliance with Medsafe and Health and Disability Ethics Committees (HDEC) requirements. It also covers privacy obligations under the Privacy Act 2020 to protect participant data.
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The purpose of this SOP is to define systematic procedures for data migration and archiving of eClinical systems used in clinical trials. It ensures that data is transferred, stored, and retained securely without loss of integrity, guaranteeing compliance with global regulatory standards including ICH GCP, FDA 21 CFR Part 11, EMA, CDSCO, and WHO requirements. This SOP also aims to establish long-term accessibility, auditability, and regulatory inspection readiness.
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The purpose of this SOP is to outline requirements for insurance, indemnity, and Accident Compensation Corporation (ACC) considerations in clinical trials conducted in New Zealand. It ensures protection of trial participants, compliance with HDEC and Medsafe expectations, and adherence to GCP standards.
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The purpose of this SOP is to establish processes for ensuring clinical trial data systems comply with Privacy, GDPR (General Data Protection Regulation), and HIPAA (Health Insurance Portability and Accountability Act) requirements. This SOP protects the rights of trial participants, ensures lawful data processing, and maintains global regulatory compliance while safeguarding personal health information (PHI) and personally identifiable information (PII).
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