Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to outline procedures for investigational product (IP) management and accountability in clinical trials conducted in New Zealand. It ensures compliance with Medsafe, Health and Disability Ethics Committees (HDEC), and ICH GCP requirements for receipt, labeling, storage, dispensing, reconciliation, and destruction of IP.
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The purpose of this SOP is to define standardized processes for managing and safeguarding clinical trial data in New Zealand. It ensures integrity, accuracy, and confidentiality of data in compliance with Medsafe, HDEC, and ICH GCP requirements.
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The purpose of this SOP is to describe the standardized process for follow-up and closure of monitoring findings identified during clinical trial monitoring visits. This ensures that deviations, deficiencies, and non-compliance are corrected, preventive actions are taken, and all activities are fully documented for inspection readiness.
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The purpose of this SOP is to establish standardized procedures for oversight and governance of vendors and Contract Research Organizations (CROs) engaged in clinical trials. It ensures that all external partners are qualified, contracted, and monitored effectively, and that sponsor accountability under ICH GCP is maintained. The SOP provides guidance on vendor selection, audits, risk assessments, performance monitoring, CAPA management, and documentation for inspection readiness.
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The purpose of this SOP is to define the process for planning and executing sponsor audits in clinical trials. Sponsor audits ensure compliance with GCP, protocol requirements, and regulatory standards while verifying that clinical trial processes, vendors, CROs, and investigator sites operate in alignment with contractual and ethical obligations.
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The purpose of this SOP is to define procedures for handling audit reports and integrating Corrective and Preventive Actions (CAPA) in clinical trials. Proper documentation and CAPA management ensure that audit findings are addressed in a timely and effective manner, safeguarding subject safety, data integrity, and regulatory compliance.
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To establish standardized, regulatory-compliant processes that ensure continuous inspection readiness at investigator sites and at sponsor/CRO level. This SOP defines proactive measures for maintaining the Trial Master File (TMF) and Investigator Site File (ISF), preparing personnel, coordinating vendor support, staging records for rapid retrieval, and executing structured responses before, during, and after regulatory inspections by agencies such as CDSCO, US FDA, EMA, MHRA, PMDA, and WHO-prequalification programs.
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The purpose of this SOP is to define standardized processes for managing regulatory inspections conducted by agencies such as US FDA, EMA, CDSCO, MHRA, PMDA, and WHO. It ensures that sponsor, CRO, and site staff are prepared, that inspections are handled professionally, and that responses and CAPA to inspection findings are managed within mandated timelines.
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The purpose of this SOP is to describe the standardized setup, structure, and maintenance of the Trial Master File (TMF), whether maintained in paper format or electronic format (eTMF). TMF serves as the central repository of essential documents demonstrating compliance with Good Clinical Practice (GCP) and enabling evaluation by regulatory authorities.
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The purpose of this SOP is to establish a standardized process for contemporaneous filing of essential documents into the Trial Master File (TMF) during the conduct of a clinical trial. This ensures that all trial-related records are accurate, complete, current, and readily available for inspection by regulatory authorities.
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