Trusted Resource for Clinical Trials, Protocols & Progress
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 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 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 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 outline the establishment, responsibilities, and operational procedures for the Data Safety Monitoring Board (DSMB) in clinical trials conducted in New Zealand. It ensures compliance with Medsafe, HDEC, and international GCP requirements, protecting trial participants through independent oversight of safety and efficacy data.
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The purpose of this SOP is to define processes for clinical trial registration and updates in the Australia New Zealand Clinical Trials Registry (ANZCTR). This ensures transparency, ethical compliance, and alignment with Medsafe, HDEC, WHO, and International Committee of Medical Journal Editors (ICMJE) requirements for trial registration and result disclosure.
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The purpose of this SOP is to establish standardized procedures for obtaining, documenting, and archiving informed consent in clinical trials in New Zealand. It ensures compliance with Medsafe, Health and Disability Ethics Committees (HDEC), and ICH GCP requirements to protect participants’ autonomy and rights.
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This SOP defines standardized processes for clinical trial monitoring and oversight in New Zealand. It ensures compliance with Medsafe, HDEC, and ICH GCP requirements to safeguard participant rights, ensure data integrity, and verify protocol adherence.
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The purpose of this SOP is to establish processes for safety reporting and pharmacovigilance in clinical trials conducted in New Zealand. It ensures compliance with Medsafe, HDEC, and ICH GCP requirements to protect participant safety and ensure regulatory reporting obligations are met.
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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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