Trusted Resource for Clinical Trials, Protocols & Progress
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 the process for developing a monitoring plan in clinical trials, with emphasis on Risk-Based Monitoring (RBM). The monitoring plan provides a structured approach to ensure subject safety, data integrity, and compliance with regulatory requirements, while optimizing monitoring resources through a risk-based strategy.
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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 define the standardized procedures for conducting onsite monitoring visits and performing Source Data Verification (SDV) in clinical trials. Onsite monitoring ensures participant safety, data integrity, compliance with the protocol, and adherence to ICH GCP, FDA, EMA, CDSCO, and WHO requirements.
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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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The purpose of this SOP is to establish standardized procedures for conducting remote and central monitoring of clinical trials. These approaches complement or replace traditional onsite monitoring in specific scenarios, allowing continuous oversight of trial conduct, subject safety, and data integrity while supporting risk-based monitoring (RBM) frameworks.
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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 procedures for executing and documenting Risk-Based Monitoring (RBM) activities in clinical trials. RBM focuses on prioritizing resources on critical data and processes that affect subject safety and data integrity, ensuring efficiency and compliance with ICH GCP, FDA, EMA, CDSCO, and WHO regulatory requirements.
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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 define standardized procedures for preparing, reviewing, approving, and communicating monitoring visit reports (MVRs) in clinical trials. This ensures timely documentation of monitoring findings, effective communication with investigators and sponsors, and compliance with regulatory expectations, thereby safeguarding subject safety and data integrity.
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