Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to establish standardized procedures for dispensing and administering investigational products (IP) to trial participants. It ensures that IP is dispensed accurately, administered safely, and recorded appropriately in compliance with Good Clinical Practice (GCP) and regulatory standards.
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This SOP outlines the standardized processes for obtaining Human Research Ethics Committee (HREC) approvals and conducting Site-Specific Assessments (SSA) before trial initiation. It ensures compliance with TGA regulations, GCP principles, and institutional governance requirements for ethical trial conduct in Australia.
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The purpose of this SOP is to define the requirements for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs) to the Therapeutic Goods Administration (TGA). It ensures compliance with GCP, CTN/CTX obligations, and Australian privacy regulations while protecting subject safety and maintaining sponsor responsibilities for pharmacovigilance.
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The purpose of this SOP is to establish procedures for the return and destruction of investigational products (IP) used in clinical trials. This ensures unused, expired, or damaged IP is managed responsibly, maintaining compliance with ethical, regulatory, and environmental standards.
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The purpose of this SOP is to define procedures for reconciliation and accountability of investigational products (IP) throughout the lifecycle of a clinical trial. Accurate reconciliation ensures that all IP is tracked from receipt to dispensing, return, or destruction, thus protecting participant safety and ensuring compliance with regulatory guidelines.
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The purpose of this SOP is to establish requirements for insurance and indemnity in clinical trials conducted under the CTN/CTX schemes in Australia. It ensures sponsor, site, and investigator compliance with TGA, Human Research Ethics Committee (HREC), and institutional governance requirements to safeguard participant rights and provide indemnity coverage for clinical trial-related injuries.
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This SOP describes the procedures for aligning sponsor and investigator activities with the China GCP (2020) requirements and securing necessary approvals from the National Medical Products Administration (NMPA). It ensures compliance with regulatory and ethical obligations for clinical trials conducted in China.
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The purpose of this SOP is to describe standardized procedures for randomization, blinding, and unblinding in clinical trials. These processes ensure unbiased allocation of investigational products, maintain trial integrity, and safeguard subject safety.
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This SOP establishes the procedures for securing approvals for the collection, use, storage, and export of Human Genetic Resources (HGR) in clinical trials conducted in China. It defines sponsor, investigator, and institutional responsibilities to ensure compliance with Chinese HGR regulations under the National Medical Products Administration (NMPA) and the Ministry of Science and Technology (MOST).
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The purpose of this SOP is to establish detailed procedures for handling controlled substances in clinical trials. Controlled drugs, including narcotics and psychotropic substances, require stringent oversight to ensure subject safety, prevent diversion, and maintain compliance with national and international regulations.
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