Trusted Resource for Clinical Trials, Protocols & Progress
This SOP establishes the processes for Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) submissions, management, and notifications to the Therapeutic Goods Administration (TGA). It ensures sponsor and investigator responsibilities are defined, submissions are accurate and timely, and clinical trials remain compliant with GCP and Australian regulatory requirements.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
