Trusted Resource for Clinical Trials, Protocols & Progress
This SOP defines the processes for preparing, translating, verifying, and controlling bilingual (English and French) documentation used in clinical trials. It ensures compliance with Health Canada Division 5, ICH-GCP, and REB requirements, guaranteeing that participants receive understandable and accurate information while sponsors maintain regulatory compliance and inspection readiness.
Click to read the full article.
This SOP describes the process for preparing, submitting, and managing Clinical Trial Notifications (CTNs), amendments, safety reports, and trial notifications to the Pharmaceuticals and Medical Devices Agency (PMDA). It ensures alignment with Japanese Good Clinical Practice (J-GCP), the PMD Act, and ICH-GCP guidelines to protect participant safety, maintain regulatory compliance, and ensure inspection readiness.
Click to read the full article.
The purpose of this SOP is to outline the procedures for subject retention and follow-up in clinical trials. Retention ensures participants complete the study as planned, enabling reliable data analysis and protecting participant safety while complying with ethical and regulatory standards.
Click to read the full article.
This SOP defines the process for preparing, translating, reviewing, and controlling Japanese language informed consent forms (ICFs) and essential clinical trial documentation. It ensures participant comprehension, regulatory compliance with PMDA and J-GCP, and alignment with ICH guidelines on subject information and documentation governance.
Click to read the full article.
The purpose of this SOP is to define standardized procedures for subject compensation and reimbursement handling in clinical trials. It ensures ethical, transparent, and compliant financial practices that safeguard participant welfare and maintain trust in the research process.
Click to read the full article.
This SOP describes the requirements and processes for safety reporting to the Pharmaceuticals and Medical Devices Agency (PMDA). It defines obligations for sponsors, investigators, and pharmacovigilance teams for expedited reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and other reportable events in compliance with Japanese Good Clinical Practice (J-GCP) and international pharmacovigilance standards.
Click to read the full article.
The purpose of this SOP is to outline standardized procedures for the receipt and verification of investigational products (IP) at clinical trial sites. This ensures that the product is received in good condition, verified against shipping documents, and appropriately recorded for accountability and regulatory compliance.
Click to read the full article.
This SOP defines the standardized process for site data submission formatting and translation quality assurance (QA) for clinical trials conducted under the oversight of the Pharmaceuticals and Medical Devices Agency (PMDA). It ensures that site-level documents and datasets submitted in Japanese or translated from English are accurate, compliant with J-GCP, and ready for regulatory inspection.
Click to read the full article.
The purpose of this SOP is to establish standardized procedures for the storage, temperature monitoring, and excursion management of investigational products (IP) at clinical trial sites. Proper storage safeguards product integrity, ensures participant safety, and maintains compliance with regulatory requirements.
Click to read the full article.
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.
