Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to provide guidance for the application of statistical principles in clinical trials in accordance with ICH E9 and E9(R1). It defines processes for developing statistical analysis plans, handling deviations, applying the estimand framework, and ensuring robust data interpretation that supports regulatory submissions and scientific validity.
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The purpose of this SOP is to establish processes for selective safety data collection in clinical trials, in alignment with ICH E19. This approach ensures optimization of safety data collection where comprehensive data are not required, while maintaining subject protection, regulatory compliance, and integrity of safety evaluation.
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The purpose of this SOP is to define processes for managing QT/QTc signals in clinical trials in alignment with ICH E14. QT prolongation poses significant cardiac risks, and proper signal detection and management are essential for ensuring subject safety and meeting regulatory obligations.
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The purpose of this SOP is to define the process for submitting Clinical Trial Authorisations (CTAs) and related notifications to the Medicines and Healthcare products Regulatory Agency (MHRA) via UK national systems, in accordance with post-Brexit regulatory requirements. This ensures that trials conducted in the UK comply with local legislation, independent of EU systems.
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The purpose of this SOP is to describe the process for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to the Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with UK country-specific requirements. This ensures patient safety, compliance with Good Clinical Practice (GCP), and adherence to expedited reporting timelines.
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The purpose of this SOP is to establish standardized procedures to ensure clinical trials in the United Kingdom comply with the UK General Data Protection Regulation (UK-GDPR) and the Data Protection Act (DPA) 2018. It ensures lawful processing of personal data, protection of subject privacy, and secure handling of trial-related records.
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The purpose of this SOP is to establish procedures for submitting, tracking, and managing clinical trial applications and communications with the Health Research Authority (HRA) and Research Ethics Committees (RECs) in the United Kingdom. It ensures that site approvals are obtained and maintained in accordance with UK-specific regulations and Good Clinical Practice (GCP).
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The purpose of this SOP is to define the requirements and detailed procedures for archiving and retention of clinical trial records in the United Kingdom. It ensures compliance with the Medicines and Healthcare products Regulatory Agency (MHRA), UK-GCP, and Data Protection Act (DPA 2018), with emphasis on maintaining data integrity, subject confidentiality, and readiness for regulatory inspection. This SOP also aligns with ICH E6(R2) and reflects UK-specific post-Brexit obligations for record retention.
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The purpose of this SOP is to establish procedures for preparing, submitting, and managing Clinical Trial Applications (CTAs) and related lifecycle events in Canada under Division 5 of the Food and Drug Regulations. It provides guidance for sponsors, CROs, and investigators to ensure compliance with Health Canada requirements, safeguard subject safety, and maintain regulatory transparency. This SOP addresses initial CTA submission, amendments, notifications, withdrawal, and end-of-trial reporting.
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