Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to establish standardized procedures for reporting serious adverse events (SAEs) to the sponsor in clinical trials. This ensures subject safety, regulatory compliance, and timely communication for expedited safety reporting obligations.
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The purpose of this SOP is to establish procedures for reporting serious adverse events (SAEs) to Ethics Committees (EC) or Institutional Review Boards (IRB) to protect participant safety and ensure compliance with international regulations and Good Clinical Practice (GCP).
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The purpose of this SOP is to describe the procedures for reporting serious adverse events (SAEs) to regulatory authorities in compliance with global requirements. It ensures timely reporting, accurate documentation, and subject safety.
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The purpose of this SOP is to provide standardized procedures for the reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities and designated portals. It ensures expedited safety communication and regulatory compliance globally.
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The purpose of this SOP is to describe standardized procedures for the medical management of serious adverse events (SAEs) and intercurrent illness in clinical trials. This ensures participants receive appropriate medical care, while maintaining compliance with regulatory requirements and ensuring timely communication with sponsors and regulators.
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The purpose of this SOP is to define procedures for reporting and managing pregnancies occurring in clinical trial participants or partners of participants exposed to investigational products (IP). It ensures maternal and fetal safety, regulatory compliance, and accurate documentation.
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The purpose of this SOP is to establish clear procedures for detecting, evaluating, and managing safety signals during clinical trials. Signal detection is a critical component of pharmacovigilance, enabling early identification of potential safety issues, risk minimization, and regulatory compliance.
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The purpose of this SOP is to provide step-by-step procedures for preparing and submitting Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs). These reports ensure systematic evaluation of cumulative safety data, regulatory compliance, and effective risk-benefit monitoring.
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The purpose of this SOP is to define the standards for creating, maintaining, and verifying source documentation in clinical trials based on ALCOA/ALCOA+ principles. Proper documentation ensures data integrity, subject safety, regulatory compliance, and inspection readiness.
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The purpose of this SOP is to define standardized procedures for the accurate completion, verification, and review of Case Report Forms (CRFs) in clinical trials. Proper CRF management ensures data integrity, compliance with regulatory requirements, and readiness for audits and inspections.
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