Trusted Resource for Clinical Trials, Protocols & Progress
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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This SOP outlines procedures for preparing, submitting, and managing communications with Swiss Ethics Committees via the Business Administration System for Ethics Committees (BASEC). It ensures compliance with Swissmedic regulations, ICH GCP, and ethical governance requirements in Switzerland.
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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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This SOP defines the process for preparing multilingual documentation and complying with Switzerland’s specific retention rules for clinical trial documentation. It ensures that subject-facing documents and regulatory submissions are linguistically and legally compliant under Swissmedic and BASEC requirements.
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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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This SOP establishes procedures for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to Swissmedic and Ethics Committees (via BASEC). It ensures compliance with ClinO, ICH GCP, and subject safety protection requirements.
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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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The purpose of this SOP is to establish standardized procedures for transcribing data from source documents to Case Report Forms (CRFs). Proper transcription ensures data integrity, subject safety, regulatory compliance, and readiness for monitoring, audit, and inspection.
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The purpose of this SOP is to establish clear processes for preparing multilingual documentation and ensuring compliance with Swiss retention rules for clinical trial records. It ensures ethical, regulatory, and scientific integrity by meeting Swissmedic, BASEC, and ICH GCP requirements.
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The purpose of this SOP is to outline the standardized process for managing and resolving data queries raised during clinical trials. Data query management ensures discrepancies between Case Report Forms (CRFs) and source documents are identified, clarified, and corrected to maintain data accuracy, integrity, and regulatory compliance.
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