Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define processes for ensuring compliance with the Swiss Ordinance on Clinical Trials in Human Research (ClinO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). It outlines the submission, approval, conduct, monitoring, and reporting requirements under Swissmedic, ensuring ethical and regulatory adherence.
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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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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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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 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.
Click to read the full article.
The purpose of this SOP is to define a clear, regulatory-compliant process for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in Switzerland. It ensures compliance with the Ordinance on Clinical Trials (ClinO), ICH GCP, Swissmedic requirements, and ethics committee oversight, thereby safeguarding trial subjects and maintaining trial credibility.
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