Trusted Resource for Clinical Trials, Protocols & Progress
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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The purpose of this SOP is to define procedures for coding, cleaning, and performing quality checks on clinical trial data. These steps ensure accuracy, consistency, and regulatory compliance, supporting reliable statistical analysis and reporting.
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The purpose of this SOP is to define processes for submitting clinical trial applications and related documentation to the Ministry of Food and Drug Safety (MFDS) in South Korea, while ensuring full alignment with Korean Good Clinical Practice (KGCP). It ensures that sponsor and investigator obligations are fulfilled in compliance with local regulations and international GCP standards.
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The purpose of this SOP is to define the process for locking clinical trial databases and managing unblinding in blinded trials. These procedures ensure the integrity of data, protect trial blinding, and guarantee regulatory compliance prior to statistical analysis and reporting.
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This SOP defines processes for managing electronic source (eSource) and eClinical data in clinical trials conducted in South Korea. It ensures compliance with MFDS regulations, Korean Good Clinical Practice (KGCP), and international GCP standards regarding data integrity, authenticity, confidentiality, and retention.
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The purpose of this SOP is to establish procedures for making corrections to clinical trial documents, managing document versions, and maintaining audit trails. Proper documentation management ensures compliance with data integrity standards, facilitates regulatory inspections, and safeguards trial credibility.
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This SOP defines requirements for preparing informed consent forms (ICFs) and essential documents in the Korean language, ensuring cultural, linguistic, and regulatory compliance. It ensures participant comprehension, ethical compliance, and alignment with MFDS and Korean GCP standards.
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The purpose of this SOP is to establish standardized procedures for validating computerized systems used in clinical trials. Computerized System Validation (CSV) ensures that electronic systems are fit for purpose, operate consistently, and maintain compliance with regulatory requirements for data integrity, security, and reliability.
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The purpose of this SOP is to establish a standardized process for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with Ministry of Food and Drug Safety (MFDS) regulations, Korean Good Clinical Practice (KGCP), and international safety reporting standards, thereby safeguarding trial participants and ensuring data integrity.
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The purpose of this SOP is to establish secure processes for managing access control and user authorization in both paper-based and electronic clinical trial systems. Proper access control ensures data confidentiality, integrity, and accountability, protecting trial data from unauthorized access or alteration.
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