Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to establish a compliant process for destruction and disposition of Trial Master Files (TMF/eTMF) after the retention period defined by applicable regulations. It ensures that documents are destroyed securely, documented properly, and traceability is maintained, while respecting confidentiality and data protection laws.
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The purpose of this SOP is to establish standardized, regulatory-compliant procedures for the collection, labeling, processing, storage, and documentation of biological samples in clinical trials. Proper handling of biospecimens ensures subject safety, sample integrity, and reliability of laboratory test results.
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The purpose of this SOP is to define a standardized procedure for labeling, anonymizing, and pseudonymizing biological samples collected during clinical trials. This ensures confidentiality of subject identity, integrity of sample tracking, and compliance with ICH GCP and data privacy regulations such as GDPR, HIPAA, and regional laws.
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The purpose of this SOP is to establish standardized procedures for the shipment of biological samples in clinical trials, ensuring integrity, confidentiality, and compliance with international guidelines such as ICH GCP, FDA, EMA, CDSCO, WHO, and IATA Dangerous Goods Regulations.
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The purpose of this SOP is to establish standardized, regulatory-compliant procedures for cold chain management of biological samples and investigational products (IP) during clinical trials. This ensures product stability, subject safety, and data integrity by maintaining required storage and transport temperatures.
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The purpose of this SOP is to define procedures for the retention and destruction of biological samples collected during clinical trials. Proper retention ensures availability of samples for regulatory inspection, additional testing, and verification, while destruction safeguards confidentiality and subject rights once retention timelines expire.
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The purpose of this SOP is to outline standardized, regulatory-compliant procedures for performing bioanalytical testing and reporting results from clinical trial samples. This ensures reliability of pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data while maintaining data integrity for regulatory submissions.
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The purpose of this SOP is to define processes for calibration and maintenance of laboratory equipment used in clinical trial sample analysis, ensuring that results are accurate, reliable, and reproducible. Proper equipment management is critical for compliance with ICH GCP, GLP, FDA, EMA, CDSCO, and WHO requirements.
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The purpose of this SOP is to ensure that laboratories performing clinical trial analyses are accredited, qualified, and compliant with global regulatory and quality standards. Verification of accreditation and qualification safeguards data integrity and subject safety while ensuring inspection readiness.
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The purpose of this SOP is to establish standardized procedures for record retention in clinical trials, defining global durations and triggers that align with ICH GCP, FDA, EMA, CDSCO, WHO, GDPR, and HIPAA requirements. Proper record retention ensures availability of essential documents for audits, inspections, pharmacovigilance, and legal defense.
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