Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to describe the management, filing, and verification of essential documents required before the initiation of a clinical trial, in accordance with ICH E6 §8, GCP, and global regulatory authority expectations. These documents collectively demonstrate trial preparation, regulatory compliance, and readiness for initiation.
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The purpose of this SOP is to define the process for collecting, filing, and maintaining essential documents during the conduct of a clinical trial, as per ICH E6 §8 requirements. These documents collectively enable the evaluation of trial conduct and ensure compliance with GCP, regulatory expectations, and subject protection.
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The purpose of this SOP is to define standardized procedures for collecting, filing, and archiving essential documents after the completion of a clinical trial. These records demonstrate that the trial was conducted in compliance with GCP, regulatory requirements, and ethical standards, and that data generated is credible and verifiable.
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The purpose of this SOP is to define processes for managing access, permissions, and security of Trial Master Files (TMF/eTMF), ensuring that only authorized personnel have appropriate access in compliance with ICH GCP, 21 CFR Part 11, EMA Annex 11, CDSCO, and WHO requirements.
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The purpose of this SOP is to establish standardized processes for archiving and retaining Trial Master Files (TMF/eTMF) in compliance with multi-regional requirements. Proper archiving ensures that essential documents are preserved, secure, accessible, and inspection-ready for the retention period defined by regulatory authorities such as FDA, EMA, CDSCO, MHRA, PMDA, and WHO.
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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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