Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to establish procedures for the security, environmental controls, and access management of archives storing clinical trial documents and data. Proper archival practices ensure long-term preservation, inspection readiness, confidentiality, and compliance with ICH GCP, FDA, EMA, CDSCO, WHO, GDPR, and HIPAA regulations.
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The purpose of this SOP is to establish controls that prevent the premature destruction of clinical trial records, ensuring that all documents are retained in accordance with global regulatory requirements. This protects subject rights, preserves data integrity, and maintains inspection readiness.
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The purpose of this SOP is to define standardized procedures for reconciling paper and electronic records in clinical trials, ensuring consistency, accuracy, and compliance. Hybrid records (paper + electronic) must be harmonized to maintain data integrity, subject safety, and regulatory inspection readiness.
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The purpose of this SOP is to define processes for maintaining confidentiality and implementing data protection controls in clinical trials. These measures ensure compliance with global data protection regulations, safeguard subject privacy, and protect trial data from unauthorized access, loss, or breaches.
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The purpose of this SOP is to define the framework for establishing and maintaining a Quality Management System (QMS) in clinical research. The QMS ensures that clinical trial activities are conducted in compliance with ICH GCP, FDA, EMA, CDSCO, WHO, and other regulatory guidelines while promoting a culture of quality, accountability, and continuous improvement.
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The purpose of this SOP is to establish the requirements for training of clinical research staff, including initial and ongoing training, to ensure compliance with Good Clinical Practice (GCP), applicable regulations, and study-specific requirements. Training ensures that staff are competent, compliant, and inspection-ready.
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The purpose of this SOP is to outline the process for evaluating training effectiveness and performing competency sign-off for clinical trial staff. This ensures that individuals are qualified, competent, and authorized to perform assigned trial-related tasks, thereby maintaining compliance with ICH GCP, FDA, EMA, CDSCO, and WHO requirements.
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The purpose of this SOP is to establish procedures for identifying, escalating, and addressing non-compliance in clinical trials through Corrective and Preventive Actions (CAPA). It ensures that deviations and violations are promptly managed to protect subject safety, maintain data integrity, and comply with global regulatory requirements.
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The purpose of this SOP is to define the process for effective Change Control Management in clinical research. Changes in systems, processes, vendors, and trial protocols must be controlled, documented, and approved to ensure compliance with ICH GCP, FDA, EMA, CDSCO, and WHO requirements. This SOP ensures changes are managed in a structured, risk-based, and traceable manner.
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The purpose of this SOP is to outline the procedures for clinical study closeout at both the site and sponsor levels. It ensures all regulatory, ethical, and operational requirements are met prior to study termination, including proper IP reconciliation, TMF/ISF finalization, subject follow-up, regulatory notifications, and archiving of study materials.
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