Trusted Resource for Clinical Trials, Protocols & Progress
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
