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A Guide to Regulatory Affairs in the Pharmaceutical Industry
Regulatory Affairs (RA) serves as the critical interface between pharmaceutical companies and the global health authorities responsible for safeguarding public health. This function is not merely administrative; it is a strategic discipline that guides a therapeutic product through the complex regulatory framework, from initial nonclinical research through to post-market surveillance. The Strategic Role of Regulatory
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Audit trails in clinical trial documentation: purpose, structure, and oversight
In the context of clinical trials, an audit trail is a secure, computer-generated, and time-stamped electronic record that allows for the reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. This chronological log is essential for demonstrating data integrity, fulfilling regulatory requirements, and ensuring that all actions
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Document Traceability Across the Clinical Trial Lifecycle: An Audit-Ready Guide
Document traceability is the complete, verifiable history of a clinical trial document. It encompasses the entire lifecycle, from the initial draft to the final archived version, capturing every change, review, and approval. This creates an auditable record that demonstrates the integrity of study documentation. The Foundation of Document Traceability In a clinical trial, documents are
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Common Documentation Findings During Regulatory Inspections
Regulatory inspections are a critical checkpoint in the clinical development lifecycle, serving to verify the integrity of trial data and ensure the protection of participant rights and safety. For professionals in pharmaceutical, biotech, and contract research organizations (CROs), maintaining impeccable documentation is not merely an administrative task. It is the foundation of a successful regulatory
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Navigating the EU Clinical Trials Regulation (CTR) and its Impact on Documentation Workflows
The European Union's Clinical Trials Regulation (CTR) represents a fundamental shift in the operational management of clinical trial documentation. The transition from separate, national submissions under the former Clinical Trials Directive (CTD) to a single, centralized system—the Clinical Trials Information System (CTIS)—necessitates significant adjustments to documentation workflows. The regulation's core tenets of harmonization and transparency
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Understanding FDA 21 CFR Part 11 Implications for Clinical Documentation
The FDA 21 CFR Part 11 regulation defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. For clinical documentation, this requires implementing specific procedural and technical controls to ensure the authenticity, integrity, and, where appropriate, the confidentiality of electronic records. These controls affect how clinical