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…
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…
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…
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…
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…
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…
When a sponsor delegates elements of a clinical trial to a CRO, a critical operational question arises: "Who is responsible for the Trial Master File?" An eTMF governance model for sponsors and CROs provides the formal answer. It is the…
Effective TMF quality control and ongoing oversight is a foundational component of an inspection-ready clinical trial. The objective is not merely to collect documents but to establish and maintain a system that demonstrates the integrity of a trial’s conduct from…
Maintaining the Trial Master File (TMF) in a state of completeness and inspection readiness is a continuous operational discipline throughout the clinical trial lifecycle. The objective is to manage the TMF actively so that it is complete, timely, and of…
Effective clinical study report authoring and version management is a highly structured, auditable process integral to regulatory submissions. The process involves creating, reviewing, and finalizing the definitive account of a clinical trial, demanding a systematic focus on data integrity, transparency,…