Validating country documents

An e TMF system consists of software and hardware that facilitates the management of regulated clinical trial content.

Regulatory agencies have outlined the required components of e TMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.

The term e TMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content.However, if a clinical trial elects to store trial master file 'essential documents' in electronic format, then the e TMF system used to store those files is subject to regulatory controls specified under FDA Title 21 CFR Part 11.With respect to the FDA, the required components, controls and policies for an e TMF used in US based clinical trials follow US FDA CFR 21 Part 11 requirements.Signatures and seals of US government agencies must be certified by the foreign embassy or consulate of the target country – a process called legalization.An electronic trial master file (e TMF) is a trial master file in electronic (digital content) format.

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As a result of the lack of a standard to represent e TMF content, e TMF information interoperability and content exchange between systems and applications is inefficient.

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