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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.
Validating documents for countries that do not participate in the Hague Convention can be difficult and time-consuming.
It may take several steps depending on the target country. citizens, and foreign nationals on all documents that will be used in foreign countries.
To open a bank account or engage in other business transactions in these countries, U. companies must provide an apostilled copy of your articles of incorporation or formation.
In an effort to assure interoperability of e TMF data among clinical trial stakeholders, in September 2013 non-profit Care Lex and Sure Clinical Inc initiated an e TMF standards initiative under the OASIS open standards development organization for the development of a global e TMF standard.
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In order to comply with government regulatory requirements surrounding Bio Pharma clinical trials, every organization involved in regulated clinical trials must maintain and store certain 'essential documents' related to the clinical trial to ensure regulatory compliance.