Validating country documents
As a result of the FDA's Part 11 policy supporting the use of electronic records and digital signatures in lieu of paper, US organizations involved in U. clinical trials can move from a paper-based TMF to an electronic TMF (e TMF), and still be in compliance with FDA regulatory policies.
The definition of what comprises an e TMF is defined by the regulatory agency with jurisdiction over the clinical trial.
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 initiative, known as the OASIS e TMF Standard Technical Committee, has a stated objective to "define an open, internationally recognized standard that will assure information interoperability among clinical trial stakeholders in the Bio Pharma industry." According to minutes from the OASIS e TMF Standard Technical Committee (TC), the standards initiative is coordinating the efforts of clinical trial sponsors, CRO’s (Contract Research Organizations), academic research organizations, and vendors to develop an ISO standard.
As of July 2014, a list of members in the OASIS e TMF Standard TC includes Care Lex, Forte Research, Fujitsu, HL7, Mayo Clinic, Next Docs, Oracle, Paragon Solutions, Phlexglobal, Safe-Bio Pharma, Sterling Bio, and Sure Clinical.
An apostille is a certification that allows a government office to recognize a document for use in a foreign country without certification from either the US State Department or the country’s embassy or consulate.
Apostilles are authorized under Convention 12 of the Hague, and are only an option for countries that are part of the Hague Convention.
Consular and embassy officials have been known to reject documents and provide little or no explanation.
In order to lower costs and to expedite the clinical trials approval processes, government agencies involved in regulating clinical trials such as the U. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been developing technology initiatives. S., the FDA created regulation CFR 21 Part 11 which supports the use of electronic records, digital media and digital signatures in clinical trials.
In clinical trials and healthcare, enterprises with manual paper-based systems are seeking to transition to automated electronic enterprise content management (ECM) systems to ensure higher levels of regulatory compliance for reduced business risk.
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.