16th DIA Conference on European Electronic Document Management

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Stop Paper Thinking!

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Description

Since the introduction of the computer, documentation processes have moved from paper-generating tasks to paper-facilitating tasks. All outcomes are still able to print on paper, similarly as it is shown on the screen. It reduced the amount of paper, but it did not allow us to view data in multiple perspectives. This would require a reporting functionality based on smart queries. Current electronic regulatory dossiers are limited to a compilation of PDF documents built up in pages of A4 or letter format. Similarly, the majority of electronic Trial Master File (TMF) information is built up in pages of A4 or letter format and XEVMPD/IDMP data is managed independently and duplicative of source document. The US FDA as well as Health Canada require datasets on the clinical data and electronic data capture does not necessarily fit in A4 or Letter format. Moreover, FDA CDER asks for BIMO datasets that contain GMP type of information from the TMF and CSR. The MHRA have confirmed that the TMF should not be restricted to documents but should also include data sets, audit trails and system information. Together with the IDMP requirements and the clinical trial data access, it is clear that paper thinking is no longer suited for the increased need for transparent data!

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