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- 05/07/2007 12:00:00 - Infonetica Announce the Launch of Tissue Auditor Tissue Auditor is designed to meet the new regulatory requirements of handling human tissue samples. Tissue Auditor meets and exceeds these requirements while being able to be integrated into Infonetica's existing product offerings. learn more |
COREC has successfully developed an Information Technology (IT) platform to support the application and process for ethical approval in the UK. This work was
subject to a previous tender and developed by Infonetica Ltd. COREC is seeking to use this existing IT platform to provide similar systems for the wider regulatory process including NHS Research and Development (R&D), Gene Therapy Advisory Committee (GTAC) and Patient Information Advisory Group (PIAG).
COREC first issued the National Application Form, for use initially for application to Multi-centre Research Ethics Committees (MRECs) in February 2003. The Form was originally developed using a software package, Office Forms, that required users to download the software from the COREC website. This raised practical problems for users with local IT restrictions on software and also the software was not compatible with Apple Macs.
A key strategic decision was therefore made to develop a web-based version of the Form which did not require users to download any software and simply required internet access. Use of the National Form was made mandatory a year later once the online form system was developed and for a further year both the ''offline'' and ''online'' Form systems were supported. The ambition now is to integrate application processes for wider research governance approvals, that is to use the platform of the COREC form to develop a single form for REC, R&D, PIAG, GTAC and Medicines and Healthcare products Regulatory Agency (MHRA) application and to also develop systems to manage the application through these processes that maximise the use of electronic communications and facilitate the process for the researchers.
The implementation of the form will need careful management, communications, training and guidance. User testing must be extensive and a user group from a wide range of stakeholders will be required to test user acceptance.