IRAS
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Dear Colleague Version 3 of the Integrated Research Application System (IRAS) was released earlier this month. This version provides new improved functionality for studies involving investigational medicinal products (IMPs). IRAS continues to provide a user friendly system for capturing data on an HSC research study and generating the necessary application forms - avoiding the need for duplicate data entry on multiple systems. However, version 3 can generate an application to the Medicines and Healthcare products Regulatory Agency (MHRA) for IMPs. Researchers need only go to EudraCT website to obtain their EudraCT number. Researchers requiring permission to conduct research within the HSC should use IRAS and submit the R&D Form generated by the system, along with the Site Specific Information (SSI) Form, to the relevant HSC Trust(s). From 1 April 2009 Site Specific Assessments will be carried out by HSC Trusts rather than through the ethics system. After 01 April 2009 ORECNI will not accept an SSI and this must be sent directly to the relevant HSC Trust. In order to build on the potential for streamlining provided by IRAS all five HSC Trusts are now working under a common memorandum of understanding to consolidate common working arrangements. Under this new system, where a research study involves more than one HSC Trust, a single lead Trust takes responsibility for sign-off on a specific set of generic issues and generates a Governance Report on behalf of all participating trusts. Site specific issues are considered by the other non-lead Trust(s) in parallel, where possible, before final permission is granted. A booklet providing information on version 3 of IRAS is attached above in a PDF format. A hard copy will be included with the next issue of R&D Today. Copies should also be available from HSC Trust Research Offices. With kindest regards HSC R&D Office |