![]() OK, now you have made your client curious and they will ask you to give an idea, how this could be accomplished. How would you respond? Something like, well, that is a challenge and I gotta ask my service colleagues ?! - Ha, no - hopefully something like “Sure, we can!” A folder substructure to organize the dossier’s documents.Properties like customer name, customer number, company.Technically the top level folder “John Smith” represents the dossier. The picture above shows the dossier of customer John Smith. The basic idea of a dossier is to get a structured view of the documents in your repository according to a primary order principle like, all documents of a customer or all documents of an employee etc. The client asks if ICN can cope with that requirement and asks you to provide a user interface similar to the following – What would you respond? And the client responds: Well, that’s really nice, but our end users are used to work with special views on the documents of our customers, that we call customer dossiers. Imaging you go to a client and make a presentation about IBM Content Navigator, telling them great stories about an excellent cutting-edge user interface experience. Imagine you have to build a Dossier Management solution (in German word: Aktenverwaltung) – Can you do this with ICN? – Yes, you can! – If you don’t know how or you just want to see a compelling sample of how easy and fast ICN can be extended and adapted to get a new custom solution, keep reading…. It is also a framework which enables you to customize and extend standard functionality. IBM Content Navigator (ICN) is a ready to use state-of-the art user interface for enterprise content management (ECM) solutions. He holds a Master Degree in Computer Science of the University of Ulm. Rainer has been with IBM for three years and previously worked for IBM FileNet Business Partners for seven years. He has ten years of software engineering experience in the ECM field including consulting, design, development, installation and integration with strong focus in client development for ECM systems. If the review committee has already assessed an earlier version of the IMPD in the context of another clinical trial, please state this in the cover letter and submit a summary of changes and a track changes version of the IMPD.Rainer Mueller-Maechler is a Senior IT Specialist with IBM Software Group in Zurich, Switzerland. Table 1 states the minimum information on the medicinal product which you must submit for review. It is important that the research file for the review committee contains sufficient information on the medicinal product being used in the research so that it can reach an informed decision on the safety and vailidity of the research. SPC texts for many medicinal products (summary product characteristics, IB-1 text) may be found in the Medicines Information Bank of the Medicines Evaluation Board. If a product is authorised and will be used in the licensed form, an SPC (summary of product characteristics) will suffice, if it is available. See also the template Investigational Medicinal Product Dossier (IMPD) and the accompanying explanatory notes. The requirements of the IMPD are mentioned in paragraph 2.7 of the CT-1 directive ‘Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial’. Download the template IMPD Efficacy and Safety Requirements
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