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  2. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    The first version of the TMF Reference Model (TMF RM) [5] was released in June 2010 and was updated in February, 2011 (v1.1) based on feedback provided by Regulators, and again in December, 2011 (v1.2), based on feedback provided by users of the model as they used it within their respective organizations to structure their paper and electronic ...

  3. Electronic trial master file - Wikipedia

    en.wikipedia.org/wiki/Electronic_trial_master_file

    An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

  4. Frameworx - Wikipedia

    en.wikipedia.org/wiki/Frameworx

    The Information Framework (formally Shared Information/Data Model or SID) is a unified reference data model providing a single set of terms for business objects in telecommunications. The objective is to enable people in different departments, companies or geographical locations to use the same terms to describe the same real world objects ...

  5. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting.

  6. Business Process Framework (eTOM) - Wikipedia

    en.wikipedia.org/wiki/Business_Process_Framework...

    The model describes the required business processes of service providers and defines key elements and how they should interact. The Business Process Framework (eTOM) is a standard maintained by the TM Forum , [ 1 ] an association for service providers and their suppliers in the telecommunications and entertainment industries.

  7. Business reference model - Wikipedia

    en.wikipedia.org/wiki/Business_reference_model

    A reference model in general is a model of something that embodies the basic goal or idea of something and can then be looked at as a reference for various purposes. A business reference model is a means to describe the business operations of an organization, independent of the organizational structure that perform them.

  8. Target operating model - Wikipedia

    en.wikipedia.org/wiki/Target_operating_model

    The target operating model is the "to be" model. It is possible to produce a target operating model for a business or a function within a business or a government department or a charity. There are many different frameworks identifying the components of a target operating model.

  9. International Plastic Modellers' Society - Wikipedia

    en.wikipedia.org/wiki/International_Plastic...

    The International Plastic Modellers' Society (often shortened to IPMS) is an international organisation of hobbyists interested in building plastic model kits. The Society is made up of national branches, and within these, local clubs who usually represent a town, city or locality. The first branch was established in the United Kingdom in 1963.