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Conditions for using questionnaire definition files
As described elsewhere, one of the main purposes of this project is to spread quality of life measurement among the medical community.
The questionnaire definition files you find here, can be downloaded for use with the Quality-of-Life-Recorder. No matter how closely resembling any published paper questionnaire any of these questionnaire definition files may be designed, their existence or availability does not automatically grant the right to use any published questionnaire or questionnaire concept in any kind of study or for another purpose, if any copyright owner's rights would be affected. In some of the questionnaire definition files, you may find a copyright notice and history documentation for the concept of the questionnaire as well as for the questionnaire definition file, which you can display through AnyQuest's "Help"-menu.
Before you may use certain quality of life questionniares, you are obliged to contact their respective copyright owners to find out about their policies.
In no case do the available questionnaire definition files claim to be perfect or officially authorized adaptions of the paper questionnaires they resemble.
Software and additional ressources on this web-site do currently NOT attempt to fulfill requirements set out by legislation applicable for "medical products" e.g. as repeatedly laid out and extended by some people in the EU - for the simple reason that the Quality-of-Life Recorder concept and its software components are intended to provide a platform, standard software or toolkit, similar to e.g. Microsoft Excel, OpenOffice, SPSS, SAS etc. - rather than a single medical product.
By means of the included editor, computation language for flow control and computation of results, and a variety of configurable interfaces, this platform is extremely versatile and allows for an unlimited and unforeseeable number of actual applications or configurations.
At the same time, the allocation into any of the available risk classes would largely depend on the intended usage at any location; and the rules for this classification are (as in most recent laws) not unequivocal: In the EU, a QL-Recorder completely configured for a given application might - depending on the intended use and interpretation of the rules - either be no medical product at all, or be a medical product from any risk class between I and III. According to FDA rules, it might fall into the "gray area" between medical products and non-medical products.
While even the costs for certification of a single application or configuration would quite probably exceed the possibilities of the shareware approach of this project, an attempted certification of multiple or even an unlimited number of possible configurations is plainly impossible - either due to the practical shareware setting, or simply from mathematical considerations. This would be similar to someone attempting to certify MS Excel or SAS or Mozilla Firefox (or even Microsoft Windows or Linux itself) as medical products - and then again, every single table or script to be used with these programs in a clinical or medical research setting, before they could e.g. use a table to compute BMIs or a script to evaluate data collected for medical quality management.
Special rules may apply when the QL-Recorder is used in research settings, where informed consent is obtained, or where QL-Recorder configurations are created and installed by or in collaboration with a local IT team.
Recent legislation, however, of institutions, to whom certain states with defective democracies have outsourced their government obligations, has become notorious for generating very large works with very questionable feasibility for real life causing equally large legal uncertainty. Therefore, the following conditions apply to any of my offerings:
The tools and methodology described or provided on this site are definitively NOT offered to anybody who is located in an area or a setting, or who represents someone located in an area or a setting, where the provision or the use of these tools or methodology might violate locally applicable legislation.
Each prospective user of the tools and methodology is responsible to first determine whether their intended use would be legal in their individual setting - and if necessary, to ensure that any legally required overhead be fulfilled as required at their local setting for their locally intended application.
If required, a certification as a medical product of any given configuration specifically created for one project can be obtained within that project according to locally applicable regulations regulations, if all ressources required for this process are covered for by that project (i.e. staff, fees etc. - for months or for up to several years or decades, depending on the determined risk class, depending on the intended application...).
Please observe additional information on legal issues available under "Contact - Imprint - Data protection".
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