(3)The User acknowledges that devices, non-compliant with the approved modalities specification as detailed above, will not be certified.
Upon termination of the User Agreement between the User and MRT, the User shall immediately cease the use of the e-PRO and shall destroy any material related to the e-PRO in the system by erasing them from the magnetic mediate on which they are stored and certify in writing that they have been destroyed. mobile device cannot access the Web versions or a disclaimer should be stated otherwise. Participants provided responses to the HD-PRO-TRIAD and other HRQOL and disease severity instruments (EuroQOL 5D, Short Form 12, Neuro-QOL Item Banks, PROMIS Global Health, and self-reported Unified Huntington's Disease Rating Scale Total Functional Capacity and Independence Scales). (2)Web versions should only be authorized for screens of 1024px or larger, i.e.
(1)for password protected clinical trial projects only. Please do make sure to consider the target population when selecting a device for a specific study. the “Original electronic Versions” (“OeVs”) of the Questionnaire).Į-Booklet Current Version: SMAIS_e-Booklet_1.0 It includes instructions and checklists on instrument properties and configuration, content, navigation, workflow diagram, format and provides a model about how the electronic version of the Questionnaire must be displayed (i.e. The Questionnaire e-Booklet, developed in collaboration with the Owner, is intended to accompany the User through the development of official, validated, and approved electronic versions of the Questionnaire. The review of target language screenshots is mandatory and should be performed exclusively by the Authors This work is subject to a specific budget The review of target language screenshots is not mandatory but can be performed by Mapi/ICON. The review of target language screenshots is mandatory and should be performed exclusively by Mapi/ICON. If applicable for a specific scope and budget, after implementation of the SMAIS into the device(s), the User and/or eCOA Company will provide Mapi/ICON with a test device or the on-line connection, in order to assess the overall usability of the solution, with the target patient population(s) in mind including clarity, navigation, font size, and device usability. Usability testing of the original version performed by Experts: The review of the screenshots is mandatory and should be performed exclusively by the Authors The review of the screenshots is not mandatory but can be performed by MRT. The review of the screenshots is mandatory and should be performed exclusively by MRT. Screenshots review of the original version: The work performed can be certified once it has been confirmed as being in line with the instructions of the SMAIS e-Booklet. Please submit a request.Ĭonditions to Implement in Electronic Applications
A license agreement must be completed and a user fee is required by all users (commercial & academic users) and a screenshot review agreement must be signed by commercial users.