Emerson 406A154H01 Central Control Module

Emerson 406A154H01 Central Control Module

Brand: Emerson

Module: 406A154H01

Description: Central Control Module

Country: USA

All the TLFs generated to support ePRO analysis will make use of ADaM datasets. To support this analysis, three individual ADaM datasets (ADPRO (Analysis Dataset for PRO), ADTTD (PRO Time-toTrue-Deterioration) and ADPLDA (Analysis Dataset for PRO Longitudinal Data Analysis) are developed and conformed to ADAM IG 1.1 and belong to the class of BDS (Basic Data Structure). Implementing ADaM compliant (in this case BDS) is essential to the Clinical Data Interchange Standards Consortium (CDISC) compliance of total submission package. However, implementing BDS datasets especially the Questionnaire data is quite challenging. To guide and create mentioned datasets, programmers typically follow company specific dataset specifications which is usually in excel format. Common subject level variables (Core variables) are carried from Subject Level Analysis Dataset (ADSL) to all the datasets, similarly core variables are also carried to ePRO related datasets, besides we also carry important variables such as disease progression date etc from other efficacy datasets to support further analysis.

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