Emerson KJ4002X1-BF1 Output Module

Emerson KJ4002X1-BF1 Output Module

Brand: EMERSON

Module: KJ4002X1-BF1

Description: Output Module

Product Orgin: USA

ll 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. Since this is QS data, all the questions that are mapped to QSTESTCD/QSTEST variables in SDTM/QS domain are directly mapped to paramcd/param of ADPRO. Along with directly mapped parameters, additional parameters are derived to support intended analysis. Following paragraphs describes each of the analysis datasets (ADPRO, ADTTD and ADPLDA) in detail.

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