ABSTRACT : Data transfer specifications (DTS), drafted by the data management team, carries information on how the non-CRF related raw data should be transferred for integration with clinical study database. The specifications are finalized after due feedback from the biostatistics, vendors, and the programming team. With the advent of decentralized trials and increase in device data, DTS hold a potential to not only define a dataset but also a potential to delay the go live of a clinical trial if the trial transfers are not carefully tested in time. In this paper, we will discuss the general contents of DTS and what aspects of DTS are to be reviewed from programming standpoint with few examples. This paper will also discuss about certain approaches on pre-programming activities to map data not only as per CDISC SDTM standards but also from analysis standpoint to make data mapping easier on receipt of live raw data. INTRODUCTION: Significant amounts of data...
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STUDY START UP/STUDY SET UP: eCRF(case report form): The case report form is a printed or electronic questionnaire for collecting data from study participants and reporting it to trial sponsors. The document is created specifically for each research project in accordance with the trial protocol, and recommendations of the Clinical Data Acquisitions Standards Harmonization (CDASH). They are developed by Clinical Data Interchange Standards Consortium to streamline industry-wide data exchange. Say, CDASH dictates dd/mm/yy format for collecting dates. (Read our article on CDISC standards to learn more.) Well-designed case report forms collect only data necessary for the particular study avoiding any redundancy. The fields to be filled in may include demographics (age, gender), basic measurements (height, weight), vital signs (blood pressure, temperature, etc.) captured at various time points, lab exams, medical history, adverse events, and more, based on the research requirements....