Here, we derive the study visits according to the study window defined in the SAP, as well as re-grade the laboratory toxicity per protocol.
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SAS INTERVIEW QUESTIONS IN SDTM CODE
LABORATORY analysis dataset contains all subjects’ laboratory data, in the format of one observation per subject per test code per visit per accession number. The dataset has the format of one observation per subject. Q-6 Can you explain something about the datasets?ĭEMOGRAPHIC analysis dataset contains all subjects’ demographic data (i.e., Age, Race, and Gender), disposition data (i.e., Date patient withdrew from the study), treatment groups and key dates such as date of first dose, date of last collected Case Report Form (CRF) and duration on treatment. Q-5 How many tables, listings and graphs?Ĭan be in between 30-100 (including TLG’s). If the study is phase3 answer should be approx. If the study is phase2 answer should be approx. If the study is phase1 answer should be approx. Subjects are nothing but the patients involved in the clinical study.Īnswer to this question depends on the type of the study you have involved in. Generating the demographic tables, adverse events and serious adverse events reports.Analyzing the data according to the Statistical Analysis Plan (SAP).Creating the Statistical reports using Proc Report, Data _null_ and SAS Macro.
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SAS INTERVIEW QUESTIONS IN SDTM PDF
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What are the therapeutic areas you worked earlier?