VITAL SIGN analysis dataset captures all subjects’ vital signs collected during the trial. SAFETY can be categorized into four analysis datasets: This dataset has the format of one record per subject per analysis period. In addition, this dataset can contain other efficacy parameters of interest, such as censor variables pertaining to the time to an efficacy event. If the laboratory data are collected from multiple local lab centers, this analysis dataset will also centralize the laboratory data and standardize measurement units by using conversion factors.ĮFFICACY analysis dataset contains derived primary and secondary endpoint variables as defined in the SAP. For a crossover study, both the visit related to the initial period and as it is related to the beginning of the new study period will be derived. 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.
#Sas interview questions pdf 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.Performing data extraction from various repositories and pre-process data when applicable.
#Sas interview questions pdf pdf#
Here are some more details you need to lay down in front of him…Ī) Is it a single blinded or double-blinded study?ī) Is it a randomized or non-randomized study?ĭ) Safety parameters only (if it is a phase-1)Į) Safety and efficacy parameters if the study is either Phase-2,3or 4. You also need to tell about the name of the drug and the therapeutic area of it. Q-2? Can you tell me something about your last project study design? If the interviewer asked you this question, then you need to tell that your current project is on a phase-1 study (or phase-2/Phase-3). central nervous system,Neurology,Gastroenterology,Ophthalmology, Orthopedics and pain control,Pulmonary,Vaccines,Dermatology,Gene therapy,Immunology etc… therapeutic areas a pharmaceutical company can work on and few of them include, anti-viral (HIV), Alzheimer’s, Respiratory, Oncology, Metabolic Disorders (Anti-Diabetic), Neurological, Cardiovascular. What are the therapeutic areas you worked earlier?
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