Whatever we type in the program for making the program easily readable, easily understandable are in called as SAS documentation.ġ5. SAS documentation includes programmer header, comments, titles, footnotes etc. I would consider it as wrong in that type of situations I would contact the statistician. For example the dataset related to the menopause symptoms in women, if the variable sex having the values like F, M. If I have any doubt in values of variables in raw dataset I would contact the statistician.
If I have any problem regarding the programming I would contact the lead programmer. My project group consisting of six members, a project manager, two statisticians, lead programmer and two programmers. Tell me about your project group? To whom you would report/contact? This document also contains documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis.ġ3. Can u share your CDISC experience? What version of CDISC SDTM have you used?Īns: I have used version 3.1.1 of the CDISC SDTM.Īns:- This document contains detailed information regarding study objectives and statistical methods to aid in the production of the Clinical Study Report (CSR) including summary tables, figures, and subject data listings for Protocol. What are the docs do you submit to FDA?Īns:- We submit ISS and ISE documents to FDA.ġ1. Statistician or project manager will submit this doc to FDA.ġ0. In this doc we have the documentation about macros and program and E-records also. Docs can be submitted to FDA usingĭefine.pdf or define.Xml formats. How would you submit the docs to FDA? Who will submit the docs?Īns:- We can submit the docs to FDA by e-submission. Describe the data sets you have come across in your life?Īns:- I have worked with demographic, adverse event, laboratory, analysis and other data sets.ĩ. I have used proc report to generate the list report, in this procedure I have used subjid as order variable and trt_grp, sbd, dbd as display variables.Ĩ. What are all the PROCS have you used in your experience?Īns:- I have used many procedures like proc report, proc sort, proc format etc. How many tables can you create in a day?Īns:- Actually it depends on the complexity of the tables if there are same type of tables then, we can create 1-2-3 tables in a day.ħ. We would generate graph, using proc Gplot etc.Ħ. Similarly we can create the tables by using PROC FREQ, PROC MEANS, and PROC TRANSPOSE and PROC REPORT. How would you generate tables, listings and graphs?Īns:- We can generate the listings by using the PROC REPORT. So in this condition we use PROC COMPARE to validate the listings.ĥ. Can you use PROC COMPARE to validate listings? Why?Īns:- Yes, we can use PROC COMPARE to validate the listing because if there are many entries (pages) in the listings then it is not possible to check them manually. To do this, we convert the listing in data sets by using PROC REPORT and then after that we can compare it by using PROC COMPARE.Ĥ. How would you perform the validation for the listing, which has 400 pages?Īns:- It is not possible to perform the validation for the listing having 400 pages manually. We can perform this validation for TLG by checking the output manually and for analysis data set it can be done using PROC COMPARE.ģ. If this output is same as the output generated by the SAS programmer’s output then the program is considered to be valid. In this process validator write the program and generate the output. Describe the validation procedure? How would you perform the validation for TLG as well as analysis data set?Īns:- Validation procedure is used to check the output of the SAS program generated by the source programmer. Phase 4: The 4 phase study includes the post marketing studies including the drug’s risk, benefits etc.Ģ. Phase 3: The experimental drug or treatment is given to a large group of people (1000-3000) to see its effectiveness, monitor side effects and compare it to commonly used treatments. Phase 2: The experimental drug or treatment is given to a large group of people (100-300) to see that the drug is effective or not for that treatment. Phase 1: Test a new drug or treatment to a small group of people (20-80) to evaluate its safety. Ans:- These are the following four phases of the clinical trials:
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