In this doc we have the documentation about macros and program and E-records also.

Docs can be submitted to FDA using Define.pdf or define.Xml formats. 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.ДЁ)В Describe the data sets you have come across in your life?ДЄns:В I have worked with demographic, adverse event, laboratory, analysis and other data sets.Д©)В How would you submit the docs to FDA? Who will submit the docs?ДЄns:В We can submit the docs to FDA by e-submission. We would generate graph, using proc Gplot etc.Д¦)В How many tables can you create in a day?ДЄns:В 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.Д§)В What are all the PROCS have you used in your experience?ДЄns:В I have used many procedures like proc report, proc sort, proc format etc. Similarly we can create the tables by using PROC FREQ, PROC MEANS, and PROC TRANSPOSE and PROC REPORT. So in this condition we use PROC COMPARE to validate the listings.ДҐ)В How would you generate tables, listings and graphs?ДЄns:В We can generate the listings by using the PROC REPORT. To do this, we convert the listing in data sets by using PROC RTF and then after that we can compare it by using PROC COMPARE.Д¤)В Can you use PROC COMPARE to validate listings? Why?ДЄns:В 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. We can perform this validation for TLG by checking the output manually and for analysis data set it can be done using PROC COMPARE.ДЈ)В How would you perform the validation for the listing, which has 400 pages?ДЄns:В It is not possible to perform the validation for the listing having 400 pages manually. If this output is same as the output generated by the SAS programmerвЂ™s output then the program is considered to be valid. In this process validator write the program and generate the output. Phase 4:В The 4 phase study includes the post marketing studies including the drugвЂ™s risk, benefits etc.Дў)В Describe the validation procedure? How would you perform the validation for TLG as well as analysis data set?ДЄns:В Validation procedure is used to check the output of the SAS program generated by the source programmer. Phase 3:В 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:В 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:В Test a new drug or treatment to a small group of people (20-80) to evaluate its safety. 1) Describe the phases of clinical trials?ДЄns:В These are the following four phases of the clinical trials:

Clinical sas interview questions