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In this video I cover Most frequently asked questions in Clinical Data management
1) What are benefits of Clinical data management to Pharma industry?
Answer- CDM provides accurancy, precision and data consistency realistic data from clinical trails
2) Who is father of clinical trials
Answer- James Lind
3) What is meaning of clinical trials in healthcare industry?
Answer- Clinical research, clinical study, medical research
4) What is Clinical Trials?
Answer- Investigation on human beings to discover or verify clinical pharmacological and pharmacodynamic effect of product. They also check adverse reaction
5) Define unapproved therapeutic goods?
Answer- These are drugs which does not undergo clinical trails
6) What is IND?
Answer- Investigational New drug- Agent being tested in clinical trials
7) What is masking and single, double binding?
Answer- Masking- process of hiding details about research
Single binding- Subject is not aware of treatment
Double binding- Both researchers and subject is not aware of treatment
8) What is placebo effect?
Answer- It is inactive pill which isolate effect of study or treatment
9) What is included in patient file?
Answer- It includes patient demographic data , medical and treatment data
10) Explain preclinical studies
Answer- Animal study to study tolerance effect
11) What is validation procedure and how could you perform validation using data set?
Answer- Validation process applies for verifying specific output of programme generated from source programmer
12) How to perform validation for listing if it is of 400 pages?
Answer- Translate data with the help of PROC report and then use PROC COMPARE to compare data
13) How to generate listing, graphs and tables in SAS CDM?
Answer-with the help of PROC REPORT- translate listing
And with the help of PROC FREQ, PROC TRANSPOSE, PROC MEANS- to generate tables
And with the help of GPlot – to generate graphs
14) How to submit documents to FDA?
Answer- It needs PDF, XML format
15) What is SAS document
Answer- It is Statistical Analysis Software which include all comment, titles, programme header, footnotes to understand programme easily
16) What is CRT?
Answer- Case Report Tabulation
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Interview question answer in Clinical Data Management
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