SDTM stands for study data tabulation model.it is very useful in the clinical and non-clinical trials’ concept was developed by CDISC (The clinical data interchange standards consortium).it is nonprofit organization which deals with medical research data.
The idea of invention new drugs, undergoes various phase and generate lot of data which was submitted to USFDA regulatory, finally approval was get done by this regularity, apart from that reviewers spent huge amount of time trying to get data into standard format rather than reviewing the generated data. Ultimately it will take long time for completion also it too complex.
For avoiding this CDISC develop the SDTM concept for better understanding and smoothing process which clear description of the structure, attributes, content of each data set and variables submitted as part of your clinical trials. There are standard variables and standard data set name which are easily identified by reviewer. Entire implementation guide is available in CDISC website and latest version is SDTMv2.0.
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