What is SDTM?
SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process.
Highlights of SDTM :
- SDTM Domains
- aCRF Desigining
- Trail Desigining
- Spec Desigining
- SDTM Conversions
- Validation
- Migration
- Submission
What is TLFs?
Tables, Listings and Figures plays vital role in SAS programming to display the data in a readable format to display the data in the form of Charts and Graphs which helps in Data Analysis.
Tables are created as per SAP(statistical Analysis Plan) document which is prepared to assist SAS programmers to detail on the scope of planned analyses, population definitions, and methodology on how prospective decisions are to be made for presenting study results.
Listings are the reports generated in the file formats like rtf,the difference between tables and listings is that listing does not involves any manipulation of data where as tables are derived from source data by applying different SAS procedures such as PROC SORT, PROC FORMAT, PROC TRANSPOSE, and PROC REPORT and transformed into a format as per SAP.
Graphs are prepared using procedures such as PROC CHART, PROC PLOT, PROC GCHART, PROC GPLOT,PROC SGPLOT, PROC SGPANEL, PROC SGPIE.
TLF’s helps in submission of Final document to FDA And sponsors.
Highlights of Course :
- Introduction of TLF’s
- Demographics
- Adverse Event
- Dispostion
- Conmed
- Vitals
- Lab
- Working with 2 Graphs
Software Installation : Currently software installation is a paid one. You need to do it from system administrator. The total software which consists of around 17 Gb. It will take 2 Hours to do the installation. For SDTM there is no software you need use SAS for SDTM Programming.
System requirements :
Processor : i3 and above
RAM : 4GB and above [preferable 8 GB Best ]
Harddisk : SSD Harddisk with 250 GB OR Above / other harddisk also its ok
Target Audience : To do these SDTM Course you need have the knowledge on
- Base sas
- Advanced SAS
- Clinical Reseach just basic knowlegde
Materials : Books and Daily notes will be provided by us along with that recording also will be provided for reference . Step by step notes will be provided and excersises also.
Sample Videos : We request you that first don’t join the course directly as we provide the sample videos in the cirriculam first watch that try to understand. If you understand and feel comfortable with trainer explanation then gohead for classes. Join the course.
Working hours : 9:00 am ist to 8 pm ist .