CDISC SDTM 3.3
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
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 .
SDTM : Study data tabulation model
Introduction to Clinical
21 CRF Part 11
Clinical Research Methodology
Purpose of Trail designing
TA :Trail Arm
TV : Trial Visits
TI : Trial Inclusion/Exclusion Criteria
TE : Trial Elements
TD: Trial Disease Assessment
TM: Trial Disease Milestones
SDTM Domain in-depth domain explanation and programming conversion Techniques
Models for Special Purpose Domains
SV Subject Visits
Models for Interventions Domains
CM Concomitant and Prior Medications
Models for Events Domains
AE Adverse Events
Findings About Events or Interventions
Findings About Events or Interventions FA
Models for Findings Domains
LB Laboratory Test Results
Cardiovascular System Findings (CV)
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