SAS Course Content
Statistical Analysis System, is a software suite developed by SAS Institute for advanced analytics, business intelligence, data management, and predictive analytics. It is the largest market-share holder for advanced analytics.
Professional training on Clinical Research, CDSIC SDTM and SAS
for all life science graduates.
Training Featurs :
- Training is designed as per the Industry Requirements in the market.
- Training is provided by the real time faculty with a project.
- Duration: 2 months (120 hours).
- Training includes Study material, Project and 100%* Placement support.
- Training is available both off line (classroom) and online.
- Drug Discovery and Development Process
- Introduction to Clinical Research
- Ethics considerations on Clinical Research
- Ethics Committee and IRB/IEC
- Overview of ICH-GCP Guidelines
- ICMR Guidelines
- Essential Documents
- Protocol Design
- Clinical Trial Design
- Sponsor Responsibilities
- Responsibilities of Investigator
- Site Initiation Visit (SIV)
- Drug Accountability
- New Drug Application Submission (NDA)
- Scheduled-Y Application
- Study Coordinators (CRA/CRC)
- Site Close-out
- 21 CFR PART11
(Study Data Tabulation Model)
- What is CDISC and Standards?
- What is SDTM?
- Types of variables and core values
- Basic structure of the domains
- Brief Explanation about all the domains in SDTM IG
- Difference between SDTM IG 3.1.2v and 3.1.3v
- Standard domains vs. custom domains
- Controlled terminology and QS scales
- A Real time Practice on SDTM Mapping Specification.
- What is CRF annotation (Practice on aCRF)
- Generating the standard CRT Tables by SAS.
- MedDRA and WHO DRUG standards
- Introduction to OpenCDISC and Report?
- Generating SAS and .XPT files?
- What is define.xml and define.pdf?
- What is Reviewers guide?
- Required Documents for FDA submission