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SAS CDM Online Training Course Content

Clinical Trails and Clinical Data Management : 

  • Phase trails: preclinical1,2,3 and 4
  • Drug discovery and development
  • ICH GCP
  • Computer system validation
  • 21 CFR 11
  • CRF designing
  • Pharmacokinetics
  • Pharmacovigilance
  • Clinical data management process
  • CDISC introduction
  • CTM systems
  • Data management plan

Sub Chapter

  • General abbreviated terms
  • Introduction to clinical trails
  • Responsibilities of CRA
  • Activities of CRA in house
  • CRA monitoring
  • Clinical trail monitoring
  • Responsibilities of PI
  • IRB
  • Informed consent form
  • ICH history
  • GPC guidelines
  • FDA history
  • FDA guidelines
  • IND,NDA reviews
  • Clinical research study document
  • CRF reviews and sample CRF’s
  • CRF data submission
  • CRF receiving
  • Introduction to SAS in CDM

Components of SAS Different data types

  • Base/SAS
  • SAS/STAT
  • SAS/Graph
  • SAS/ACCESS
  • SAS procedures
  • SAS Procedures
  • SAS Macros
  • SAS (working with sql)

Open clinical

  • Data base design
  • Protocol planning
  • CRF Data entry
  • Data management
  • Study planning
  • Study design
  • Oracle clinical (overview)