Clinical Trails and Clinical Data Management (Duration: 40 hrs)

Introduction
Drug discovery and development
Phase trails: preclinical1,2,3 and 4
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)