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SAS VI – CDM Training

SAS CDM Training in Pune-Mumbai-Thane-online-classroom-classes. A clinical data management system or CDM is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDM. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data..

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SAS CDM Training in Pune

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)
Summary
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