TOPICS

SAS CDM  Training Concepts :

Clinical Trails and Clinical Data Management :
✔Phase trails: preclinical
✔Drug discovery and development
✔ICH GCP
✔Computer system validation
✔ CFR
✔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).