SAS Clinical Data Management online training course content concepts :
Clinical Trails and Clinical Data Management :
1.Phase trails: preclinical1,2,3 and 4
2.Drug discovery and development
3.ICH GCP
4.Computer system validation
5.21 CFR 11
6.CRF designing
7.Pharmacokinetics
8.Pharmacovigilance
9.Clinical data management process
10.CDISC introduction
11.CTM systems
12.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)
