SAS CDM

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)