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)