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)