Clinical Research course for Novice by Lara Tech

Course Content:

Phase Trials1,2,3,4
ICH-GCP
Clinical Trial Process
BA,BE Studies
Responsibilities of Clinical Research Persons
PK,PD
CTMs
Regulatory Bodies(FDA,IRB,NDA)
Clinical Research Documents

Clinical Data Management(Especially Present Industry Expected)
protocol
understanding Of Protocol
Electronic CRF Designing
Edit Check Programming
Edit Checks Implementation
Data Base Design
Data Validation
Data Base Setup
Data Cleaning
QC and QA
UAT Process
Importance of CDM
21 CFR 11
Clinical Data Data Management Process
GCDMP
EDC (Electronic Data Capture)
EDC Plan
DMp

Pharmacovigilance
SAS programming

Base sas
and Advance Sas