SAS CLINICAL
We provide the best SAS Clinical /Clinical SAS training with the Clinical knowledge which always have an competitive edge over a purely SAS programmer as he/she will be in a position to take decisions while programming whose primary responsibility is writing programs in SAS to generate the output (tables, listings, and figures) needed for the analysis and reporting of the clinical study. A familiarity with Clinical SAS Programmer having CDISC (standard specifications for electronically submitted clinical data) expertise would have extensive opportunities.
SAS CLINICAL Course content
Clinical Data Management(CDM-Oracle clinical Database)
Syllabus (Clinical Research & Clinical Data Management):
Introduction to Clinical Research and Clinical Data Management
Introduction to Oracle Clinical Database
Different Phases of clinical trials
INDA, NDA Applications
ICH-GCP Guidelines
Responsibilities of Clinical Trial Team
Protocol and Informed Consent Forms
Clinical Data Management Process and Life cycle
Data Management Plan
Case Report Forms, Types of CRFs
Designing of CRFs
CRF Annotation
Data Capture Methods and EDC
Data Entry – First pass and Second Pass Entry
Edit Check Specifications
Data Validation Procedures
Discrepancy Management
Data Clarification Forms (DCFs)
Database Locking and Freezing
Data Coding and Medical Dictionaries
SAE Reconciliation
Oracle Clinical Database Syllabus
Introduction to OC window
Subsystems in OC
Defining Programs and Projects
Defining Organization Units
Defining Regions
Defining Planned Studies
Easy Study Design
Creating Intervals
Creating Events
Creating Investigator, Site Records and Assignments
Creating Patient Positions and Assignments
Creating Questions
Creating Question Groups
Creating and Maintaining DVG's
Creating DCM's, DCI's & DCI Books
Test a Study
Test Data Entry
Initial Login
Key Changes
First Pass Entry
Second Pass Entry
Comparison Reconciliation
Update
Browse
Patient Enrollment
Data Validation(Batch validation)
Discrepancy Management
Data Clarification Forms (DCFs)
Locking and Freezing
RDC (Remote Data Capture):
Data entry in RDC
Discrepancy Management in RDC
CRFs in RDC
