Advanced Post Graduate Diploma in Clinical Research, Clinical Data Management & SAS

Module-I•Clinical Research Introduction•Principles of Pharmacology & Drug Discovery & Development•Roles & Responsibilities of Key Stakeholders•Preparations & Planning for Clinical Trials•Essential Documentation in Clinical Research & Regulatory Submissions•Clinical Trials Project Planning & Management•Study Start up Process
•Clinical Monitoring Essentials•Compliance, Auditing & Quality Control in Clinical Research•Overview of Clinical Data Management & Biostatistics
Module IIClinical Data Management•Introduction to Data Management•Study Set Up•CRF Design Considerations•Identifying and Managing Discrepancies•Medical Coding•Database Closure•Clinical Database &Types•Data Management Plan•Electronic Data Capture•Tracking CRF Data•Managing Lab Data•Collecting Adverse Event Data•Creating Reports and Transferring Data•Enterprise Clinical Data Management Tools
Module IIIClinical Data Analysis and Reporting Using Clinical Data Management Software•Study set-up•Introduction to Clinical Database•Documents, guidelines used in CDM•Data Entry•Data Review/Data Validation, Query Management•Database QC•CRF Design (Introduction)•Database Design (Introduction)•Edit Check & Edit Check Testing•UAT (User Acceptance Testing)•SOPs•Quality Assurance, Audits
Module IVBasic SAS PROGRAMMING• Getting Started with SAS•Components of SAS•Reading various types of Raw data•Working with SAS Datasets•Combining datasets•Working with SAS Arrays•Proc SQL•SAS Macro Language•Basic Statistical ProceduresEntry Level Career Options Upon Completion of the Program:•Clinical Research Co-coordinator•Clinical Research Associate•Clinical Trail Assistant•In-house CRA•Team Lead•Project Manager, Senior/Project