Short Term Program in Clinical Data
Management and Oracle Clinical

Overview

Clinical Data Management is a rapidly growing industry and requires trained professionals in the cross functional domain of Bio-IT. The Certificate in Clinical Research Management is designed to provide extensive training in the niche domain of clinical research and clinical data management.

Syllabus

1. Clinical Research

  • Introduction to Clinical Trials, Good Clinical Practise, ICH E6 & FDA Regulations
  • Roles and Responsibilities (RAR), Institutional Review Board (IRB) – Basic, Institutional Review Board (IRB)- Advanced
  • Informed Consent (IC), Health Insurance Portability & Accountability Act (HIPAA), Recruitment & Retention in Clinical Trials
  • AE Reporting in Clinical Trials, Drug Inventory Management, CRC Site Closeout, FDA Site Inspection

2. Clinical Data Management

  • Introduction to Clinical Data Management, Data Management Plan
  • Standard Operating Procedures, Clinical Data Management Documentation Overview
  • Forms Management Data Privacy, GCDMP, 21 CFR Part 11, HL7, and HIPAA Standards
  • Trials Metrics, Database Closure

2. Oracle Clinical Trial

  • Oracle Clinical Overview, Navigation and Subsystems Planning, Designing a Study
  • Global Library – DVGs, Questions and Question groups, Definition Subsystem – DCMs and DCIs, Generating Data, Entry screens
  • Validation and Derivation, Procedures and Production Data Entry OC Module 4: Discrepancy and DCF Management

Course Date

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Campus Visit

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