Training in Clinical Data Mananagement
Brainmeda - New York, NY

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Course Content for Clinical Data Management Training:

  • Drug Development and Clinical Trial Phases
  • Fundamentals of Clinical Research & Roles in a CRO
  • Clinical Data Management Process & Life cycle
  • ICH – GCP guidelines & 21 CFR Part 11 regulations
  • GCDMP guidelines
  • CDM Process in detail
  • Paper Vs Electronic Data capture
  • Data Management Plan document
  • Clinical Study Documentations Setup

o CRF Annotation
o Creation of SDTM annotated CRF
o Creation of Edit Check Specification Documents
o Study User Acceptance Test (UAT) documents

  • Project Initiation
  • CRF Design/ eCRF design
  • Discrepancy Management
  • Query handling
  • Coding
  • SAE
  • Study Close and Lock
  • Questions and Discussions

Practical Training of Oracle Clinical Database End user Course content:
Module 1:

  • Study Design Overview
  • Program , Project and Organizational unit
  • Regions and Planned studies
  • Easy Study design

o Patients

  • Investigators, Sites and Study - Site – Investigator – Patients assignments.
  • Patient Enrollment and Test a study design.
  • Questions and Discussions

Module 2:

  • Test data entry.
  • Validation programming / Edit check programming.
  • First pass, Second pass data entry, Update, Browse and key changes.
  • Questions and Discussions

Module 3:

  • Data Entry
  • Discrepancy Management
  • Batch Validation
  • DCF Management
  • Questions and Discussions

Module 4:

  • Database Freeze & unfreezing
  • Study Database Lock
  • Data Transfer Process
  • Data Extract - Oracle views
  • Questions and Discussions

Module: 1,2,3,5 are the Job responsibility of the Clinical database Programmer & Module 4 is responsibility of the Clinical Data Analyst.
Software used for training is Oracle Clinical 4.6.6

For more information, please contact at training at brainmeda.com
Visit www.brainmeda.com for more information.
Brainmeda Advantages:

  • Hands on live projects
  • Industry SOPs based training
  • Trainers with minimum 5 years experience
  • 24 hours access to application lab

Access to Oracle Clinical 4.6.6 Software