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


About this company
Brainmeda is the best online institute We will provide the online trainings by certified professionals. Get certified with our well...