Clinical Data Management

Post Graduate Diploma in Clinical Data Management

ACRI offers Post Graduate Diploma in Clinical Data Management in association with Quartesian. The CDM program is an industry integrated program wherein the students will undergo classroom training as well as mandatory internship in a leading U.S Based CRO



Course Duration : 4 months (1 month class room training + 3 months internship)

Modules
  • Drug Development Process
  • Introduction to Clinical Research
  • Types of Clinical Trials
  • Phases of Clinical Trials
  • History & Regulations in CR
  • ICH-GCP
  • IRB/IEC
  • Clinical Trial Protocol
  • Terminologies & definition of C.trials
  • Introduction to CDM
  • Study set-up
  • Introduction to Clinical Database
  • Documents, guidelines used in CDM
  • Data Entry
  • HANDS – ON TRAINING AS applicable
    PROJECT WORK (Clinical Study)
    As applicable
  • 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
  • PDP & Soft skills training
  • Job Interview Preparation
  • Mock Interview