Certificate In Clinical Data Management

This course provides a comprehensive overview of Clinical Data Management (CDM), covering key processes, tools, and guidelines essential for clinical trials. Students will gain knowledge of CDM roles, data management plans, electronic data capture, database design, data validation, and the integration of AI and ML in virtual clinical trials.

Module 1 : Introduction of Clinical Data Management

  • The Clinical Data Management Process
  • Objectives of CDM
  • Roles involved in CDM
  • Introduction to CDM Tools/Softwares

Module 3 : Guidelines for Clinical Data Management

  • Documentation Scenario for Data Collection and Management
  • International studies and data privacy
  • Electronic source data in Clinical Investigations
  • Guidance for Industry- ISO, ICH, HL7, CDISC, CDASH

Module 5: Review and Finalization of study documents

  • Essential Documents before, during and after the trial_ICH GCP
  • Protocol
  • Informed Consent Documents
  • Investigator’s Brochure
  • Case Report Form
  • Clinical Study Report

Module 7 : Database designing (CRF and IXRS)

  • Purpose of CRF/IXRS
  • Regulatory requirements in designing the CRF
  • Techniques for Designing CRF/IXRS
  • Paper CRF vs. Electronic CRF

Module 9 : CRF Processing & Inventory from site

  • CRF Development Process
  • Component of CRF
  • Data Entry Status
  • Discrepancy Status
  • Colour coded response fields

Module 11 : Discrepancy Management

  • Tools for configuring discrepancy management
  • Reasons of discrepancies
  • Review status of discrepancies
  • Configuring the access status for discrepancies

Module 13 : QA/QC checks in CDM

  • Quality Control as per GCP
  • Quality Assurance as per GCP
  • Audit
  • The Quality assurance Group
  • Source data Review
  • Source data Verification

Module 15 : Tools for CDM

  • CDMS- Clinical Data Management Systems
  • EDC- Electronic Data Capture
  • CTMS- Clinical Trial Management System
  • ePRO- Electronic Patient Reported Outcomes
  • RTSM- Randomization and Trial Supply Management

Module 2 : Basics of Clinical Trials (Its Stakeholders : Roles and Responsibilities)

  • Investigator
  • Sponsor
  • Contract Research Organization (CRO)
  • Clinical Research Coordinator (CRC)
  • Clinical Research Associate (CRA)
  • Institutional Ethics Committee/IRB

Module 4 : Data Management Plan(DMP)

  • Introduction to DMP
  • Need of DMP in Clinical Research
  • Framework for creating a DMP
  • Purpose of DMP

Module 6: Electronic Data Capture

  • The Electronic Data Capture (EDC) system
  • Verification of EDC setup and implementation
  • User Acceptance Testing (UAT)

Module 8 : Data Entry, Data collection & CRF Tracking

  • Data entry systems
  • Data entry methods
  • Data Entry Guidelines
  • Data Entry Errors
  • Remote Data Entry and its benefits

Module 10 : Data Validation

  • CDM requirement in GCP
  • Data Validation Process during the conduct of a clinical trial
  • Validation steps performed by stakeholders (Investigator, Sponsor, Monitor, CDM team)

Module 12 : Database locking and Unlocking

  • Data management Procedure for database lock
  • Database lock process
  • Unlocking the database lock
  • Soft lock/Data cleaning
  • Hard lock

Module 14 : Data storage and Archival

  • What is data archiving
  • The benefit of data archival
  • Data archiving and data lifecycle management
  • Archiving for regulatory compliance

Module 16 : Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

  • E-Consent (Audio visual consent)
  • E-Patient Reported Outcomes (e-PRO)
  • IWRS
  • Telemedicine
  • Patient e Diaries
  • Remote Patient Monitoring

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure