Post Graduate Diploma/Executive Diploma in Clinical Data Management (CDM)


Clinical data management (CDM) is the field which transforms raw data into consistent, accurate, reliable, meaningful trial output at a fair price. It aims to ensure data quality, integrity, and compliance with protocols and regulations. Clinical research employs a technique of Clinical data management to provide reliable and high quaity data from clinical trials. CDM makes sure that the study’s findings are supported by data that has been collected and stored. Rising number of clinical trials worldwide is anticipated to drive steady growth in clinical data management systems (CDMS) market by 2030. CDM market size is valued at 2164.88 Million in 2022 and this is predicted to increase to 6399.82 Million by the year 2031 at a 13.2% CAGR during the forecast period for 2023-2031.

Market growth is likely to be boosted by the expanding healthcare sector and the rapid advancements in the pharmaceutical industry. Product adoption has been driven by the increasing use of clinical data management systems by CRO’s and medical device manufacturers to maintain track of clinical data. Pharma Company’s needs effective data management for stringent process assurance, which helped the clinical data management systems market grows favourably in recent years. Trusworthy clinical trial data reduce cost, time and risk.

Market Segmentation

The Clinical Data Management Systems Market is segmented on the basis of Delivery Mode and End-use. Based on Delivery Mode, the market is segmented as Licensed Enterprise Solutions, Cloud-based Solutions, and Web-hosted Solutions. Based on End-use, the market is segmented into Contract Research Organizations, Medical Device Companies, and Pharma/Biotech Companies.

The Cloud Segment Is Accounted As A Major Contributor In The Clinical Data Management Systems Market. With the introduction of Virtual Clincal trials, the cloud segment's market share will rise. The cloud based technique provides better data management, a lower chance of data loss, and less concern for regulatory compliance. This will lead to increasing demands of cloud- based solutions by organizations.

Professionally trained personnel are required to sustain in such challenging environment. IGMPI provides theoretical as well as practical knowledge which provides assurance of sustainability and success in this industry. The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Data management as their career choice. The major Key Players are ORACLE, IBM, CLINDEX, Ennov, Clinical, Veeva.

Programme Modules

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 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 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 4: Data Management Plan(DMP)

  • Introduction to DMP
  • Need of DMP in Clinical Research
  • Framework for creating a DMP
  • Purpose of DMP
  • 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 6: Electronic Data Capture

  • The Electronic Data Capture (EDC) system
  • Verification of EDC setup and implementation
  • User Acceptance Testing (UAT)
  • 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 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 9: CRF Processing & Inventory from site

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

  • Tools for configuring discrepancy management
  • Reasons of discrepancies
  • Review status of discrepancies
  • Configuring the access status for discrepancies
  • 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 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 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 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 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
  • Module 17: Industry Based Case Studies


    Any Graduation/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

    Programme Duration

    The duration to complete this programme is 1 year (Post Graduate Diploma) and 6 months (Executive Diploma).


    The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

    Programme Deliverables

    A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

    • – Assignments for all the programme modules for continuous evaluation and guidance.
    • – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
    • – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
    • – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
    • – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
    • – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
    • – All learning and training delivery initiatives shall be conducted in English.

    Examination & Certification

    IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma and Executive Diploma. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

    All the participants are obliged to appear for an online proctored exam at the end of the programme. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Clinical Data Management, by IGMPI. For all the above-mentioned modules elaborate programme material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the web page as well.

    Placement Assistance & Corporate Relations

    The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

    In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like PPD, Infosys, The Emmes Company, Aster Zeneca, MPREX Healthcare, IQVIA, Syneos Health, Parexel, PRA Health Sciences, ICON, Labcorp, Tata Consultancy Services, Accenture, Cognizant Technology Solutions, Novartis, Syneos Health, Novo Nordisk, Indegene, iMedglobal, Lotus Labs, Aris Global, ClinicVA Healthcare Solutions, Accenture, Apollo Hospital, Bayer, Eli Lilly and Company, Ranbaxy, Genpact, GlaxoSmithKelvin, Infosys, The Emmes Company, Astra Zeneca, MPREX Healthcare, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

    Future career prospects

    Clinical Data Management (CDM) has long way with increased importance within and outside biopharmaceutical research and development. Specific skills include the development of electronic case report forms, data management plans, data review and reconciliation. Major companies hiring clinical data management professionals are CTS, TCS, PPD, BMS, Pfizer, Accenture, ICON, Novartis, Quintiles, Parexel, Neeman Medical etc. This programme provides person, professional benefits such as sense of accomplishment, validation of CDM knowledge, recognition by company, ability to train others as well as assisting others and organizational benefits such as well trained and updated professionals, excellent professional development opportunities with increased efficiency and improved quality within the company. Not only in India you have scope in U.S., Canada, U.K., Germany, China, Japan, Brazil, Mexico, South Korea, South Eaast Asia.This programme ensures a professional career in the clinical research industry as a Case Report Designer / Clinical Data Quality Assurance/ Quality Control/ Clinical Data Associate, Team Lead, Project Managers in pharmaceutical/biotechnology sectors, CROs, etc.

    View Prospectus

    Programme Fee Details

    How to apply

    For further enquiries, write to or call us on: / 18001031071 (Toll Free) , Phone:+91 11 26512850

    Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

    Placement Testimonials

    All existing and old students and training participants are requested to write to our Corporate Resources division on along with your updated resume mentioning their Enrollment No. for registration with our Placement Cell asap, if not registered yet.

    Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

    Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

    Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

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    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like