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

IGMPI

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

Eligibility

Any Graduation/ B.tech/ 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).

Registration

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:
info@igmpi.ac.in / 18001031071 (Toll Free) , Phone:+91 11 26512850