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Clinical Data
Management

Transform raw clinical trial data into accurate, consistent, and regulatory-compliant results — the backbone of evidence-based drug development.

📋 CDISC / CDASH 🔒 ICH / GCP ☁️ Cloud-Based CDM 🗄️ EDC Systems
6–12 Months
Online Live Classes
Registrations Open
Data Integrity· EDC Systems· Database Management· Regulatory Compliance· Quality Assurance

About Clinical Data Management

Clinical Data Management (CDM) is the field that converts raw clinical trial data into accurate, consistent, reliable, and meaningful results in a cost-effective manner. Its primary goal is to maintain data quality, integrity, and adherence to study protocols and regulatory requirements.

In clinical research, CDM ensures that data generated from clinical trials is dependable and of high quality — guaranteeing that study conclusions are based on properly collected, managed, and stored data.

Ensures data quality, integrity, and protocol adherence throughout trials

Cloud-based CDM solutions dominate the market, driven by virtual clinical trials

High demand for skilled CDM professionals across CROs, pharma, and biotech

Comprehensive training from data collection to database lock and archiving

Market Overview & Industry Players

The CDMS market spans cloud, licensed, and web-hosted solutions across CROs, pharma, and device companies

☁️

Cloud-Based

Dominant delivery mode — lower data loss risk, simplified compliance

🏢

Licensed Enterprise

On-premise systems for large pharmaceutical organisations

🌐

Web-Hosted Solutions

Accessible, scalable platforms for CROs and device companies

Key Industry Players in CDM

Oracle IBM Veeva Medidata Solutions IQVIA Parexel ArisGlobal OpenClinica Saama Technologies

Programme Curriculum

17 progressive modules covering the full clinical data management lifecycle

1

Overview of Clinical Data Management

Role of CDM, end-to-end data lifecycle, key objectives, and tools

CDM Lifecycle CDM Objectives CDM Software
2

Clinical Trials & Key Stakeholders

Roles of investigators, sponsors, CROs, CRAs, and ethics committees

Sponsors & CROs Investigators Ethics Committees
3

Regulatory Standards & Data Governance

Data documentation, international privacy, and global standards

ISO ICH HL7 CDISC CDASH
4

Planning & Documentation in CDM

Preparing a Data Management Plan (DMP) — purpose, components, and compliance

Data Management Plan Study Integrity Regulatory Compliance
5

Preparing Essential Study Documents

Protocols, consent forms, IBs, CRFs, and clinical study reports

Protocols ICF Investigator Brochure CSR
6

EDC Systems & Implementation

Electronic Data Capture setup, configuration, and User Acceptance Testing (UAT)

EDC Setup UAT System Validation
7

Database & Form Design (CRF & IXRS)

Design principles for electronic/paper CRFs and IXRS interfaces

CRF Design IXRS Data Quality Impact
8

Data Collection, Entry & Tracking

Data collection methodologies, entry best practices, and error mitigation

Data Entry Tracking Mechanisms Error Mitigation
9

CRF Flow & Data Handling at Site Level

CRF lifecycle, inventory management, and discrepancy tracking

CRF Lifecycle Entry Status Monitoring Discrepancy Tracking
10

Data Quality Assurance

Validation workflows, edit checks, and verification for data accuracy

Edit Checks Validation Workflows Data Verification
11

Managing Data Discrepancies

Tools and techniques for identifying, reviewing, and resolving discrepancies

Discrepancy Resolution User Access Config Query Management
12

Database Lock Procedures

Database locking principles, soft lock vs hard lock, and unlock scenarios

Soft Lock Hard Lock Unlock Procedures
13

QA/QC & Compliance Audits

Quality assurance, audit readiness, and source data verification per GCP

QA & QC Audit Readiness SDV GCP Compliance
14

Data Archiving & Lifecycle Management

Archiving principles, retention requirements, and retrieval practices

Archival Systems Lifecycle Strategy Regulatory Retention
15

CDM & eClinical Tools

CDMS, EDC, CTMS, ePRO, and RTSM — integration for streamlined workflows

CDMS CTMS ePRO RTSM
16

Virtual & Technology-Driven Trials

eConsent, remote monitoring, IWRS, telemedicine, and AI/ML in CDM

eConsent Remote Monitoring IWRS AI & ML in CDM
17

Case Studies & Practical Scenarios

Apply your learning through real-life clinical trial examples and case analyses to reinforce practical understanding and problem-solving skills

Real-Life Trial Examples Case Analyses Problem Solving Applied Knowledge

Eligibility

Graduates in any discipline are eligible. Medical and Healthcare graduates especially welcome:

Any Graduate MBBS / BDS BAMS / BHMS Pharm D M.Pharmacy / B.Pharmacy Life Sciences

Programme Duration

6 to 12 Months

Minimum 6 months · Maximum 12 months

Programme Mode

Online Mode — Registrations Open

Programmes Available

PG Diploma · Executive Diploma · Professional Certification

Programme Fee

Professional Certification

Full Time / Part Time · Online Live Classes

₹55,000

or $598 USD

17 comprehensive CDM modules
EDC, CDMS, CTMS & eClinical tool training
CDISC, CDASH & GCP regulatory standards
Postgraduate Diploma certificate