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Clinical Trial Data Management

The EDC Programming team plays a central role in the Clinical Data Management CDM process by designing, developing, and maintaining Electronic Data Capture EDC systems used in clinical trials. The team configures study designs, visit structures, and electronic case report forms eCRFs while ensuring robust validation rules, edit checks, and regulatory compliance. This module provides learners with a structured understanding of CDM including its definition, importance, evolution, workflows, and responsibilities, enabling them to recognize the critical role of CDM in generating accurate and compliant trial data and to understand the contributions of CDM professionals and cross functional collaborators.

FREE

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Course Overview

Course Curriculum

2 Subjects

CDM

49 Learning Materials

Induction and Workflow PPT

Workflow of Clinical Data Management

PPT

Standard Operating Procedures

SOP 1. Onboarding & Offboarding staff in CDM

PDF

SOP 2. Study Specific Training of Staff

PDF

SOP 3. Generating CDM Study Folder on Amazon Web Services

PDF

SOP 4. Preparation and approval of a Data Management plan

PDF

SOP 5. CRF Designing

PDF

SOP 6. Preparation of study specific eCRF completion guidelines

PDF

SOP 7. Data Validation Plan and User Acceptance Testing

PDF

SOP 8. Database designing, User Acceptance Testing (UAT), Database (DB)Go Live and Update

PDF

SOP 9. Site and User Access Creation

PDF

SOP 10. Discrepancy Management

PDF

SOP 11. SAE Reconciliation

PDF

SOP 12. Protocol Deviation Management

PDF

SOP 13. Analysis

PDF

SOP 14. Data transfer

PDF

SOP 15. Database Lock and Unlock

PDF

SOP 16. Clinical Data Archival and Retrieval

PDF

Introductory Video

Introductory Video

Video
00:04:20

CDM Content

PDF

Module 1 Introduction to CDM

Introduction to CDM

Video
00:37:50

Module 2 Project Management in CDM

Project Management Supporting and Application

Video
01:13:24

Module 3 Start-Up Phase

Clinical Study Protocol

Video
00:07:17

Data Management Plan

Video
00:06:44

Case Report Form

Video
00:15:54

Study Design Specification

Video
00:05:39

eCRF Designing and Screen UAT

Video
00:15:28

Data Validation Plan

Video
00:06:37

Optimizing clinical data_ A strategic approach to EDC

Video
00:12:06

eCRF Completion Guidelines

Video
00:07:08

Electronic Trial Master File

Video
00:10:42

Drafting EDTA and Third-Party Database Integration

Video
00:09:35

Medical Coding Dictionary Integration and UAT

Video
00:01:51

Test Run for Dataset

Video
00:01:28

Start-Up Quality Control

Video
00:03:30

Study Go-Live

Video
00:02:18

Module 4 Conduct Phase

Introduction to Conduct Phase and Site Onboarding

Video
00:11:16

Data cleaning

Video
00:10:59

Query Management

Video
00:07:01

Data metrices in CDM

Video
00:35:59

PD Reconciliation

Video
00:08:49

SAE data reconciliation

Video
00:10:10

MedDRA Coding

Video
00:06:45

WHO-DD Coding

Video
00:15:03

Post production changes and their impact

Video
00:06:18

Patient Reported Outcomes

Video
00:03:46

Laboratory Data

Video
00:06:08

Conduct Phase - QC Process

Video
00:03:44

Interim Analysis

Video
00:08:26

Module 5 Close-Out Phase

Close-Out Phase

Video
00:56:26

Healthcare Technology

8 Learning Materials

Introduction video

Index of Clinical suite platform

PDF

Introduction to the Clinical suite Platforms

Introduction to Electronic Data Capture

Video
00:21:41

Electronic Data Capture- eCRF Designing

eCRF Designing

Video
00:33:57

Electronic Data Capture - StakeHolder

StakeHolder in EDC

Video
00:32:04

Electronic Data Capture - Reports

EDC Reports

Video
00:22:41

Electronic Trial Master File (eTMF)

Electronic Trial Master File (eTMF)

Video
00:21:54

Image Transfer / File Manager

Image Transfer / File Manager

Video
00:11:42

AI-based PV narrative writing for pharmacovigilance

AI-based PV Narrative

Video
00:02:09

Course Instructor