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Introduction to Clinical Data management

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Week 1

1.0 – CLINICAL TRIAL RESEARCH OVERVIEW 5 Topics

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1.1 – Drug discovery and Clinical Research?

Clinical Trial Phases

1.3 – Clinical Study Team

1.4 – Industry Regulations Empty

1.5 – Sponsor vs Clinical Research Organization

WEEK 2

2.0 CLINICAL DATA MANAGEMENT OVERVIEW 3 Topics

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2.1 – What is Clinical Data Management

2.2 – Phases of CDM Activities

2.3 – CDM Regulations, Guidelines, and Standards

WEEK 3

3.0 – STUDY START- UP (Part I) 4 Topics

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3.1 – CDM Start-up Overview

3.2 – Clinical Study Protocol

3.3 – Clinical Data Management Systems

3.4 – eCRF Specifications

WEEK 4

4.0 – STUDY START- UP (Part II) 3 Topics

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4.1 – Database Build

4.2 – eCRF Review/Screen UAT

4.3 – System Integrations

WEEK 5

5.0 – STUDY START- UP (Part III) 3 Topics

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5.1 – Data Validation Plan

5.2 – Edit Check Programming

5.3 – Universal Acceptance Testing (UAT)

WEEK 6

6.0 – STUDY START- UP (Part IV) 1 Topic

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6.1 – Universal Acceptance Testing (UAT)

WEEK 7

7.0 – STUDY START-UP (Part V) 3 Topics

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7.1 – eCRF Completion Guidelines

7.2 – Data Management Plan

7.3 – Non-CRF data (Vendor data)

WEEK 8

8.0 – STUDY START-UP (Part VI) 5 Topics

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8.1 – Serious Adverse Event (SAE) plan

8.2 – Medical Coding

8.3 – Data Review Plan

8.4 – eTMF Plan

8.5 – Protocol Deviation Plan

Week 9

9.0 – STUDY CONDUCT 9 Topics

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9.1 – Study Conduct overview

9.2 – Data Entry

9.3 – Data Review

9.4 External Data Reconciliation

9.5 – Snapshots

9.6 – Status Reports and Metrics

9.7 – SAE Reconciliation

9.8 – EDC User Access reconciliation

9.9 – Medical Coding Review

WEEK 10

10 – STUDY CONDUCT (Part II) 1 Topic

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10.1 – Discrepancy Management

Week 11

11. STUDY CLOSEOUT/DB LOCK 5 Topics

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11.1 – CDM Closeout Overview

11.2 – Database Lock

11.3 – Final Patient Activities

11.4 – Post Lock Activities

11.5 – Decommissioning Study URL

Week 12

12 – NEXT STEPS

Participants 10

Introduction to Clinical Data management 1.0 – CLINICAL TRIAL RESEARCH OVERVIEW

1.0 – CLINICAL TRIAL RESEARCH OVERVIEW

CDMADM 7 Courses

Clinical data management (CDM) is a critical component of clinical research and trials, ensuring that data collected during these studies is accurate, reliable, and compliant with regulatory standards. It involves the collection, cleaning, validation, and management of clinical trial data to support the generation of high-quality evidence for evaluating the safety and efficacy of medical treatments and interventions.

Lesson Content

0% Complete 0/5 Steps

1.1 – Drug discovery and Clinical Research?

Clinical Trial Phases

1.3 – Clinical Study Team

1.4 – Industry Regulations Empty

1.5 – Sponsor vs Clinical Research Organization

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