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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 11. STUDY CLOSEOUT/DB LOCK 11.2 – Database Lock

11.2 – Database Lock

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