Practical Guide to Clinical Data Management

The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then,

chapter 1 | 6 pages

The Data Management Plan

chapter 2 | 14 pages

CRF Design Considerations

chapter 3 | 14 pages

Database Design Considerations

chapter 4 | 6 pages

Edit Checks

chapter 5 | 12 pages

Preparing to Receive Data

chapter 6 | 10 pages

Receiving Data on Paper

chapter 7 | 8 pages

Overseeing Data Collection

chapter 8 | 14 pages

Cleaning Data

chapter 9 | 10 pages

Managing Lab Data

chapter 10 | 6 pages

Non-CRF Data

chapter 11 | 10 pages

Collecting Adverse Event Data

chapter 12 | 10 pages

Creating Reports and Transferring Data

chapter 13 | 10 pages

Study Database Lock

chapter 14 | 6 pages

After Database Lock

chapter 15 | 10 pages

Standard Operating Procedures (SOPs)

chapter 16 | 6 pages

Training

chapter 17 | 6 pages

Controlling Access and Security

chapter 18 | 10 pages

Working with CROs

chapter 19 | 4 pages

Clinical Data Management Systems

chapter 20 | 8 pages

EDC Systems

chapter 21 | 8 pages

Choosing Vendor Products

chapter 22 | 8 pages

Implementing New Systems

chapter 23 | 8 pages

System Validation

chapter 24 | 6 pages

Test Procedures

chapter 25 | 6 pages

Change Control

chapter 26 | 10 pages

Coding Dictionaries and Systems

chapter 27 | 6 pages

Migrating and Archiving Data

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