Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs

Chapter 13

Clinical Data Coordination

Cheryl Kious

13.1 Introduction

The goal of clinical research trials is to generate data that proves the safety and effectiveness of a drug or device, leading to marketing approval by a regulatory authority. The acquisition, validation, and integration of this clinical data, known as clinical data management (CDM), are an integral component of the drug development process. CDM is the process of preparing the clinical data for statistical analysis; the conclusions from this analysis form the basis of a regulatory submission for approval and subsequent marketing. The discipline of CDM includes case report form design, clinical study database design and programming, data entry, data validation, coding, quality control, database finalization, and data archiving. CDM begins in the study design phase and ends when the clinical database is finalized and the data are considered ready for statistical analysis. CDM processes are greatly enhanced through the development of a comprehensive data management plan, adherence to good CDM practices, and by ensuring that quality steps are built into all stages of data handling.

CDM is a comprehensive series of activities performed by a diverse team of people, ranging from data entry operators, database programmers, and clinical data coordinators to coding specialists. The core of the CDM team is the lead data manager (LDM), who serves as the lead clinical data coordinator and primary CDM contact for a clinical ...