The Clinical Data Management Conduct Process

In this course, we will examine the most common data collection technologies, and highlight essential definitions and concepts related to data collection and handling. We will explore various methods to ensure the required data quality, address key requirements for system validation and documentation, and conclude with data consolidation and preparation for analysis, while also reviewing the typical timelines for the conduct stage.

First, we will examine the commonly used data collection technologies, including their key characteristics, users, and data transfer channels. We will establish the fundamental concept of source data and discuss the associated regulatory requirements.

Next, we will focus on data cleaning, which involves ensuring data quality. Before we delve into the various cleaning methodologies, we will define data quality in the context of clinical trials. Fianally, will focus on the process of consolidating data from different sources and systems into a standardised database that is suitable for analysis. We will wrap up with a discussion of typical timelines and turnaround times for conducting these activities.