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2018 Abstracts to the Programme

Title: Handling the increasing volume and complexity of external data in Clinical Trials in Data Management

Presenter: O’DONNELL, Rhona: ICON

Presentation Slides: Click here to access

Organisation: ICON


The number of sources of external data is increasing year on year due to the increasing complexity of clinical trial protocols. This presents some challenges to Data Management in handling the large volumes of data and the requirement to reconcile multiple data sources in a timely manner for sites.

ICON has worked on some standard processes to optimise the management of external data sources – this covers:

  • A source data handling set-up and maintenance process
  • Integrating external data into EDC where it makes sense to do so
  • Defining a standard reconciliation mapping and process for each major external data type
  • Setting a standard process for big data volumes e.g. actigraphy data
  • Implementation of a Data Review Tool using Spotfire
  • Using the standard mapping process to realise efficiencies in data aggregation before data transform and transfer

ICON would like to present its learnings from implementing these processes to provide some useful insights and lessons learned from managing external data for Data Management.

Learning Objective 1: Share ICON’s experience of setting up a Source Data Handling Process

Learning Objective 2: Share ICON’s experience using a standard Data Reconciliation mapping process with major efficiencies gained

Learning Objective 3: Share ICON’s lessons learned and efficiencies gained for External Data Handling for large volumes for Data Management


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