White Papers

The Evolution of Clinical Data Management to Clinical Data Science

Part 1: Drivers

A Reflection Paper on the impact of the Clinical Research industry trends on Clinical Data Management
Date Published: June 4, 2019

The main objective of this paper is to provide a forward‐looking and pragmatic view on why and how emerging study designs, regulations and technology innovations are reshaping the role and profile of CDM.

Part 2: The technology enablers

A Reflection Paper on how technology will enable the evolution of Clinical Data Management to Clinical Data Science
Date Published: March  5, 2020

This second paper focuses on the technologies enabling our evolution towards Clinical Data Science and allowing us to efficiently manage the 5Vs of clinical data (i.e., Variety, Volume, Velocity, Veracity and Value). It shares insights and lessons learned from leaders, pioneers and early adopters of those emerging technologies.

Part 3: The evolution of the CDM role

A Reflection Paper on the evolution of CDM skillsets and competencies
Date Published: August 31, 2020

This paper provide insights on how CDM professionals who have successfully and passionately contributed to the credibility of CDM can evolve their skillsets and competencies to cope with the increasing complexities of clinical research which demands novel approaches maximizing the potential of available technologies.

Interactive Reflection Papers Now Available

Data Integrity

Audit Trail Review

An Industry Position Paper on the use of Audit Trail Review (ATR) as a key tool to ensure data integrity
Date Published: October 01, 2020 (Editorial update: October 10, 2020)
Note: The eClinical Forum Steering Committee review is in progress.

This paper from the eClinical Forum and SCDM outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large audit trail datasets. It provides recommendations on risk-based use cases for ATR and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

eSource

eSource in Clinical Research

A Data Management Perspective on the Use of Mobile Health Technology
Date Published: September 30, 2016

Electronic source data (eSource) in the form of mHealth technologies used for study participant data collection is gaining momentum within the clinical research setting. To effectively adopt mHealth technologies as new data sources, we propose a principles-based approach to the evaluation of eSource, as outlined in the following key areas: technology, people, processes,
and standards.

eSource Implementation in Clinical Research

A Data Management Perspective
Date Published: June 12, 2014

Electronic technologies have redefined industries such as banking and commerce. Similarly, advances in technology are bringing massive changes to the healthcare realm, nearing a tipping point for overhauling every aspect of healthcare delivery and records management.

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