WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

Risk-Based Approaches - Best practices for ensuring clinical data quality

  • 10 September 2013
  • Author: Webmaster1
  • Number of views: 1511
  • 0 Comments
Risk-Based Approaches - Best practices for ensuring clinical data quality

Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials.  The reasons, while diverse, include fear based on perception and interpretation of regulatory requirements. These processes have played a very large role in the high costs associated with clinical trials, without delivering commensurate value.  Reasons are many, but surely include propagation of practices established during the years that trials relied on paper-based case report forms (CRFs) without considering optimization of the processes to take advantage of the technology provided by electronic data capture (EDC).  All of this has resulted in the institutionalization of high cost, unproven value, manpower-intensive practices that do little to serve the interests of subject safety or quality data.  Pharmaceutical, biotech, and medical device industries experiencing unprecedented economic upheaval can no longer justify practices that deliver little value at exorbitant cost. Rather than continuing to spend time, energy, and money focusing on minutiae, e.g., the ability of site personnel to properly transcribe observations from one medium to another, those engaged in clinical trial conduct must re-focus their energies on  the aspects of the clinical trial that matter most, such as protocol compliance, subject safety, data timeliness, and data integrity.  Through the use of more up-to-date methodologies and technologies, companies can effectively address these concerns while saving both time and money. This paper addresses the regulatory and business rationales for adopting monitoring-related tools and processes that, if implemented thoughtfully, should deliver higher-quality trial data, faster, and at significantly lower cost.

Documents to download

Print
Tags:
Rate this article:
No rating

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«July 2025»
MonTueWedThuFriSatSun
30
Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

の日本語版2025.2JP1が2025年6月30日にリリースされました。

Read more
123456
78910111213
14151617181920
21222324252627
28293031123
45678910

Upcoming events Events RSSiCalendar export