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Apr 6, 2017

4 Rules for Building an eClinical Qualification Framework


by Rob Sims


UL Compliance To Performance


Marketing Programs Manager


As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and post marketing studies. 

In this clinical ecosystem is also site personnel qualification technology, which must be targeted to each role within the clinical research site. Otherwise, individuals within the site would receive too much or not the right protocol and non-protocol items that align with their role.

There are four guiding rules for structuring this Clinical Site Qualification application within a company’s clinical system architecture, so that it improves the role-based performance of clinical site personnel, improves the acumen and performance of investigators and accelerates ramp-up time for new sites.

When this technology is seamlessly integrated with a clinical management system, sponsors can realize 40 percent or greater reduction in site initiation costs.  At the same time, site personnel can demonstrate improved proficiency within studies.

And there’s also the benefit of accelerated study start-up. Inadequate knowledge among clinical investigators and support staff, investigational review boards, and corporate compliance personnel can delay clinical studies and postpone product approval by regulators. 



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Based on Underwriter Laboratory’s (UL) experience with training platforms, the following four rules for building an eClinical qualification framework are recommended:  
  • Ensuring training compliance requires accurate, timely distribution of protocols, Good Clinical Practices (GCP) content and other areas (such as use of Electronic Data Capture applications) to all responsible parties, and consistent naming conventions ensure the administrator has the ability to easily locate the right document for reporting and modification reasons. The eClinical Learning Management System (LMS) should organize each study by geography, sponsor, product, and role (PI, CRA, CRC, etc.)
  • Build a Training Hierarchy that Accommodates Growth: In many cases, the system is expected to grow as the contract research organization  gains additional sponsors and manages trials around the world. It is critical that each investigator and clinical research associate within each study, and in each location, receive just the training that matters to their role. 
  • Develop a Process for Maintaining Site Personnel Data: To organize site personnel and align them into defined training requirements, the clinical management team must define and maintain meaningful user data attributes. This can be accomplished via manual or automated means. Data integrity and the ability to view real-time information is critical. Common “user” attributes, such as name, e-mail, and organization, can be fed from the CTMS. In addition, the eClinical qualification solution must use four clinical site personnel “attributes”: study, site, role and region, to provide segmented visibility to the sponsor’s site managers.
  • Provide Segmented Management Visibility: The delivery and tracking of qualifications must be segmented, so that study managers can only view site personnel progress for just that single study. Ideally, a “qualification check” should be displayed in the CTMS or wherever site personnel records are stored.




By applying these rules, study teams can achieve the following goals: 
  • Provide timely and consistent updates of critical study information to project teams as well as external study teams.
  • Gain assurances that the study and product information was received and understood by the responsible person. 
  • Start or complete post-marketing commitments on time.
It's clear that technology will continue to affect global clinical trials.  Pharmaceutical companies and CROs will find it advantageous to strategically apply technology to improve all facets of training and to manage the associated data. Following these four rules should enable study teams to engage employees in more effective clinical trial management.



Robert Sims develops marketing campaigns,  prepares market research, and drives thought leadership for UL Compliance to Performance. Prior to this current role, Rob delivered Client Communications services, in which he developed more than 80 enterprise learning and development rollout programs for new UL clients. Rob has an extensive technical documentation and marketing communications background that spans the fields of IT, regulated industry and life sciences. He has held communication-related roles at leading companies that include Merrill Lynch, Dow Jones, EDS, and BIOSIS. Rob holds a BA in Journalism from Pennsylvania State University and a Master’s                                       degree in Professional Communication from LaSalle University.

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