Global Compliance: Disclose Locally, Comply Globally

Francine Lane

April 18, 2017

APRIL 18, 2017

Discussions with TrialScope customers and others have confirmed that challenges with global clinical trial disclosure are prevalent across organizations, regardless of size. There are registries and disclosure requirements on every continent, except Antarctica.

Common challenges:

  • How do I know where, when, and what must be disclosed for this study?
  • How do I track and manage that study data was disclosed?
  • How do I know if my CROs and/or local affiliates are following disclosure requirements?
  • How can I be sure that I have interpreted the local disclosure requirements correctly?
  • How can I respond to questions on disclosure performance when a critical article on disclosure is published?
  • How is my disclosure performance over time?
  • How can I stay on top of changes and keep my organization informed?
  • What happens if I am wrong?

If these challenges are not surmounted, your organization faces increased risks of non-compliance including:

  • Financial penalties
  • Negative impacts on brand integrity by the publication of disclosure performance metrics by transparency advocates
  • Refusal of journals to consider publications containing study information
  • Delayed study-start if ethics approvals require study registration
  • Grant funding being denied or suspended for not meeting disclosure requirements

TrialScope’s Global Compliance solution can help you overcome these challenges. Global Compliance assesses your studies against a set of requirements for ClinicalTrials.gov and all WHO Primary Registries (with more requirements are being added regularly!).  You can proactively track which studies need to be disclosed, where and when, and then monitor that it is being done, whether it is by your disclosure group, local affiliate, or a CRO. 

Disclosure requirements are reviewed by our Global Compliance community, offering a variety of perspectives to hone the interpretation of requirements into what is commonly agreed across a broader community.  Changing requirements can be easily incorporated to provide the most up-to-date information that creates a foundation for a solid organizational understanding. Because all users have access to the same information concurrently, it minimizes duplicate efforts to track disclosure – as often happen when disclosure is managed with desktop tools such as spreadsheets.

About the author

As Vice President of Global Transparency for TrialScope, Francine is responsible for helping customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. She also serves as chair of the Drug Information Association (DIA) Clinical Trial Disclosure Community.