This course will cover the key global clinical trial disclosure and transparency requirements and background information on how the requirements have evolved from 2004-2019.  The course will also provide an underpinning of the policies and regulations in order to give participants a firm foundation and tools in which to successfully work in this space. This course will cover the key global clinical trial disclosure and transparency requirements and background information on how the requirements have evolved from 2004-2019.  The course will also provide an underpinning of the policies and regulations in order to give participants a firm foundation and tools in which to successfully work in this space. 
The topics to be covered are:

• The evolution from ICMJE requirements in 2004 to today’s requirements for sharing of clinical study documents/data in relation to regulatory submissions, and sharing of data for secondary use
• The outside influencers and internal stakeholders – who are they? As disclosure responsible when and what topics do you need to consider/discuss internally in your organization.
• A deeper dig into the EU and US requirements, similarities and differences
• Highlights of the FDA Amendments Act Final Rule expanding reporting requirements in ClinicalTrials.gov
• The global environment of local and primary WHO registers 

Learning Objectives

• At the conclusion of this short course, attendees will be able to:
• Explain the evolution of transparency requirements
• Identify influencers and internal stakeholders
• Recognize the differences between EU and US requirements

Target Audience

• Professionals from industry and academia relatively new to the disclosure and transparency area or who want to have a refresher on the policies and regulations underpinning the disclosure/transparency landscape.
• Professionals working with:
  • Disclosure, Trial and Results Registration Activities
  • Clinical Operationso Publication Planning
  • Medical Writing
  • Regulatory Submissions
  • Biostatistics
  • Compliance

Workshop Outline: