Clinical Trial Disclosure Tutorial 2: Is Your Protocol Ready to be Published on a Public Registry

Despite many years of publicly registering trials based on protocol information, many companies have not modified how they write protocols to make study registration as efficient, accurate and traceable as possible.  Now there is considerable pressure to require public access to protocols, new guidance on writing protocols SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), and new requirements from the EU Pharmacovigilance regulations for observational PASS protocols.  Are you ready?  This tutorial will give you knowledge and tools to get ready, including a case study from a company that has committed to post protocols on a public portal.

Medical Writers; Heads of clinical trial disclosure groups; Clinical Research; Clinical Operations; Regulatory

Level:  Advanced

At the conclusion of this tutorial, participants will:

• Discuss clinical trial disclosure trends that point to the need to prepare protocols for public registration
• List tips in protocol writing that facilitate efficient and traceable study registration
• Summarize the proposal from SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and the requirements from the new EU PV regulations for observational PASS protocols.