FDA's HSP/BIMO Progress Report

The FDA has released a progress report on its Human Subjects Protection/Bioresearch Monitoring Initiative (HSP/BIMO).  In the 18 months since launch several new regulations and guidelines have been produced, including:

• IRB registration;
• Expanded access to investigational drugs;
• A new informed consent essential element notifying subjects of study registry on the clinicaltrials.gov system;
• The final guidance on 1572s;
• New guidance on investigator responsibilities;

And a whole bunch more.  Included in the report is an update from the FDA/Duke University Clinical Trials Transformation Initiative (CTTI), which includes among many other things a joint initiative between FDA and EMA for good clinical practice.  The EMA/FDA GCP terms of engagement and procedures document is here.  The HSP/BIMO report is here.