Investigator Manual
Where is the investigator manual on the new website?
The investigator manual that was posted on the older version of our website still exists on this new version of our website, but in a different format. All the content has been moved to separate pages on our website, grouped by topics. For example, the content that was in the investigator manual regarding FDA regulated research is now broken up into several information pages that are under a main page called “FDA Regulated Research”. The previous information from the manual is there: Research with FDA Regulated Drugs or Biologics, Research with FDA Regulated Devices, and Expanded Access. We have also added new content to this topic which was not previously in the investigator manual: Single Patient Expanded Access, IND Safety Reports, and Research involving Artificial Intelligence.
You can search for any topic with just one word in the search bar that is in the top right-hand corner of each web page. For example, if you type in “FDA” in the search bar, many pages show up where you can access information about FDA regulated research.
We understand that our content is now in a new format on our website, and we hope that you find the robust search feature and additional new content to be useful.