Protocol Builder is a cloud-based protocol writing technology that makes it faster and easier to develop investigator-initiated clinical research protocols that meet IRB and regulatory standards. Recently enhanced with the following features based on user feedback, Protocol Builder continues to raise the bar for protocol development. Please see below to learn more about this robust tool that provides hospitals and medical schools IRB and clinical research support services.
Updated NIH IND/IDE Template. Now updated to this template in accordance with recent changes to the template offered by the NIH and FDA. It follows the standards outlined in the ICH Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6).
More Efficient Review Process. After you make changes to a protocol, you can select individuals to notify about the updates. They will receive an email and see a “Needs Review” alert in Protocol Builder that links to a list of all changes.
Research Administrator Role. You can now add research administrators to the Personnel section in the Cover Page of a protocol. This allows them to review the protocol using Protocol Builder. Their names will not appear in the document output.