Download the template(s) of your choice. The template documents open as Word files; save as a Word file to begin drafting your protocol. All instructions in the template are highlighted in blue.

including those who had previously developed a revised clinical trial protocol template with expanded eligibility criteria with Friends of Cancer Research and ASCO; and pharmaceutical industry ...

The Draft Guidance highlights that FDA does not consider all potential violations of good clinical practice guidelines or requirements (“GCPs”) to be protocol deviations even where the study ...

Examples of important protocol deviations provided in the guidance include the following: In general, the guidance emphasizes thoughtful clinical trial protocol design as a means to minimize ...

BOSTON--(BUSINESS WIRE)--Aura Biosciences, Inc. (NASDAQ: AURA), a clinical ... The trial has completed enrollment of the cohort that received bel-sar injection without light activation. Protocol ...