For ease and accuracy of serious adverse event (SAE) reporting for investigator-initiated trials (IITs), CTTO-Regulatory is introducing additional IIT SAE report forms.  These forms are variants of the current form, but allow attribution to multiple agents within a single form. The two new PDFs forms below are available on the Coordinator Corner under the Forms tab in addition to the initial form of one agent:

• SAE Reporting Form – Apr 2019
• SAE CRF for two agents – May 2020
• SAE CRF for three or four agents – May 2020