Pre-Submission Form - New!
April 08, 2024
Beginning April 29, 2024, a new Pre-Submission Form will be added to iRIS to facilitate earlier contract and clinical research finance review for new clinical trials.
The Pre-Submission Form must be completed prior to formal submission of the New Project Application (NPA) to initiate SRC and IRB review. Please read below for additional guidance on this new process, including an informational Office Hours webinar available to all DF/HCC research staff.
What is the new Pre-Submission Form process?
• For any new DF/HCC study that requires a Clinical Trial Agreement (CTA), the research team will first complete and submit the Pre-Submission Form in iRIS prior to submission of the full packet and NPA.
What is the purpose of this new form?
• This new form allows budget and contract review and negotiations to begin earlier, with the goal of expediting the activation of new trials once IRB approved.
How is the form completed?
• Study teams will complete the Pre-Submission Form within iRIS and attach the applicable documents to facilitate review (e.g., CTA, draft protocol document).
• Importantly, this process does not replace any part of the formal NPA submission. However, it will create an initial record for the study in iRIS that the team will then access to submit the full NPA when ready.
When does this new process take effect?
• The new form will be live as of Monday, April 29, 2024. We encourage all research teams to identify upcoming new studies with planned NPA submission after April 29, and begin to prepare associated documents.
Questions?
• Review: Overview and FAQ: Pre-Submission Form for New Clinical Trials
• Attend the upcoming iRIS Office Hours session on Monday, April 22 at 3:00pm. We will provide a detailed overview and demo of the new Pre-Submission Form process in iRIS.
Zoom link; Passcode: iRIS