WIRB Clinical Pharmacology Unit (CPU) for Phase I Submissions
General CPU InformationThe Western IRB has a dedicated CPU Board that services Phase I research protocols independently from their Phase II through IV protocols. The CPU Board has a separate support office devoted specifically to Phase I research (CPU Services) which does not utilize the Client Services Desk or our traditional points of contact. If study teams need to communicate with the CPU for Phase 1 studies, the email contact is Phase1@wirb.com instead of firstname.lastname@example.org. The main CPU phone number is 866-956-2467. The main point of contact assigned to the UW for all Phase 1 studies is Natalie Turner. She can be reached at 360-570-1261 or email@example.com.
CPU (Phase I) Initial Review Guidance for WIRB SubmissionsThe submission of Phase I research is similar to the process used for Phase II through IV. Please follow the posted guidance (e.g., eligibility, required forms) for Phase II through IV initial reviews with the following differences:
- WIRB Site Approval
- The University of Wisconsin-Madison (UW) and Clinical Research Unit (CRU) have undergone the required WIRB site approval.
- CPU Services will not accept research that involves Legally Authorized Representatives (LARs) or children.
- Consent Preparation
- The CPU will NOT edit your submitted consent document(s). These documents must have all UW required language components added upon submission.
- Use the CPU Services Subject Consent Form template ONLY. Two distinct templates for Phase I studies exist: one for oncology studies and a second that encompasses all other Phase I research.
- Incorporate the sponsor's Subject Consent Form into the UW/WIRB Subject Consent form template, tracking the changes.
- Prepare corresponding clean copies for each consent form(s) for CPU Phase I review.
CPU (Phase I) Changes, Site Progress Reports, and Unanticipated Problems Guidance for WIRB Submissions
- CPU (Phase I) Change in Research Guidance for WIRB Submissions
- The submission of changes for Phase I research is similar to Phase II through IV.
- CPU Site Progress Reports
- Do NOT email firstname.lastname@example.org.
- CPU Unanticipated Problems, "Promptly Reportable Information"
- Please contact WIRB CPU Services for guidance. Promptly Reportable Information does not have to be submitted to the Reliance Team.
- The CPU phone numbers are 360-570-1261 or 866-956-2467.