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WIRB Clinical Pharmacology Unit (CPU) for Phase I Submissions
Guidance for Phase I Action Requests to WIRB
- General CPU Information
- WIRB Site Approval for Phase I Research
- Required UW Forms
- CPU (Phase I) Initial Review Guidance for WIRB Submission
- CPU (Phase I) Consent Preparation Guidance for WIRB Submission
- CPU Initial Review Submission Process
- CPU (Phase I) Change in Research Guidance for WIRB Submission
- CPU CIR Submission Process
- CPU Site Progress Reports
- CPU Unanticipated Problems, "Promptly Reportable Information"
General CPU Information
The 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 email@example.com.
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 firstname.lastname@example.org.
WIRB Site Approval for Phase I Research
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
- Conflict of Interest (COI) Form -- Assessment form for potential conflicts of interest for research involving human subjects
- COI Form
- Shared Checklist--A checklist that is utilized by both the research team and the UW WIRB Gateway Team for guidance on institutional policies required by the UW for inclusion with all protocols.
- UW Clinical Trials Agreement (CTA) Form--The research team is required to review and certify that the consent form compensation for injury language is in line with the signed CTA. This form documents the PI's acceptance of this UW requirement.
- WIRB Consent Form Checklist--A checklist that provides verification to WIRB regarding language specific to protocol activities that should be used within study consent document(s)..
- HIPAA Authorization--UW-Madison retains purview of the HIPAA authorization. All HIPAA language must be removed from the consent form, and placed into a separate, stand-alone document.
- HIPAA Authrorization
CPU (Phase I) Initial Review Guidance for WIRB Submissions
The submission of Phase I research is similar to the process used for Phase II through IV. Please follow the posted guidance for Phase II through IV initial reviews with the following differences:
CPU (Phase I) Consent Preparation Guidance for WIRB Submissions
***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 IR Submission Process
The following outlines the process followed after the study is determined to be eligible to be sent to WIRB and use the CPU board.
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. Please follow the posted guidance for Phase II through IV change in research with the following differences:
CPU Site Progress Reports
Do NOT email email@example.com.
CPU Unanticipated Problems, "Promptly Reportable Information"
Please contact WIRB CPU Services for guidance. Promptly Reportable Information does not have to be submitted to WIRB Gateway Team.
The CPU phone numbers are 360-570-1261 or 866-956-2467.