Study Management Fee
Please refer to the Office of Sponsored Programs web page regarding the Study Management Fee. This page also contains frequently asked questions.
Fee Payment
Investigators should inform potential sponsors of this fee during contract negotiations. UAB has provided the attached memorandum to explain the Study Management Fee for industry-initiated and sponsored protocols.
For questions about the Study Management Fee, please contact Mark Marchant, Director of the Clinical Trials Administrative Office at
For information about WCG IRB fees, which are charged by WCG IRB separately from the fees charged by UAB, please contact Ms. Vanessa Champigny, Assistant Director and WCG IRB Liaison, Office of the IRB at
Forms on UAB Web Site
When WCG IRB updates its fee schedule for all items reviewed by WCG IRB, investigators should be notified by WCG IRB, alerting them to the change. If you would like a copy of the current WCG IRB Fee Schedule, please call the Office of the IRB (OIRB) at 975-3923 or email
WCG IRB Copernicus Group (WCG) has combined its five IRBs into a single IRB called “WCG IRB.” This includes Western IRB, Copernicus Group IRB, Aspire IRB, New England IRB, and Midlands IRB. All new studies are managed under WCG IRB’s OHRP/FDA IRB registration number (IRB00000533), which was previously the registration number for Western IRB.
If you do not already have a WCG IRB Connexus account, please request one immediately on the WCG IRB website (https://www.wcgirb.com/). Anyone who needs access to the submission documents must have a WCG IRB Connexus account.
Procedure for new submissions
1. The principal investigator (PI) or the PI's contact person submits the following required and other applicable documents in IRAP.
Documents required for all submissions
- Completed Institution Review Form Relying on Outside IRB
- Protocol Oversight Review Form or CTRC Approval if protocol is cancer related
- WCG Consent Language Checklist with a statement/instructions on how to complete/attach
- Sponsor’s Consent Form Template (or WCG IRB approved stamped template, if available)
- Sponsor’s Protocol
Documents required as applicable
- Release of Drugs for Human Research Use (if any drugs will be used in the protocol)
- Radiation Safety Approval
- Infection Control Approval
- Release of Pathologic Materials
- FDA Form 1572
2. A member of the OIRB staff reviews and verifies the submission materials, and then forwards the stamped Institution Review form (along with any required attachments) to the PI and the PI's contact.
3. The PI or PI's contact uploads their documents via WCG IRB Connexus, including the stamped Institution Review Form.
The UAB OIRB is notified when WCG IRB receives the submission.
Procedure for Other Reviews and Correspondence
Personnel Changes
Submit an updated Responsible Personnel List (RPL) to the Office for Sponsored Programs (OSP) via email and copy (“cc”) the UAB IRB e-mail address,
Unanticipated Problems
When WCG IRB has made a determination of an unanticipated problem, the UAB research staff notifies the UAB OIRB via email to
Monitoring Reports
The PI or contact still must submit any monitoring reports documenting deficiencies to the UAB IRB via Revision Amendment submission in IRAP.
Questions
For WCG IRB Connexus help, see the Connexus User Guide, under Forms & Guides, at the WCG IRB Connexus site: www.wcgirb.com
If you have questions regarding any of this information, please contact
- WCG IRB Liaison: Christie K Wilson, UAB IRB Protocol Analyst II,
This email address is being protected from spambots. You need JavaScript enabled to view it. ; (205) 975-3978 - Vanessa M Champigny, MBA, CIP, UAB IRB Assistant Director,
This email address is being protected from spambots. You need JavaScript enabled to view it. "
WIRB Copernicus Group (WCG) (https://www.wcgirb.com/) reviews most industry-sponsored protocols at UAB that require review by a convened IRB.
WCG IRB does not review Industry-sponsored protocols that qualify for expedited review or those that require convened review but also involve gene therapy. See the page on "Fees Charged" for more information.
Assistant Director, UAB IRB, WCG IRB Liaison
701 20th Street South
Birmingham, Alabama 35294-0104
Phone: (205) 975-3923; Fax: (205) 934-1301