Copernicus Group IRB > Fee Schedule

FEE SCHEDULE

CGIRB offers special fee considerations for the following:

Phase IV and Registry Studies
Large Multi-site Studies (based on number of sites and the nature of the study)
Social-Behavioral Studies
Choosing CGIRB as the IRB of Record for Complete Development Programs Phase II-IV (first time use in humans through pivotal trials)

Please contact us regarding specific details.

STANDARD FEES:

INITIAL REVIEW
Initial Protocol Review	$1000
Review of each Principal Investigator (PI)	$600
Pre-Review of a Protocol	$850

MODIFICATIONS AFTER INITIAL REVIEW
Protocol Amendment (no revision to the Subject Information & Consent Form)	$200 per PI
Protocol Amendment (revision to the Subject Information and Consent Form)	$300 per PI
Review of New or Revised Advertisement *Plus a $50 administrative fee per PI requiring approval for each ad or series of ads	$100 per ad*
Review of HIPAA Waiver	$50 per PI
Revised Subject Information and Consent Form	$200 per PI
Continuing Review of a Protocol	$800
Continuing Review of a PI	$500 per PI
Request for Site Specific Acknowledgement	$50 per item
Revised Clinical Investigator Brochure Review/Acknowledgement	NO CHARGE
IND Safety Report Review/Acknowledgement	NO CHARGE
Study Closeout	NO CHARGE


ADDITIONAL SERVICES AND CONSIDERATIONS
Certified Translation Services	Cost + 15% admin fee ($500 maximum)
Duplication Requests (replacement charge)	$25 per document
Site Visits: ie, Board Requested, for Cause or Massachusetts	Cost + 15% admin fee
Teleconferences/Videoconferences/Investigator Meetings	Hourly rate + travel expense
Training & Consulting	Billed on an individual basis

Copernicus Group IRB invoices are issued Net 30 Day. Please be aware that finance charges may be assessed at an annual rate of 12% from the due date of an invoice.


Print Date: May 11, 2008