All Cooperative Group regulatory submissions must be faxed, emailed or mailed to the CTSU Central Regulatory Office.
The CTSU Regulatory Office offers a centralized processing of regulatory documents with a real-time access to the regulatory data to the Cooperative Groups, CTSU, and CTEP.
In order to capture the necessary data to ensure regulatory compliance, the CTSU IRB Certification form is developed to collect all required information regarding the IRB approval, and support sites using the NCI CIRB.
The following data points will be captured on this form for accuracy:
- Protocol Number
- Protocol Version Date (required for amendments)
- Protocol Title
- Institution Name(s)
- NCI Institution Code
- OHRP Assurance Number
- Principal Investigator
- NCI Investigator Number
- Review Type (original, amendment, renewal)
- Approval Type (full, expedited, facilitated)
- Date of Local IRB Review
- IRB Number
- Expiration Date
The omission of any of these data points will delay the verification of site IRB approval in the RSS database and may delay the enrollment of patients from your site.
Additional forms are available for site use to document regulatory submissions:
For links to required forms, and contact information, please access the resources on the left side of this page.
- CTSU IRB Approval Transmittal Sheet
- CTSU Optional Form 1 - Withdrawal from Protocol Participation
- CTSU Acknowledgement Form (for NCI CIRB sites)
CTSU Regulatory Office
Coalition of National Cancer Cooperative Groups
1818 Market Street, Suite 1100
Philadelphia, Pennsylvania 19103