When submitting an IRB approval of a protocol amendment to the CTSU Central Regulatory Office the "NCI version date" must be included on the CTSU IRB Certification form.

The CTSU Central Regulatory Office processes protocol amendment approval documents within 3 business days after receipt at CTSU. If the paperwork is incomplete, the CTSU notifies the site that additional information is needed. A copy of the materials is retained in the site's Regulatory Binder.

Sites requesting the status of the registration should access the RSS Site Registration Status page on the CTSU Registered Member Web Site or contact the CTSU Help Desk at 1 (888) 823 5923 after 3 business days. Sites requiring processing for time of need enrollments should contact the CTSU Help Desk for assistance with submission of the regulatory packet.

Once the IRB has approved the amendment and revised consent, the Investigator destroys all unsigned copies of the old consent, retaining one copy in the Regulatory Binder. One copy of the old protocol is also retained in the Regulatory Binder. The sponsoring Cooperative Group will direct whether patients currently receiving treatment must review and sign the new consent form. Versions of the consent previously signed by the patient must be retained in the patient's protocol file.