RTOG 1306, ACTION LETTER and Amendment 3: 8/27/2014

NRG Oncology has received an Action Letter for crizotinib

Accrual of new patients must be suspended until the IRB of record has reviewed and approved a CTEP-approved amendment created in response to this Action Letter. This amendment can undergo expedited approval at the discretion of the IRB Chair/designee as explained on the first page of the Action Letter.

Patients currently on study may continue on study provided they are informed of the new and/or modified risk information. This information should be communicated to patients already enrolled on study without waiting for IRB review/approval since this information represents a significant new finding(s) that developed during the course of the research that may relate to a patient’s willingness to continue participation and per the Office for Human Research Protections, the regulations do not require IRB review and approval of statements describing such significant new findings before they are provided to already enrolled patients. Documentation of their informed consent should be carried out according to local IRB requirements.