What happens if the RDRC requires changes or more information?
Once the protocol has been reviewed, the RDRC’s comments are emailed to the Principal Investigator (PI) or their research coordinator by EHRS staff. When the comments have been satisfactorily addressed, a letter recommending approval will be sent by EHRS to the IRB with a copy to the PI. Any changes made to the protocol or consent form must be sent to the IRB by the PI. The Chairman of the RDRC will sign approval letters for 21 CFR 361.1 research protocols and the Radiation Safety Officer (RSO) will sign all other approval letters.
