Modification of Previously Approved Study
1. A memo in Word or PDF format outlining the modifications requested and any effects of the proposed modifications on benefits, risks to human subjects, risk management, and consent processes;
2. A revised protocol with all proposed modifications and effects on benefits, risks, risk management, and consent processes highlighted;
3. A revised consent form, if applicable;
4. When new study personnel will execute the protocol, a description of their background appropriate to the work of the project. Include current CITI Training Certificates;
5. When new agencies will participate in the study, agency approvals.
***A response from the Fresno State CPHS will be sent to you approximately a week after you submit the modifications request and supporting documents.