Page 298 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q019
SOP Title: Non-Regulated & Non-Human Research
− Quality Specialist will perform a review of the staffing plan to ensure that all research staff members are credentialed and have completed Children’s Health required training;
− Quality Specialist will verify how the data is being collected: anonymous vs. identifiable;
− For projects where identifiable data is being collected, a Preparatory to Research Attestation statement needs to be obtained from the researcher. A Preparatory to Research attestation statement will not be required for projects where a researcher is collecting aggregate or de-identified data;
− Quality Specialist will send the CHRA Medical Director of Research a courtesy e-mail apprising him about the project;
− Quality Specialist will obtain an email response from the CHRA Medical Director confirming approval of the project.
− Quality Specialist will update the researcher about approval.
− For non-regulated projects that are deemed as “Quality Improvement” or “Quality Assurance” projects, assigned QS reviewer will also inform Children’s Health Quality and Patient Safety Department about the project. A copy of the IRB determination letter along with the application will be furnished to department contact (Emilee Gubeno, Director of Clinical Quality Improvement). A copy of the e-mail correspondence will need to be saved in the project folder.
6. REDCAP ENTRY – EXAMPLE
1. Create a profile of either the “Non-Regulated Research” or “Non-Human Research” project in CHRA REDCap.
2. For Study ID (short title), enter the type of project_PI Name_Name from Study Title. For example, “Non-Regulated_Research_McMichael_Simulation”.
3. Enter “N/A” for Velos, eIRB, and any other data points that don’t apply.
SOP No. 21, 09-03-2019, 06-09-2020, 10-07-2020; 06-03-2022