Page 291 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q018
SOP Title: Assessing & Requesting Ancillary Service Support
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the steps to be followed for research projects requiring assistance from ancillary service departments.
2. INTRODUCTION
For research projects needing ancillary service support, RA at Children’s Health requires members of the research team to reach out to the department(s) lending support in order to apprise them in a timely manner regarding the type(s) of assistance that will be required to support the project.
3. SCOPE
This SOP applies to all researchers conducting research at Children’s Health.
4. RESPONSIBILITIES
4.1 Children’s Quality Specialist
The QS will work with the research team at the time of initial IRB application submission to inform them of Children’s RA SOP with regards to ancillary service support.
5. SPECIFIC PROCEDURE
Members of ancillary service departments (e.g. IDS pharmacy, Laboratory/Pathology, DA/DI, IDS, etc.) will review the study protocol, identify support services, and grant approval prior to PSA being issued. Some departments will provide a support letter including identification of services that are required to support the study.
1. At the time of initial IRB review, an assigned member of QS team will review the IRB submission and identify departments that will need to be informed about the project. Depending on the nature of the study, the following ancillary services department may need to be involved in the review of the project:
a. Laboratory & Pathology Services – Studies that require assistance from Laboratory and Pathology Services will need to have a Research Laboratory Support Letter on file. Researchers will be directed to LabResearchAdmin@Childrens.com and provide the following: the PI’s name, Velos #, STU #, along with a copy of the Protocol.
b. Investigational Drug Services – Clinical projects that utilize investigational drugs will need to have their protocol reviewed by IDS prior to initiation of the study. Researchers will be directed to IDSRx@Childrens.com and the following needs to be provided: the PI’s name, Velos #, STU #, along with a copy of the Protocol/pharmacy manual (if available)
c. Standard Review – Clinical projects that utilize technologies provided by the study sponsor on loan and connect to Children’s network for the
SOP No. 17, 12-21-2018; 04-03-2020; 02-17-2021; 08-19-2021; 06-03-22