Page 186 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q010
SOP Title: Performance Site Approval Process For External IRB-Approved Research Projects
4.2 Projects that require assistance from ancillary departments (e.g. IDS pharmacy, Laboratory/Pathology, Radiology, Infusion Department, etc.) will need members of that supporting department to 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.
4.2a. 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 the following needs to be provided for review: the PI’s name, Velos #, STU #, along with a copy of the Protocol.
4.2b. 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)
4.2c. Standard Review – Clinical projects that utilize technologies provided by the study sponsor on loan and connect to Children’s network for the transmission of data to the sponsor or third party will need to have a Standard Review assessment. Other qualifying scenarios include the following: (1) any software which the sponsor directs the local researcher to download on a Children’s issued computer (desktop/laptop/portable device); (2) Any medical device (investigational or FDA approved) that is not being used in the Children’s environment.
4.2d. Advanced Analytics (AA) services – AA provides researchers with EPIC reports and other data requests following site approval. The submission process is outlined in SOP# 23 Data Requests. After submission, typically a member of the AA team will work with the Requestor / PI of the project to determine the exact nature of the request and the time commitment needed to provide reports, etc.
4.2e. Other Departments – Clinical projects that provide services to support the study protocol will be contacted for reviewand approval.
4.3 For projects releasing data / specimens outside CMC, QS will direct members of the research team to inquire with CHRA by emailing Children’s Health Research Contracts at ResearchContracts@childrens.com for DUA or MTA determination.
5. SPECIFIC PROCEDURE
5.1 Scope PSA Review Process
Timeline of Children’s Performance Site Review
• CHRA receives notification from 1) Research Administration Director, 2) Research Administration Senior Director, or 3) Researcher directly requesting research activities on Children’s Health campus.
SOP No. 9: 12-20-2018; 02-17-2021; 08-25-2021;