Page 174 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-101
SOP Title: Clinical Research Essential Resource (CRER) Binder
Note To File
Study Title:
IRB #:
Site #:
Principal Investigator: Date:
RE: LABORATORY PERSONNEL
This Note to File (NTF) serves as official communication regarding Children's practice as it
pertains to lab personnel.
The following laboratory regulatory documents and certificates can be found in a physical binder as well as the Research e-binder:
• International Air Transport Association (IATA)
• College of American Pathologists (CAP)
• Clinical Laboratory Improvement Amendments (CLIA)
• CVs
The e-binder can be found on the shared drive using the following link:
Information for the Lab SOP can be found in Section 1, beginning from R037, in the Clinical Research Navigator e-book on the department ChildNet website using the following link: http://online.flipbuilder.com/fshn/vlpi/#p=136
Calibration records and inspection reports for all relevant laboratory equipment will be made available upon request. Additionally, temperature monitor reports are archived and can be made available upon request.
To contact lab personnel, send all correspondence to the following: E. Matthew Quintero, PhD, MSCR, MS
Department of Pathology and Laboratory Services Elias.Quinero@Childrens.com
Office phone number: (214)-456-6146 Fax number: (214)-456-0779
Signature: Date:
file://childrens.med/depts/RESEARCH/SHARE/CCS_RESEARCH/2020%20RESESARCH
%20CREDENTIALS/
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