Page 249 - eBook Version 8 Book 1 of 2 JUL 2022
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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-108 SOP Title: Lab Ordering
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the procedures to be followed when ordering lab specimens to be processed and/or shipped by research lab at Children’s Health System of Texas (CHST).
2. INTRODUCTION
In pursuit of advancing medical knowledge, clinical research protocols are designed to measure the safety and efficacy of new treatments. Prescribed safety monitoring is included in treatment and non-treatment clinical trials. Taking blood samples is a routine function of safety and efficacy monitoring. Blood samples are often taken to learn more about medical conditions.
Ensuring the quality and validity of the specimen can be achieved by careful review and implementation of the protocol and supporting lab manual for the study. Additionally, it is important for anyone conducting research at CHST to be aware of the procedures for ordering labs. Deviation from the defined procedures can contaminate the sample and obscure the interpretability of the results.
3. SCOPE
This SOP applies to all clinical trials involving laboratory procedures at conducted at CHST.
4. RESPONSIBILITIES
In order that specimen collection can be carried out effectively, the study team, as defined in Children’s Health Clinical Practice Policy 7.12, is responsible for overseeing the processing of lab samples. It is important that the lab requisition forms are drafted with the specifications of the protocol and lab manual and undergo a lab approval and the approval letter filed in the regulatory binder with the essential documents as outlined in R002 and R116. Beyond ensuring the lab processing is carried out appropriately, the lab orders accurately document the time and date of collection and process completion, and as such are subject to audit and used to validate the data on a clinical trial.
All research lab orders are processed through the research lab located in the Main Hospital - C2215. Lab orders are placed in EPIC.
Research Laboratory Director:
Matt Quintero, Research Administration
Contacts:
Email: Researchprocessing@childrens.com Phone: 214-456-2612
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