Page 237 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-106 SOP Title: Lab Bags/Kits
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures for preparing lab kits for study visits according to expectations outlined in the clinical trial protocol and research processing laboratory at Children’s Health System of Texas (CHST).
2. INTRODUCTION
In pursuit of advancing medical knowledge and innovating the treatments of tomorrow, clinical research protocols monitor 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 preparing lab kits. Deviation from the defined procedures can contaminate the sample and obscure the interpretability of the results.
3. SCOPE
This SOP applies to any person obtaining lab samples for research purposes at Children’s Medical Center.
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. Keeping a record of all lab supplies, orders for lab supplies and shipment tracking information are a priority for complying with GCP and FDA. Documentation of these functions should be kept in the regulatory binders. Additionally, the study team is responsible for preparing the lab specimen collection kits prior to each study visit where lab samples are collected.
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