Page 51 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-003 Title: Initiating the Research Laboratory &
Approval Process
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures to be followed when initiating a research study with the research laboratory at Children’s Health System of Texas (CHST).
2. INTRODUCTION
In pursuit of advancing medical knowledge and innovating the treatments of tomorrow’s clinical research, the research Processing Laboratory has established its policy and procedure to support clinical research at CHST. 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 preparing lab instruction sheets. Lab instruction sheets are formed by the protocol and lab manual, as well as Children’s policy and practice for completing lab samples for research. They outline the procedures for collecting, transferring, processing, and shipping the lab specimen and serve as a means to document and provide a chain of custody for each sample. Deviation from the defined procedures can contaminate the sample and obscure the interpretability of the results.
3. SCOPE
This SOP applies to all persons who conduct clinical trials involving laboratory procedures at CHST.
4. RESPONSIBILITIES
4.1 Lab Feasibility & Approval:
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. Additionally, the Research Processing Lab has defined its procedures in policy GEN 5.13 Clinical Research Lab Sample Processing & Shipping Procedures. It is important that each study involving the processing of specimen for research is carefully appraised for the laboratory procedures required to process and secure valid results. The process is carefully observed through the lab feasibility and approval process set forth by the Research Processing Lab.
4.2 Lab Requestion Forms:
Additionally, as part of the process, 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. Beyond outlining the lab processing instructions, they should be used to accurately documenting the time and date of
Page 2 of 7