Page 404 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R116 SOP Title: Lab Requisition Sheets
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures to be followed when creating lab requisition sheets, or instructions for completing lab samples for research 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, 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
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 outlining the lab processing instructions, they should be used to accurately document the time and date of collection, processing, storing, and shipping. They are essential for providing a chain of custody and are subject to audit and used to validate the data on a clinical trial.
5. SPECIFIC PROCEDURE
In order to create a lab instruction sheet you will need sponsor provided documents such as the lab manual, manual of operations, or protocol. There are specific instructions that will need to be transferred to the lab instruction sheet.
5.1 Finding the Lab Instruction Template:
Upon receiving a lab approval letter from the lab review completed by Matt Quintero (Elias.Quintero@childrens.com) you will be given a lab requisition template to complete and submit for review). Once reviewed, your approved lab requisition sheets with a
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