Page 414 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R117 SOP Title: Sample and Processing
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures to be followed for how to prepare for study samples as part of research study requirements.
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. If a research study requires any samples to be collected as part of the study protocol, the sample will need to be handled according to specific guidelines to be processed adequately. The procedures for processing lab samples are informed 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 Children’s Health System of Texas (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 processing the labs, the lab requisition sheets 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.
Laboratory Basics:
Research Lab (2ND Floor): 7:00am-3:30pm, Monday-Friday (closed on holidays) Core Lab (1st Floor): 24 hours/7 days a week
NOTE: Research Samples received in the lab after 3:00 should be delivered to the main lab on the 1st floor. If shipping is involved, the coordinator is responsible for packing and shipping.
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