Page 217 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R100 SOP Title: Ordering Study Supplies
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures to be followed when: ordering, receiving, maintaining, and disposing of research study medical supplies.
2. INTRODUCTION
Research Administration (RA) is dedicated to being good stewards of its resources while protecting its patient population and staff by standardizing how study related medical supplies are ordered, received, maintained and disposed.
This SOP applies to all research study personnel who order or otherwise handle study related medical supplies at Children’s Health System of Texas (CHST).
3. RESPONSIBLE PARTIES
3.1 Research Study Personnel
Research Study Personnel who conduct research studies that generate study related medical supplies will follow the procedures outlined in this SOP.
3.2 Research Business Service Director
The Research Business Service Director will ensure that research studies requiring study related medical supplies not provided by the sponsor/contract research organization (CRO) will be accurately procured for and billed.
4. SPECIFIC PROCEDURE
4.1 Ordering Study Related Medical Supplies
• For study related medical supplies provided by study sponsor/CRO:
o Follow documented process flow provided by the sponsor when
ordering or re-ordering study related medical supplies.
o If a sponsor provided process flow does not exist, contact the study sponsor/CRO for ordering details. Place the sponsor/CRO provided details into the regulatory binder for future reference.
• For study related medical supplies not provided by study sponsor/CRO:
o Ensure that the most recent study service order agreement (SOA) includes funds for medical supplies. Contact the Research Finance Director to assist in determining the availability of funds prior to ordering study related medical supplies.
o Email your Team Leader, Research Finance Director and RA supply contact person that study related medical supplies are needed for a study and include the following information:
§ an exact description (size, color, quantity, etc.) of the supplies being requested
§ Omni cell number/Lawson item number