Page 434 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-106 SOP Title: Research Infusions
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures to be followed for the administration of intravenous (IV) investigational products (IP) that are received at Children’s Health.
2. INTRODUCTION
Team members that will be administering any IP must be a registered nurse (RN) licensed in the state of Texas in compliance with state and federal laws. The RN must have current competencies at Children’s Health for IV medication administration. The study protocol must always be followed. If deviating from the protocol, Principal Investigator (PI) must be notified and deviation approved. In the event of emergent safety issues, do what is necessary for patient safety and notify the PI as soon as possible. The location of infusions should be determined at study start-up and may change throughout the study as needed. Each individual infusion should be coordinated with the clinic/unit the infusion will take place. Follow the clinic/unit’s guidance on scheduling/notifications; via email, EPIC, clinic/unit staff, etc.
3. SCOPE
This SOP applies to all clinical trials conducted at Children’s Health and/or under the purview of Children’s Health Research Administration.
4. SPECIFIC PROCEDURES
4.1 Order and pick-up
Review the Medication Orders SOP for ordering guidelines. Team members who pick up IP and transport to the patient for administration must be delegated to do so on the study Delegation Log. Verify if this team member must be licenced or if any delegated team member of the team can perform this function. Chain-of-Custody documentation will be completed with the IDS staff upon pick-up. Copies of these or other documentation may be given for study subject binder filing. This should be discussed with the sponsor during study start-up.
4.2 IV access
Intravenous access options will be decided by the sponsor and the best option for the patient is determined by the PI. Options include peripheral intravenous device (PIV), port-o-cath (IVAD), or peripherally inserted central catheter (PICC). Verify that the sponsor has approved the access as per the PI determination. Supplies needed for access should be on the study’s SOA.
4.3 IV Pumps
Children’s Health uses the Alaris IV pumps. The main unit, a.k.a. brain, is the Alaris 8015 Point-of-Care Unit. Two secondary units are available, depending on whether the
SOP No. R121, Date: 06/16/2020