Page 395 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: E006
SOP Title: Initial Education and Training for New Researchers and Research Staff engaged at Children’s Health
necessary to reflect the current state of affairs for conducting research at Children’s Health.
• This content includes but is not limited to:
i. “Research at Children’s Health” PowerPoint presentation
ii. eResearch Access Request*
iii. Velos/eIRB Study Registration^
iv. eIRB*
v. Children’s Medical Center Dallas Research Pricing Quote Form*
vi. Velos Coverage Analysis Study Team^
vii. Velos Request Performance Site Approval^
viii. Performance Site Approval*
ix. Office of Clinical Research Facilitation (OCRF) Requirements for Velos Studies^
(* denotes a Quick Reference Guide owned by UTSW; ^ denotes a Tip Sheet owned by the CRE)
• The CRE will report as needed to the Director, Research Administration, regarding updates to the content for initial education and training.
B. Advertisement and Event Registration
• The CRE will create events WebEx where prospective attendees can register for the event (see SOP E001).
• The CRE will send an email to their contact list (containing engaged research personnel from Children’s Health, the University of Texas Southwestern (UTSW), Parkland Hospitals, and the Texas Scottish Rite Hospital for Children) to announce the planned education and training session in advance of each class.
C. OnlineLearningManagementSystemModules
• All staff engaged in human subjects research at Children’s Health must complete the following computer-based training (CBT) research-related courses:
i. Research Compliance: Children's Medical Center As A Performance Site v1.0
ii. Research Compliance: Overview, Roles & Responsibilities v1.0
• All staff engaged in human subjects research at Children’s Health must attend or complete the following courses as per their credentials in order to access and utilize EPIC, the electronic medical record system:
i. Licensed Research Staff (e.g., RN, RRT, MA, etc.)
1. EPIC Inpatient - Inpatient 101 v3.0
2. EPIC Ambulatory - Clinical v1.0
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