Page 394 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
1. PURPOSE
Research Administration SOP No: E006
SOP Title: Initial Education and Training for New Researchers and Research Staff engaged at Children’s Health
The purpose of this standard operating procedure (SOP) is to describe the standard procedures to be followed for educating of investigators and/or Children’s Health System of Texas (CHST) Research Administration (RA) research staff who are engaged, per the Office of Human Research Protections definition, in human subjects research at Children’s Health.
2. INTRODUCTION
Children’s Health is responsible for ensuring that all staff who are engaged in human subjects research at the institution has the appropriate education, training, and expertise to comply with federal, state, and institution requirements for conducting human subjects research. The Clinical Research Educator (CRE) designated to the Research Administration (RA) department are an integral part of this strategic priority. In the current state of Pandemic, the current SOP outlines the provision of opportunities for training of personnel engaged in human subjects research, including initial education and training opportunities to set a base-level of knowledge. Participation of all staff is highly encouraged to certify that this institutional responsibility is met.
3. SCOPE
This SOP applies to the initial training and education opportunities planned and coordinated by the CRE.
This SOP does not apply to ongoing educational opportunities planned and coordinated by the CRE.
4. RESPONSIBILITIES
The following outlines the Research Educator’s responsibilities in this time of Pandemic including initial research education.
4.1 Clinical Research Educators
To plan, organize, and manage classes for initial education and training for all persons engaged in human subjects research at Children’s Health.
4.2 Research Administration Leadership
To work with the CRE to review plans, approve of content, and provide support to ensure success of planned.
5. SPECIFIC PROCEDURE
5.1 Scope, Initial Education and Training Process
A. Developing and Planning Curriculum
• The CRE will regularly review content curriculum for initial education and training to assess accuracy of information and will update content as
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