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STANDARD OPERATING PROCEDURE Research Administration SOP No: E004
SOP Title: Ad-Hoc, Remedial, or Special Requests for Research Education and Training
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to describe the standard procedures to be followed for ad-hoc and remedial training of investigators and/or Children’s Health System of Texas (CHST) Research Administration (RA) research staff in the absence of Research Educator(s).
2. INTRODUCTION
Children’s Health RA, Corporate Compliance, Department Chairs, and the University of Texas Southwestern (UTSW) Institutional Review Board (IRB) regularly monitor and/or audit human subjects research studies to ensure adherence to federal, state, and institutional requirements. Audit findings may necessitate ad-hoc or remedial training on a range of topics In the current state of Pandemic, the current SOP outlines the provision of opportunities for education and training and resources including office hours where have dedicated time to being available for questions or scheduled meetings.
3. SCOPE
This SOP applies to all ad-hoc, remedial, or special requests for research education and training as provided by the CRE.
This SOP does not apply to any initial, on-going, or other planned trainings provided by the CRE.
4. RESPONSIBILITIES
The RA team leads will assume partial fulfilment of the Research Educator’s responsibilities in this time of Pandemic (see SOP E001).
4.1 Clinical Research Educators, or Interim Research Education Support
To provide and document completion of ad-hoc, remedial, or specially requested education and training.
4.2 Research Administration Leadership
To support the CRE in completing of ad-hoc education and training.
4.3 Clinical Research Supervisors, Managers, or other Leadership
To monitor research and request per the Ad-Hoc, Remedial, or Special Requests for Education and Training Form (Attachment A) education and training.
4.4 Quality Specialists, Corporate Compliance, and Departmental Chair Auditors
To report to Research Administration Leadership and the CRE results of audits which require ad-hoc, remedial, or specially requested training.
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