Page 376 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022
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STANDARD OPERATING PROCEDURE Research Administration SOP No: E002 SOP Title: Research Colloquia Sessions
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to describe the standard procedures to be followed for planning and coordinating the Research Colloquium sessions (hereafter referred to as “Colloquia”).
2. INTRODUCTION
As per Clinical Practice Policy 7.13 “Approval, Training, and Education of the Research Team” researchers and research professionals must receive on-going education and training concerning human subjects research. The Clinical Research Educator (CRE) provides opportunities for education and training. Research Colloquia are held quarterly or as needed and address topical research themes.
3. SCOPE
This SOP applies to Research Colloquia planned and coordinated by the CRE.
This SOP does not apply to all other education and training opportunities planned and coordinated by the CRE.
4. RESPONSIBILITIES
4.1 Clinical Research Educators
To plan and coordinate the Research Colloquia, to collect attendance metrics, and to evaluate the effectiveness of the Colloquia.
4.2 Research Administration Leadership
To review, modify as needed, and approve Colloquia.
5. SPECIFIC PROCEDURE 5.1 Scope Research Colloquia
A. IdentifyingTopicsandSpeakersforResearchColloquiaVirtualSessions
• As identified by federal authorities as common audit findings, the CRE plans Research Colloquia based on core topics that include:
i. Informed Consent
ii. Research Documentation Requirements
iii. Research Billing
iv. Roles and Responsibilities of the Study Team
• Additional topics may be identified based on audit results, requests from engaged research personnel, or practice/policy updates.
• Continuing Medical Education (CME) and Continuing Nursing Education (CNE) credits may be secured.
B. Schedule a Zoom or Teams meeting in Time of Pandemic
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