Page 387 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: E004
SOP Title: Ad-Hoc, Remedial, or Special Requests for Research Education and Training
5. SPECIFIC PROCEDURE
5.1 Scope Ad-Hoc, Remedial, and Special Requests for Education and Training Process
A. Supervisors,Managers,orDepartmentalLeadersRequests
• Supervisors, managers, or departmental leaders complete the Ad-Hoc, Remedial, or Special Research Education Request Form.
• Completed forms should be emailed to Research.Education@childrens.com. The CREs will notify the Director, Research Administration, of all requests.
• The CRE meet virtually with the person submitting the form to assess the educational need and create appropriate content.
• The CRE will document completion of training(s) and provide this documentation to appropriate institutional parties.
B. Education and Training Required as a Result of Audits
• If audit results are received, the CRE will review the information and prepare appropriate educational follow-up with the appropriate parties.
• If necessary, the CRE meet virtually with the auditing office to review the information to validate the educational plan. This validation will include evaluating hospital-wide needs as it relates to the educational plan developed.
• The CRE will document completion of training(s) and provide this documentation to appropriate institutional parties.
C. Education and Training Required as a Result of Reportable Events
• As per hospital policy, all reportable events must be sent to hospital
leadership via ResearchAdverseEvent@childrens.com.
• These events may be forwarded to Research.Education@childrens.com and the CRE will review the information, and prepare appropriate educational follow-up with the appropriate parties.
• If necessary, the CRE will meet with hospital leadership to review the reportable event to validate educational plans. This validation will include evaluating hospital-wide needs as it relates to the educational plan developed.
• The CRE will document completion of training(s) and provide this documentation to appropriate institutional parties.
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