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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q008
SOP Title: Expanded Access Program / Compassionate Use Protocols
• Assigned Quality Specialist(s) will review the study staff approved by the IRB for credentialing / training completions, noting any deficiencies and contacts for completion
• Assigned Quality Specialist(s) will review the study documentation in the eIRB
• Assigned Quality Specialist(s) will create an executive summary and provides
supporting documents (i.e. protocol, IB, etc.) to Medical Director of Research Administration for review. Given that subjects may need to be registered in Velos and linked to the EMR, the Medical Director of Research Administration at Children’s will need to create a status update in Velos in order for members of the research team to activate the study in Velos and be able to register subjects.
• Assigned Quality Specialist(s) will send the Acknowledgement letter below to Principal Investigator to file in their study regulatory documents
SOP No. 7, Date: 4/20/16, 11/29/18; 08/19/21, 05/31/22
