Page 175 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)
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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q008
SOP Title: Expanded Access Program / Compassionate Use Protocols
• Quality Specialist(s) reviews the study staff approved by the IRB for credentialing / training completions, noting any deficiencies and contacts for completion
• Quality Specialist(s) reviews the study documentation in the eIRB
• Quality Specialist(s) creates 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.
• 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
