Page 254 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q015 SOP Title: Quality Specialist Performance
Site Review Study File Management Plan
− Lab & Pathology Support Letter – If applicable, this folder should contain the Lab/Pathology Support e-mail and Lab/Pathology Support letter at the time of PSA request receipt;
− Protocol_IB_MOP_LabManual_Pharmacy Manual – This folder should contain a copy of the protocol, IB, MOP, Lab/Pharmacy manual (if applicable) at the time of PSA request receipt;
− Performance Site Review Form – A copy of the performance site review form saved from Velos will need to be filed;
− SOA – This folder should contain pertinent SOA request e-mails and finalized SOA at the time of PSA request receipt;
− Sponsor Forms_CRFs_1572_IND_Statement of Investigator – This folder should contain copies of sponsor forms including case report forms (data collection form), FDA 1572 (if applicable), IND/IDE letters (if applicable), any pertinent sponsor forms provided by members of the research team at the time of PSA request receipt;
− Staffing Plan – This folder should contain copies of the staffing plan and DOA at the time of PSA request receipt
− Standard Review – If applicable, this folder should contain a copy of the initial SR e-mail request, pertinent milestone e-mails, and final e-mail from SR once device/technology has been approved;
− Synopsis – A copy of the QS summary of the study including questions, concerns, and requests will need to may be saved for reference. It should be noted that a synopsis is not required for “expedited” or “exempt” study PSA request submissions.
− Other Subfolder as needed – Depending on changing environment, it may be necessary to create additional sub-folders. For example, COVID-19 risk mitigation plan requires for each new PSA request to be reviewed and granted approval prior to any research activities taking place at Children’s Health. And, data analytics correspondence and approvals may be housed in their own sub- folder.
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