Page 100 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
6. RESOURCES 6.1 Contacts
Research Administration SOP No: A010 SOP Title: RA Contracts
Contract type
Contact
Email
FUA, SOA
Contracts Management
ContractAdmin@childrens.com
DUA, FUA
Legal
Lisa.Frenkel@childrens.com
Reliance Agreements
Victoria Brown
Victoria.Brown@childrens.com
RedCap Database
https://redcap.childrens.com/redcap/index.php
6.2 Definitions
IRB Authorization Agreement (IAA)
This is an agreement between Children’s Health and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP). This agreement type is used to establish which institution will serve as the IRB-of- Record.
Master Reliance Agreement
This agreement is utilized when multiple studies cede review to a specific external IRB. Master Reliance Agreements may be for a single protocol or a number of protocols that are negotiated on a case by case basis.
Memorandum of Understanding (MOU)
An MOU is used to acknowledge an ongoing relationship between institutions. It is intended to be a long- term agreement and/or to support a specific research study. The agreement generally describes a very broad concept of mutual understanding, goals, and plans shared by the parties. It may also list areas of possible joint activities, without creating financial obligations or committing resources.
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