Page 153 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A017 SOP Title: Virtual Office Navigator
EPIC RBR
The EPIC RRB is a billing report of research related charges generated for research patients registered on research trials through Velos within the CHST system. The report is part of the infrastructure of the EPIC accounting system and is customizable to any person who plays a role in overseeing the study finances across research at CHST.
Regulations and Policies
Below are the list and references for FDA regulations and GCP guidelines pertaining to clinical trials.
21 CFR 312.53
Selecting Investigators and Monitors
21 CFR 312.60
General Responsibilities of Investigators
21 CFR 312.61
Control of the Investigational Drug
21 CFR 312.62
Investigator Recordkeeping and Record Retention
21 CFR 312.64
Investigator Reports
21 CFR 312.66
Assurance of IRB Review
21 CFR 312.68
Inspection of Investigator’s Records and Reports
21 CFR 312.69
Handling of Controlled Substances
21 CFR 812.46
Monitoring investigations
21 CFR 812, Subpart E
Responsibilities of Investigators
21 CFR 812, Subpart G
Records and Reports
21 CFR 812, Subpart D
IRB Review and Approval
21 CFR 814.104
Humanitarian Use Devices, Original Applications
21 CFR 814.124
Investigational Review Board Requirements
21 CFR 54
Financial Disclosure by Clinical Investigators
45 CFR 56
Protection of Human Subjects
Guidance for Industry E6 Good Clinical Practices: Consolidated Guidance http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf
Certificate of Confidentiality
http://grants.nih.gov/grants/policy/coc/index.htm
Policies
Our institution’s policies define the purpose and process of various functions that require additional guidance or consideration of our vulnerable population above the governing laws and regulations. Further, they provide guidance how to complete various functions customary to CHST.
Below is a list of policies pertaining to clinical research at Children’s Health. The full list of CMC policies can be found at http://childrens.policytech.com
Policy #
Name
CP 7.04
Clinical Research Cost Allocation
CP 7.05
Research Rates
CP 7.06
Initiation of Research
AD 7.06
Research Policies
CP 7.12
Responsibilities of the Research Team
CP 7.13
Approval, Training and Education of the Research Team