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Institutional Policies and Procedures (HRPP)
2018 Common Rule Standard Operating Procedures
Created Date
:
1/19/2019 11:52 PM
Type
:
(.
pdf
file)
Common Rule - Does it apply to my study? ( 2019)
Created Date
:
2/6/2019 3:33 PM
Type
:
(.
pdf
file)
Compliance in the Conduct of Human Research SOP 9-13-18.pdf
Created Date
:
10/5/2018 1:54 PM
Type
:
(.
pdf
file)
Conflict of Interest (1).pdf
Created Date
:
10/5/2018 1:20 PM
Type
:
(.
pdf
file)
Data Ownership Policy.pdf
Created Date
:
10/5/2018 1:22 PM
Type
:
(.
pdf
file)
External Audits of Human Subjects Research.pdf
Created Date
:
10/5/2018 1:21 PM
Type
:
(.
pdf
file)
Institutional Conflicts of Interest in Research and Clinical Care.pdf
Created Date
:
10/5/2018 1:21 PM
Type
:
(.
pdf
file)
Institutional Oversight of Human Research.pdf
Created Date
:
10/5/2018 1:25 PM
Type
:
(.
pdf
file)
Intake Review and Approval of Industry-Sponsored Human Subjects Research.pdf
Created Date
:
10/5/2018 1:20 PM
Type
:
(.
pdf
file)
Internal Post-approval Monitoring of Human Subjects Research.pdf
Created Date
:
10/5/2018 1:23 PM
Type
:
(.
pdf
file)
Investigational FDA Conditionally Approved Medical Devices Policy.pdf
Created Date
:
10/5/2018 1:22 PM
Type
:
(.
pdf
file)
IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20.pdf
Created Date
:
10/30/2019 12:39 PM
Type
:
(.
pdf
file)
Policy on Quality Conduct of Clinical Research.pdf
Created Date
:
10/5/2018 1:25 PM
Type
:
(.
pdf
file)
Policy on Research Integrity 2017.pdf
Created Date
:
10/5/2018 1:24 PM
Type
:
(.
pdf
file)
Retention and Destruction of Human Subjects Research Data and Records.pdf
Created Date
:
10/5/2018 1:24 PM
Type
:
(.
pdf
file)
Sponsor Monitoring of Human Subjects Research.pdf
Created Date
:
10/5/2018 1:23 PM
Type
:
(.
pdf
file)
Standard Operating Procedure on Registration of Clinical Trials in clinicaltrials.gov.pdf
Created Date
:
10/5/2018 1:22 PM
Type
:
(.
pdf
file)
Statement of IRB Compliance(WFUHS.pdf
Created Date
:
10/5/2018 1:26 PM
Type
:
(.
pdf
file)
WFUHS Guidance Document- External IRB and WF Facilitated Review
Created Date
:
3/19/2019 12:34 PM
Type
:
(.
docx
file)
FWA Assurance Links for:
Wake Forest University Health Sciences
Wake Forest University (Reynolda Campus)
Human Subject Protection Certification
Certification Listing in eIRB
CITI Program in the Protection of Human Research Subjects
ICH-GCP Training
Important Documents
2021 IRB Meeting Calendar.pdf
Common Rule Slides 2019
eIRB User Guide
IRB FEES current 2020.pdf
WFU Reynolda Campus FWA and IRB Numbers
WFUHS FWA and IRB Numbers
Resources
The following websites are resources for individuals who work with human subjects. These sites will provide you with an understanding of the Federal Regulations for Human Subjects Research as well as an ethical background for practicing research.
45 CFR 46 (The Common Rule)
Belmont Report
FDA Information Sheets
Human Subjects Research Decision Charts
Office for Human Research Protection (OHRP)
Information Security
Information Security Resources
Information Security Documents
WFUHS eIRB Security and Data Management Statement.pdf
Information Security Links
WFUBMC Information Security (internal access)