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Submission of studies for review will be "first come, first served". Once your study has been assigned to a meeting, you will be notified via email the week before the meeting date.
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1 copy:
Clinical Sciences Pre-Review of Research Proposal IRB Submission Memorandum
2 copies (if applicable):
Protocol (submit the research plan for a test article provided by the sponsor. For investigator-initiated research, see this separate file protocol guidelines. For a tissue procurement service or cell/tissue/DNA repository, submit a protocol following the protocol template (for tissue procurement services or cell/tissue/DNA repositories).
Investigator's brochure (information about a test article provided by the sponsor),
Grant
Questionnaires.
25 copies (COLLATED) plus originals (if applicable) :
IRB Form NR-1,
Project Summary - for a tissue procurement service or cell/tissue/DNA repository, do not submit a project summary. Instead, submit a protocol following the protocol template (for tissue procurement services or cell/tissue/DNA repositories).
Consent Form(s),
HIPAA form(s),
Recruitment notices (all materials used to communicate with potential subjects).
REMINDER: Please complete the NR3 for applicable performance sites using ERGO. Please note, site approvals are not needed prior to IRB review or approval.
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Collated Materials
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IRB
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Ambulatory Services
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CMC
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PHHS
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TSRHC
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Zale Lipshy/
St. Paul
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IRB original packet:
NR1 (original signatures), Project Summary, Consent Form
(stapled as 1 document)
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1
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ERGO*
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IRB copy packets:
NR1 (copy), Project Summary, Consent Form
(stapled as 1 document)
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25
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ERGO*
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ERGO*
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ERGO*
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1
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ERGO*
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Form NR3
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ERGO*
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ERGO*
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ERGO*
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ERGO*
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Protocol
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2
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ERGO*
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ERGO*
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Investigator's Brochure
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2
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ERGO*
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Recruitment Notices
(included within the IRB packet)
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25
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ERGO*
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Grant
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2
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ERGO*
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Other
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*Documents will be attached to the ERGO NR3 From.
For questions regarding submission of documents, please contact:
Ambulatory Services - Julie Landesberg at 214-648-2024, mail code 8831, or at Julie.Landesberg@UTSouthwestern.edu.
Children's Medical Center - Karen Meador, MD, MBA, at 214-456-6096, mail code CDCD P3-168, or at Karen.Meador@Childrens.com.
Parkland Health & Hospital System - Valeria Hart, RN, PhD, at 214-590-8966, mail code 7750 or at VHart@parknet.pmh.org.
Texas Scottish Rite Hospital - Richard Browne, PhD, Research Program Administrator, at 214-559-7879 or at richb@tsrh.org.
University Hospitals - Zale Lipshy/St. Paul - Cindy McCalla at 214-645-1121, St. Paul Administration or at Cindy.McCalla@UTSouthwestern.edu.
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