Check List Chart Review Or Data Collection 1

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					                                                                         INSTITUTIONAL REVIEW BOARD
                                                          CHART REVIEW / DATA COLLECTION CHECK LIST

An application for IRB review of a research protocol involving human subjects should include the following
information. All applications require items that are marked with an asterisk (*). Additional items should be submitted if
applicable to a particular protocol. Incomplete/outdated applications will NOT be reviewed, and will be returned
to the investigator for completion. If you have any questions, please contact the IRB Office at 414-266-7454.

 Only the following individuals may serve as the principal investigator in the conduct of clinical research at CHW
  Affiliates: CHW Affiliates Medical/Dental staff member in good standing, CHW Affiliates employee, or CRI
  Investigator. Students, residents, and fellows must have a CHW medical/dental staff member, CHHS employee, or
  CRI Investigator listed as a co-principal investigator or co-investigator on the study team. If a study requires patient
  care tests, procedures or medications and is conducted at a CHW Affiliates site, a member of the Medical/Dental
  Staff or employee of CHW Affiliates must serve as a principal investigator for the study. Non-Medical/Dental staff
  members, who are approved by Children’s Research Institute, may independently serve as a principal investigator
  on studies that do not involve medical or surgical tests, procedures or medications.
 ALL DATA IS TO BE EXISTING AT THE TIME OF APPROVAL. If Investigator's are using prospective
  data, consent, assent (if applicable) and HIPAA Authorization forms should be developed and the Expedited
  Review Check List should be used.
  more than minimal risk to the subjects, will not adversely affect the rights and welfare of the subjects and the
  research could not practicably be done without the waiver.
 A consultation with Data Management prior to submission is recommended.
 Any data that will you be requesting from Data Management must be written exactly the way it will be
  requested in the Chart/Data Review Form, the Data Collection Sheet or the HIPAA Waiver Form.
 When a chart review / data request is approved, it should have a 2-year life span (including data analysis). The
  Principal Investigator should provide an explanation of why the study should remain open at the time of continuing
 If the IRB Chair or designee reviewer believes that a protocol should not be approved and feels any level of
  discomfort in his / her review, the study must be referred to the full IRB for consideration.
[ ]     Cover Memo
[ ] * Category of Expedited Review Form
[ ] * Registration Form using the IRBNet Wizard (Conflict of Interest Form included; signatures are electronic)
[ ] * Certificate of completion of CITI training on the Protection of Human Research Subjects for ALL
        Investigators and research personnel, if not previously submitted. Once initial certification is obtained,
        the CITI Refresher Course must be completed every two years.
[ ] * Copy of signed Code of Ethics document for ALL Investigators and research personnel, if not
        previously submitted.
[ ]     CHW Shared IRB Review Form (for studies being done at both CHW and Froedtert).
[ ]     Letter of Support From the Director of Human Resources or Designee - If subjects are employees of
        Children’s Health System, a letter of support from CHW’s HR Department should be provided. If subjects
        are residents, a letter of support from MCW’s HR Department should be provided.
[ ]     Curriculum Vitae of Principal Investigator(s) (if not CHW/MCW Staff Member)
[ ]     Budget and Contract (if applicable)
[ ]     Preparatory Research Form (should be e-mailed to Anna D’Amato)
[ ] * Chart / Data Review Form
[ ] * Data Collection Sheet
[ ] * HIPAA Waiver Form
[ ]     Complete Grant Application, Multi-Center or Industry-Sponsored Protocol, Investigators' Brochure


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