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Submission Guidelines for Full Board Review Studies

New Studies

Documents to be submitted (*as applicable):

  • Study Application (with PI original signature)
  • Consent Form(s) (typical consent form, information sheet, assent form)
  • Protocol*
  • Investigator's Brochure*
  • Promotional Materials*
  • Data collection tools
  • Financial Disclosure forms for all PI, Co-PI, and study staff for funded studies
  • CV/Resume for PI only (unless already on file in the IRB office)
  • Human Participant Protection training certificates for all investigators and study staff (unless already on file in the IRB office)
  • Administrative Attachment* (if more space is needed for study staff)

Documents should be submitted as follows:

  • Original plus 13 copies (copied double-sided).
  • Collated in the order as they appear above.

Annual Renewal

Documents to be submitted:

  • Annual Renewal Report form.
  • Current approved consent form* (1 copy)
  • Information that has not yet been submitted to the IRB for review (preliminary outcome data, if available, audit reports, etc.)
  • Financial Disclosure forms for all PI, Co-PI, and study staff for funded studies

Documents should be submitted as follows:

  • Original plus 13 copies (copied double-sided).

*Continuing review of research previously approved by the convened IRB (Full Board Studies) may be reviewed by expedited review when one of the following criteria is met:

  1. Where the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects.
  2. Where subjects have been enrolled and no additional risks have been identified.
  3. Where the remaining research activities are limited to data analysis.

Study Updates/Amendments

Documents to be submitted:

  • Update/Amendment Report form.
  • Update and/or Amendment
  • Consent Form (if changes were required with tracked changes or highlighted changes)
  • Any new or changed financial disclosure forms that have been discovered since study approval or renewal.

Documents should be submitted as follows:

  • Original plus 13 copies (copied double-sided).
  • Only make copies of the update/amendment for the IRB Board, if the changes required modifications to the consent. Copy only those pages describing the changes.
  • Only copy the pages of the consent that required modifications. Highlight the changes.

Adverse Events/Safety Reports/Safety Information

Documents to be submitted:

  • Adverse Event Form.
  • Supporting documentation including a complete copy of the adverse event/safety report and/or safety information in the form of an ADEERS or MEDWATCH report

Documents should be submitted as follows:

  • FOR LOCAL ADVERSE EVENTS ONLY: Original Adverse Event form with supporting documentation plus 13 copies (copied double-sided).
  • For external Adverse Events: Original Adverse Event form with supporting documentation

Closure Report

Documents to be submitted:

  • Closure report form.
  • Final report/abstract/presentation, etc.

Documents should be submitted as follows:

  • Original plus 13 copies (copied double-sided)

NOTES:

  • Use assigned IRB ID# on post-approval form submissions.
  • All forms must be typed and have legible signatures or they will be returned.

 

 
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