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.