The Independent Investigational Review Board, Inc. has designed these forms to be user-friendly and to address the requirements established by the Regulatory authorities. However, we welcome your comments and feedback as we are committed to continuous quality improvement.

You can download and print the following PDF forms for submission.


Study Submission Letter (optional) This form is intended as a tool to simplify your submission process by outlining possible documents needed for IRB review.
PDF [164k] | Word Doc [182k]

Study Set Up Form provides information for administrative management for the study.
PDF [50k] | Word Doc [109k]

Site Questionnaire Additional Site to Multi-Site Study
New study or additional site for a multi-site research study.
PDF [174k] | Word Doc [360k]

Single Site Questionnaire
New study for IRB review. Please note this is not applicable if you have a Phase 1 Core Site Questionnaire on file.
PDF [177k] | Word Doc [374k]

Phase 1 Core Site Questionnaire
If the IIRB, Inc. is your IRB of choice, you can submit a Phase 1 Core Site Questionnaire once a year, and a Phase 1 Study Specific Questionnaire with each new study submission. May include later stage research if conducted at the clinic site.
PDF [175k] | Word Doc [536k]

Phase 1 Study Specific Questionnaire
Submit for each new study, if a Phase 1 Core Site Questionnaire is already on file at IIRB, Inc.
PDF [103k] | Word Doc [451k]

Site Questionnaire for “Unconsented” Study
Use of Leftover Specimens that are Not Individually Identifiable
PDF [93k] | Word Doc [268k]

International Addendum
Use in addition to the Site Questionnaire when a study is being conducted internationally.
PDF [41k] | Word Doc [203166k]

Additional Location Form
Use in addition to the Site Questionnaire when a study is being conducted at more than one location.
PDF [92k] | Word Doc [212k]

Pregnant Women and Human Fetuses Addendum
Use in addition to the Site Questionnaire when a study involves pregnant women and human fetuses.
PDF [47k] | Word Doc [203k]

Research Involving Children Addendum
Use in addition to the Site Questionnaire when a study involves children.
PDF [116k] | Word Doc [234k]

Data Safety Monitoring Plan (optional)
If the protocol does not address data safety monitoring, you can use this form to submit this information or can include this information on the Site Questionnaire.
PDF [39k] | Word Doc [165k]

Multiple-Site Research Form
Use in addition to the Site Questionnaire if the study is being conducted at more than one location that are not affiliated.
PDF [40k] | Word Doc [170k]

FDA Form 1572
Submit for FDA regulated studies as applicable.
PDF [56k] | Word Doc [495k]

Facility Waiver
For use when a study is being conducted at a hospital, outpatient center, or other facility that is under the oversight of an IRB other than IIRB, Inc.
PDF [41k] | Word Doc [185k]

Site Conflict of Interest and Disclosure Form
Submit when the Principal Investigator, research staff, or their immediate family have a conflict of interest with a study.
PDF [104k] | Word Doc [187k]

Request for Exemption Determination
Submit for exemption determination.
PDF [52k] | Word Doc [226k]



FDA Form 1572
Submit for FDA regulated studies as applicable.
PDF [56k] | Word Doc [495k]

Change in Principal Investigator
Use when submitting a change in Principal Investigator.
PDF [83k] | Word Doc [203k]

Protocol Deviation Report Form
PDF [103k] | Word Doc [170k]

Serious Adverse Event Report Form
PDF [44k] | Word Doc [177k]

Pregnancy Notification
PDF [42k] | Word Doc [177k]

Unanticipated Problem Form
PDF [110k] | Word Doc [201k]

Additional Location Form
Use when submitting a change in location.
PDF [92k] | Word Doc [212k]



Progress Report
Submit prior to expiration of approval for continuing review.
PDF [66k] | Word Doc [428k]

Study Close Out Report
Submit prior to expiration of approval for study closeout.
PDF [46k] | Word Doc [319k]

Progress Report/Study Closeout for Leftover Specimens that are Not Individually Identifiable
Use for continuing review or study closeout of studies with Leftover Specimens that are Not Individually Identifiable
PDF [49k] | Word Doc [199k]



IIRB, Inc. 2008 Meeting Calendar
PDF [49k] | Word Doc [179k]

Investigator's Guidebook
PDF [244k] | Word Doc [387k]

Current Membership Roster
PDF [62k] | Word Doc [176k]

Compliance Statement
PDF [62k]

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If you would prefer that these forms be mailed or faxed to you, or if you have any questions, or would like assistance, please don't hesitate in calling.