Tel: 954.327.0778 | Fax: 954.327.5778 | E-mail: info@iirb.com
Forms

“Comprehensive tools to streamline the submission  process.”
Forms
The Independent IRB, 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 forms for submission in .PDF and .DOC.
Initial Submission Forms
Study Submission Letter (optional) This form is intended as a tool to simplify your submission process by outlining possible documents needed for IRB review.
Study Setup Form provides information for administrative management for the study.
Site Questionnaire Additional Site to Multi-Site Study New study or additional site for a multi-site research study. If Independent IRB, Inc. is not the central IRB, please use the Single Site Questionnaire.
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.
Core Site Questionnaire If the Independent IRB, 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.
Study Specific Questionnaire Submit for each new study, if a Phase 1 Core Site Questionnaire is already on file at Independent IRB, Inc.
Site Questionnaire for “Unconsented” Study Use of Leftover Specimens that are Not Individually Identifiable.
International Addendum Use in addition to the Site Questionnaire when a study is being conducted internationally.
Additional Location/Location Change Form Use in addition to the Site Questionnaire when a study is being conducted at more than one location.
Pregnant Women and Human Fetuses Addendum Use in addition to the Site Questionnaire when a study involves pregnant women and human fetuses.
Research Involving Children Addendum Use in addition to the Site Questionnaire when a study involves children.
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.
Multiple-Center Research (SMO) Form Use in addition to the Site Questionnaire if the study is being conducted at more than one location that are not affiliated or if a Site Management Organization (SMO) is being used in the study. (A SMO is a person that assumes, as an independent contractor with a clinical investigator, one or more of the regulatory obligations of a clinical investigator, e.g. preparation and maintenance of case histories, ensuring compliance with IRB review).
FDA Form 1572 Submit for FDA regulated studies as applicable.
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.
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.
Request for Exemption Determination Submit for exemption determination.
Reporting Changes To Ongoing Research
Change in Principal Investigator Use when submitting a change in Principal Investigator.
FDA Form 1572 Submit for FDA regulated studies as applicable.
Additional Location/Location Change Form Use when submitting a change in location.
Problems in Research Reporting Form(new) Use this form to evaluate protocol deviations, adverse events (AEs), serious adverse events (SAEs), unanticipated adverse device effects (UADEs), IND Safety Reports, and other issues or problems that may be identified. This form is intended to help you determine if an event/problem needs to be reported to the Independent IRB, Inc.
Continuing Review And Study Closure
Progress Report Submit prior to expiration of approval for continuing review.
Study Close Out Report Submit prior to expiration of approval for study closeout.
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.
Multi-Site Continuing Review Report
Multi-Site Progress Report Form To be submitted by the site for multi-site research studies, where the Independent IRB, Inc. is the central IRB for multiple research sites.
Other Resources And Forms
Investigator's Guidebook
IIRB's Compliance Statement
FDA Audit Letter  
Note: Click on the category you want to expand the list.

If you do not have Adobe Acrobat to review and print PDF forms, click here to download it.
If you do not have Microsoft Word to review and print DOC forms, click here to download Microsoft Word Viewer.

If you would prefer that these forms be mailed or faxed to you, or if you have any questions, or would like assistance, please contact us.