Please be aware that several of our forms have been revised to include information required by the accrediting agency. If you have any questions or require assistance completing the forms please contact our office.

DO NOT SAVE THESE FORMS ONTO YOUR COMPUTER FOR FUTURE USE. PLEASE DOWNLOAD A NEW FORM EACH TIME TO ENSURE YOU ARE USING THE MOST CURRENT FORM. TO SAVE PRIOR TO COMPLETION, RIGHT CLICK ON LINK, SELECT "SAVE TARGET AS" or "SAVE LINK AS."

1. HIPAA Waiver (revised 11/28/06)
   Request for alteration or waiver of research participant's authorization for use/disclosure of protected health information without patient/subject authorization.
   
   All HIPAA Waivers should be submitted to Kellie Smith, Senior Quality Assurance Associate, via fax at 512-442-1882 or to
   

2. New Study Submission Forms
   Project Manager Submission Form (revised 06/29/10) - to be completed by a Sponsor/CRO submitting a multiple-site study. Submit this form to submissions@integreview.com or via fax at 512-442-1882.
   Additional Principal Investigator Submission Form (revised 04/26/10) - to be completed by a Principal Investigator's office who will be participating in a previously approved multiple-site study. Submit this form to submissions@integreview.com or via fax at 512-442-1882.
   Single-Site Submission Form (revised 06/29/10) - to be completed by a Principal Investigator's office for a single-site study. Submit this form to submissions@integreview.com or via fax at 512-442-1882.
   Waiver/Documentation of Informed Consent - To be completed if on the New Study Submission form you select to waive informed consent or waive documentation of informed consent
   
   • IntegReview does not review exempt research
   • Only complete New Study Submissions will be placed on the following week's meeting agenda.
   • Click here to view IntegReview's submission deadlines for full board review of Project Manager and Single-Site New Study
   
   
3. Continuing Review Report Forms
   Project Managers (revised 04/26/10) - to be completed by a Sponsor/CRO submitting continuing review for a multiple-site study.
   Additional Principal Investigator (revised 04/26/10) - to be completed by a Principal Investigator's office for continuing review of their site participating in a multiple-site study.
   Single Site Study (revised 04/26/10) - to be completed by a Principal Investigator's office for continuing review of a single-site study.
   
   Click here to view IntegReview's submission deadlines for full board review of Project Manager and Single-Site New Study
   
   
4. Reinstatement of IRB Approval Form
   This form is to be used when your IRB approval is no longer current resulting from either of the following:
   • Your site allowed IRB approval to expire without submitting continuing review
   • IntegReview administratively closed the study at your site
   • IntegReview suspended IRB approval
   • IntegReview terminated IRB approval
   
   
5. Closure Notification (revised 08/03/09)
   This form to be used to submit notification of study/site closures for previously-approved studies.
   
   
6. Request for Web Board Conference (revised 12/29/04)
   This form is to be used to request a private, password-protected conference on our internet Web Board to receive electronic copies of IRB reviewed/approved study documents. For more information on Web Board conferences CLICK HERE.
   
   
7. 1. Request for Review and Approval (revised 06/29/10)
      
      This form is to be used to submit requests for review and approval of the following study documents for previously-approved studies:
      
      
      • Protocol
      • Informed Consent revisions (if due to change in Principal Investigator or site address(es), submit form #8 listed below)
      • New Informed Consent documents
      • Translated documents or translation requests (appropriate for use with this form)
      
      
   2. Request for Review of IB-Package Inserts Form (revised 04/26/10)
      
      This form is to be used to submit requests for review and approval of the following study documents for previously-approved studies:
      
      
      • Investigator's Brochure(s)
      
      
   3. Request for Review of Recruiting Materials/Other Materials Form (revised 06/29/10)
      
      This form is to be used to submit requests for review and approval of the following study documents for previously-approved studies:
      
      
      • Recruiting materials (revised 10/15/09) (select to view guidelines to assist with IRB approval of recruiting materials to include generic materials).
      • Translated documents or translation requests (appropriate for use with this form)
   
   
8. Investigational Site Revision Request (revised 04/26/10)
   This form is to be used by an Investigator participating in a previously-approved study who is requesting a change in a research site, PI, and other site revisions.
   
   
9. Significant Protocol Deviation Report (revised 10/15/08)
   This form is to be completed upon any protocol deviations occurring at the study site(s) that affect or can potentially affect the safety of subjects.
   
   
10. Request for Review of SAE Reports/Unanticipated Problems & Medical Device Effect Reports (revised 06/29/10)
    This form is to be used to submit requests for review of SAE Reports, Medical Device Effect Reports and Unanticipated Problems for previously-approved studies.
    
    • IntegReview only requires reporting of SAEs when ALL of the following criteria are met: (1) the event is serious in nature, (2) the event is suspected to be associated with the use of the drug or the research procedure, and (3) the event is unexpected (not included in the Investigator’s brochure or informed consent document).
    • IntegReview does NOT require the reporting of IND safety reports, unless they meet the definition of an unanticipated problem [(1) unexpected in terms of severity or frequency, (2) involves risks to participants or others, and (3) is more likely than not related to the research (not limited to the test article or procedures)]
11. Experimental Research Subject's Bill of Rights (Required for California Sites Only) _ English Version
    A copy of this form should be provided to a subject prior to consenting to participate in any medical experiment.
12. Experimental Research Subject's Bill of Rights (Required for California Sites Only) - Spanish Version
    A copy of this form should be provided to a subject prior to consenting to participate in any medical experiment.
13. Criteria for Determining Type of Review Form
    This form is to reference whether subsequent protocol amendments and/or informed consent document revisions are reviewed via full board or expedited review.