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".

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 Trina Anderson, Quality Assurance Associate, via fax at 512-442-1882 or to
   

2. New Study Submission Forms
   Project Manager Submission Form (revised 6/13/08) - 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 6/13/08) - 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 6/13/08) - to be completed by a Principal Investigator's office for a single-site study. Submit this form to submissions@integreview.comor 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.
   • IntegReview's deadline for full board review of Project Manager and Single-Site New Study Submissions is Wednesday, 12:00 (noon) Central Time.
   • IntegReview’s deadline for full board review of Additional PI New Study Submissions is Tuesday, 12:00 (noon) Central Time.
   • IntegReview’s deadline for New Study Submissions that qualify to be reviewed by our expedited review process is Tuesday, 12:00 (noon) Central Time.
   
   
3. Continuing Review Report Forms
   Project Managers (revised 1/14/08) - to be completed by a Sponsor/CRO submitting continuing review for a multiple-site study.
   Additional Principal Investigator (revised 3/31/08) - 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 3/31/08) - to be completed by a Principal Investigator's office for continuing review of a single-site study.
   
   IntegReview's deadline for all of the above continuing review submissions is Wednesday, 12:00 (noon) Central Time.
   
   
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. Site Closure Notification (revised 12/11/07)
   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. Request for Review and Approval (revised 1/8/08)
   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 PI or site address(s) submit form #7 below)
   • New Informed Consent documents
   • Investigator Brochure
   • Translated documents or translation requests
   • Recruiting materials (select to view guidelines to assist with IRB approval of recruiting materials)
   
   
8. Investigational Site Revision Request (revised 5/20/08)
   This form is to be used by an Investigator participating in a previously-approved study who is requesting site, PI, and/or Form FDA 1572 revisions.
   
   
9. Significant Protocol Deviation Report (revised 12/18/07)
   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/IND Safety/Medical Device Effect Reports (revised 4/29/08)
    This form is to be used to submit requests for review of SAE, IND Safety and Medical Device Effect Reports for previously-approved studies.
    
    
11. Unanticipated Problem Form (revised 12/18/07)- This form is to be used to submit requests for review of unanticipated problems that involve risks to participants or others. An unanticipated problem is any problem that is (1) unforeseen and (2) either caused harm to participants or others or indicates that the risks to participants or others is increased.