Sterling Institutional Review Board

News & Information

News & Information

1. Process Change - Receipt
   of Acknowledgments
    Effective 08/01/10

2. SilverLink - 21 CFR 11
   Compliant 04/02/10

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Sterling Institutional
Review Board
6300 Powers Ferry Road
Suite 600-351
Atlanta, Georgia 30339
Toll-Free: (888) 636-1062
Fax: (770) 690-9492

Investigator/SMO

Forms

Sterling IRB provides the following forms for your assistance in the proper execution of business with Sterling IRB. No change should be made to any document without the express written consent of Sterling Institutional Review Board. The forms provided below can be sent to Sterling IRB by mail, fax or email.

Sterling Institutional Review Board
6300 Powers Ferry Rd., Suite 600-351
Atlanta, GA 30339
Fax: 770-690-9492

All forms must be submitted with an authorized signature. These forms are compatible with Microsoft Word 2000 and higher.

Please click on the name of the form you wish to download.

A. New Principal Investigator/Site Submission (including Registry Studies)

Submission Application for the Investigator/Site (Effective Date: 08/02/10)

Supplemental Site Form(s) (if needed)

Registry Study Submission Application for the Investigator/Site (Effective Date: 02/12/10)

Registry Study Supplemental Site Form(s) (if needed)

Financial Disclosure Form(s) (if needed)

FDA 1572 Form (if applicable) (external link)

Application for Waiver of Authorization (if needed)

Application for Partial Waiver of Authorization for Recruitment Purposes (if needed)

Waiver of Informed Consent (if needed) (Effective Date: 05/26/10)

Waiver of Documentation of Informed Consent (if needed)

Hospital/University IRB Release (if needed)

Sterling IRB Authorization Agreement (if applicable)

Massachusetts Sites Compliance Agreement (if applicable)

B. New Application for Humanitarian Use Device (HUD)

Application for Humanitarian Use Device (HUD)

C. Change of Principal Investigator (including Registry Studies)

Submission Application for Change of Principal Investigator (Effective Date: 02/12/10)

Submission Application for the Investigator/Site (if needed) (Effective Date: 08/02/10)

Supplemental Site Form(s) (if needed)

Registry Study Submission Application for Change of Principal Investigator

Registry Study Submission Application for the Investigator/Site (if needed) (Effective Date: 02/12/10)

Registry Study Supplemental Site Form(s) (if needed)

Financial Disclosure Form (if needed)

Revised FDA 1572 Form (if applicable) (external link)

Hospital/University IRB Release (if needed)

Massachusetts Sites Compliance Agreement (if applicable)

D. Add/Change Research Site for Previously-Approved PI (including Registry
Studies)/Site Information Changes

Add or Change Site Submission Application

Registry Study Additional Site Submission Application

Modifications and Amendments Submission Form (Effective Date: 07/09/10)

Revised FDA 1572 Form (if applicable) (external link)

Hospital/University IRB Release (if needed)

Massachusetts Sites Compliance Agreement (if applicable)

E. Amendment/Consent Document(s) Changes

Modifications and Amendments Submission Form (Effective Date: 07/09/10)

Revised FDA 1572 Form (if applicable) (external link)

F. Add/Revise Study-Related Materials/Recruitment Items

Modifications and Amendments Submission Form (Effective Date: 07/09/10)

Screening Script Submission Form

Application for Partial Waiver of Authorization for Recruitment Purposes (if needed)

G. Safety Report Forms/Deviations (including Board Requested Response Form)

Serious Adverse Event Report Form

Significant Protocol Deviation Report (Effective Date: 07/14/10)

Sponsor-Granted Exception Form

Unanticipated Problem Report

IND Safety Report Cover Page

Board Requested Response Form

H. Continuing Review (including HUD/Compassionate Use)

Site Continuing Review Status Report

Site Interim Status Update (if required)

Site Final Report

Humanitarian Use Device (HUD) Continuing Review Report

Humanitarian Use Device (HUD) Final Report

Compassionate Use Continuing Review Report

Compassionate Use Final Report

I. Institutional Release

Hospital/University IRB Release (if needed)

J. HIPAA

Application for Waiver of Authorization

Application for Partial Waiver of Authorization for Recruitment Purposes

K. Other

Application for IRB Exemption

If you have trouble obtaining any of the above forms/documents or wish to inquire about additional items, please contact us at (888) 636-1062 or e-mail us and our staff will be glad to assist you.