News & Information


News & Information
1. New Program: Random
    Site Audits
01/26/10
 
2. Updated Policies:
    Cognitively Impaired
    Subjects
01/26/10
 
3. Reportable Events:
   01/26/10


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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.

 

Safety Report Forms (Including Board Requested Response Form)
   Serious Adverse Event Report Form
   Significant Protocol Deviation Report
   Sponsor-Granted Exception Form
   Unanticipated Problem Report
   IND Safety Report Cover Page
   Board Requested Response Form
Site Continuing Review Forms (for PI/Site Only)
   Site Continuing Review Status Report
   Site Interim Status Update (if required)
   Site Final Report
New Principal Investigator/Site Submission
   Submission Application for the Investigator/Site (Effective Date: 02/12/10)
   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)
   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)
New Registry Study Principal Investigator/Site Submission
   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)
   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)
New Application for Humanitarian Use Device (HUD)
   Application for Humanitarian Use Device (HUD)
Humanitarian Use Device (HUD) Continuing Review Forms
   Humanitarian Use Device (HUD) Continuing Review Report
   Humanitarian Use Device (HUD) Final Report
Compassionate Use Continuing Review Forms
   Compassionate Use Continuing Review Report
   Compassionate Use Final Report
Site Information Changes (for an existing site)
   Modifications and Amendments Submission Form
   Revised FDA 1572 Form (if applicable) (external link)
   Massachusetts Sites Compliance Agreement (if applicable)
Consent Document(s) Changes
   Modifications and Amendments Submission Form
   Revised FDA 1572 Form (if applicable) (external link)
Add/Change Study-Related Materials
   Modifications and Amendments Submission Form
Recruitment Items (after initial approval)
   Recruitment Materials Submission Form
   Screening Script Submission Form
   Application for Partial Waiver of Authorization for Recruitment Purposes (if needed)
Add/Change Research Site for Previously-Approved PI
   Add or Change Site Submission Application
   Revised FDA 1572 Form (if applicable) (external link)
   Hospital/University IRB Release (if needed)
   Massachusetts Sites Compliance Agreement (if applicable)
Change of Principal Investigator
   Submission Application for Change of Principal Investigator (Effective Date: 02/12/10)
   Submission Application for the Investigator/Site (if needed) (Effective Date: 02/12/10)
   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)
Add/Change Registry Study Research Site for Previously-Approved PI
   Registry Study Additional Site Submission Application
   Revised FDA 1572 Form (if applicable) (external link)
   Hospital/University IRB Release (if needed)
   Massachusetts Sites Compliance Agreement (if applicable)
Change of Registry Study Principal Investigator
   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)
Institutional Release
   Hospital/University IRB Release (if needed)
HIPAA
   Application for Waiver of Authorization
   Application for Partial Waiver of Authorization for Recruitment Purposes
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.