Sterling Institutional Review Board

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

Sponsor/CRO

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.

New Protocol Submission (for the Sponsor/CRO)

New Study Submission Application (Effective Date: 01/26/10)

Sterling IRB Authorization Agreement (if applicable)

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 Protocol Submission (for the Sponsor/CRO)

New Study Submission Application (Effective Date: 01/26/10)

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

Sponsor Continuing Review Forms (for Sponsors Only)

Sponsor Continuing Review Status Report

Sponsor Interim Status Update (if required)

Sponsor Final Report

SINGLE-Site Continuing Review Forms (when PI is also Sponsor)

Single-Site Continuing Review Status Report

Single-Site Interim Status Update (if required)

Single-Site Final Report

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

Protocol Changes

Modifications and Amendments Submission Form

Revised Product Information

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)

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.