Please note this important information regarding changes affecting Sponsors/CROs and Principal Investigators.



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 fax, mail or email.

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

All forms must be submitted with an authorized signature. The electronic versions are compatible with Microsoft Word 2000.

 
Please note: Both the Print and Electronic versions are locked for editing original content; however, the electronic version allows you to fill in responses into the inserted grey text boxes.

The print versions of our forms are NOT designed to be filled out electronically, and should only be used for hand written responses. NOTE: Sterling IRB prefers to receive the type-written ('Electronic') version of these forms.

Starting June 1, 2008, Sterling will only accept the new Submission Application found on this page. No previous versions will be accepted after this date.

 


New Protocol Submission (for the Sponsor/CRO)
New Study Submission Application Print Electronic
Sterling IRB Authorization Agreement (if applicable) Print Electronic
New Principal Investigator/Site Submission
Submission Application for the Investigator/Site Print Electronic
Supplemental Site Form(s) (if needed) Print Electronic
Financial Disclosure Form(s) (if needed) Print Electronic
FDA 1572 Form (if applicable) PDF
Application for Waiver of Authorization (if needed) Print Electronic
Application for Partial Waiver of Authorization for Recruitment Purposes (if needed) Print Electronic
Waiver of Informed Consent (if needed) Print Electronic
Waiver of Documentation of Informed Consent (if needed) Print Electronic
Hospital/University IRB Release (if needed) Print Electronic
Sterling IRB Authorization Agreement (if applicable) Print Electronic
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
New Registry Study Protocol Submission (for the Sponsor/CRO)
New Study Submission Application Print Electronic
New Registry Study Principal Investigator/Site Submission
Registry Study Submission Application for the Investigator/Site Print Electronic
Registry Study Supplemental Site Form(s) (if needed) Print Electronic
Financial Disclosure Form(s) (if needed) Print Electronic
FDA 1572 Form (if applicable) PDF
Application for Waiver of Authorization (if needed) Print Electronic
Application for Partial Waiver of Authorization for Recruitment Purposes (if needed) Print Electronic
Waiver of Informed Consent (if needed) Print Electronic
Waiver of Documentation of Informed Consent (if needed) Print Electronic
Hospital/University IRB Release (if needed) Print Electronic
Sterling IRB Authorization Agreement (if applicable) Print Electronic
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
Safety Report Forms
Serious Adverse Event Report Form Print Electronic
Significant Protocol Deviation Report (Including Exceptions) Print Electronic
Unanticipated Problem Report Print Electronic
IND Safety Report Cover Page Print Electronic
Sponsor Continuing Review Forms (for Sponsors Only)
Sponsor Continuing Review Status Report Print Electronic
Sponsor Interim Status Update (if required) Print Electronic
Sponsor Final Report Print Electronic
Site Continuing Review Forms (for PI/Site Only)
Site Continuing Review Status Report
[Replaces 'Annual Review Report']		 Print Electronic
Site Interim Status Update (if required)
[Replaces 'Interval Review Report']		 Print Electronic
Site Final Report Print Electronic
Site Information Changes (for an existing site)
Modification and Amendments to Previously Approved Research Submission Form Print Electronic
Revised FDA 1572 Form (if applicable) PDF
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
Consent Document(s) Changes
Modification and Amendments to Previously Approved Research Submission Form Print Electronic
Revised FDA 1572 Form (if applicable) PDF
Protocol Changes
Modification and Amendments to Previously Approved Research Submission Form Print Electronic
Revised Product Information
Modification and Amendments to Previously Approved Research Submission Form Print Electronic
Add/Change Study-Related Materials
Modification and Amendments to Previously Approved Research Submission Form Print Electronic
Recruitment Items (after initial approval)
Recruitment Materials Submission Form Print Electronic
Screening Script Submission Form Print Electronic
Application for Partial Waiver of Authorization for Recruitment Purposes (if needed) Print Electronic
Add/Change Research Site for Previously-Approved PI
Additional Site Submission Application Print Electronic
Revised FDA 1572 Form (if applicable) PDF
Hospital/University IRB Release (if needed) Print Electronic
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
Change of Principal Investigator
Submission Application for Change of Principal Investigator Print Electronic
Submission Application for the Investigator/Site (if needed) Print Electronic
Supplemental Site Form(s) (if needed) Print Electronic
Financial Disclosure Form (if needed) Print Electronic
Revised FDA 1572 Form (if applicable) PDF
Hospital/University IRB Release (if needed) Print Electronic
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
Add/Change Registry Study Research Site for Previously-Approved PI
Registry Study Additional Site Submission Application Print Electronic
Revised FDA 1572 Form (if applicable) PDF
Hospital/University IRB Release (if needed) Print Electronic
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
Change of Registry Study Principal Investigator
Registry Study Submission Application for Change of Principal Investigator Print Electronic
Registry Study Submission Application for the Investigator/Site (if needed) Print Electronic
Registry Study Supplemental Site Form(s) (if needed) Print Electronic
Financial Disclosure Form (if needed) Print Electronic
Revised FDA 1572 Form (if applicable) PDF
Hospital/University IRB Release (if needed) Print Electronic
Massachusetts Sites Compliance Agreement (if applicable) Print Electronic
Institutional Release
Hospital/University IRB Release (if needed) Print Electronic
HIPAA
Application for Waiver of Authorization Print Electronic
Application for Partial Waiver of Authorization for Recruitment Purposes Print Electronic
Other
Application for IRB Exemption Print Electronic


If you have trouble obtaining any of the above forms/documents
or wish to inquire about additional items, please contact us
at 1-888-636-1062 or e-mail
and our staff will be glad to assist you.
 

© Sterling Institutional Review Board