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



 
The following is a list of information and documents to be included in the IRB submission packet from the Sponsor/CRO or the Principal Investigator. The Sponsor/CRO may have specific guidelines for how the submission should be handled with Sterling IRB, so please check with them in advance for instructions. A review cannot be performed prior to the receipt of all appropriate information. If you have any questions, please call (888) 636-1062 and a staff member will be glad to assist you.

 

For New Study Design/Protocol Submissions (Sponsor/CRO):

The following documents are required for a new study design/protocol submission. 

 

  • New Study Submission Application (signed by an individual authorized to act in a representative capacity for the Sponsor/CRO)

 

o        For Device Studies:  Submit one of the following:

▪                FDA Investigational Device Exemption (IDE) Letter for the proposed use

▪                FDA Letter granting 510k clearance for the device

▪                FDA pre-market approval (PMA) Letter (with supplement/amendment letters) pertinent to this device   

               application

▪                Letter from Sponsor assessing how/why the device is a non-significant risk (NSR) device

▪                Letter from Sponsor explaining why the device study is exempt from IDE requirements pursuant to

                                  21 CFR 812.2(c)

o        For Investigational New Drug/Biologic: Submit documentation from the FDA verifying the IND number.

o        For Investigational Use of a Marketed Drug/Biologic: Submit documentation from the FDA verifying the IND number.

 

  • New Study Submission Application Form Attachments, if applicable (i.e., SIRB Authorization Agreement, copy of Federal grant and/or contact, Federalwide Assurance, Study-Related/Retention Materials, Certification Letter from Professional Translation Service, etc.).
  • Study Protocol
  • Sub-Study materials and documentation, if applicable
  • Proposed Consent Document(s) (electronic format preferred)
  • Copy of Proposed study-wide Recruitment Materials and Study-Related/Retention Materials (instructions, diaries, etc.)
  • Investigator’s Drug Brochure or package insert (if applicable)
  • Manual of Operations / Instructions for Use – Device Studies (if not a part of the protocol)

 

For New PI/Site Submissions (Principal Investigator):  

The following documents are required for submission of Principal Investigators, either concurrent with the protocol or as a later amendment to the study (for protocols for which Sterling IRB is the central IRB).

 

  • Submission Application for the Investigator/Site  (signed by the Principal Investigator)
  • Submission Application for the Investigator/Site Attachments, if applicable (i.e., FDA 483(s), training certificates, compensation schedule, site SOPs pertaining to the informed consent process, Site-Specific recruitment materials, Financial Disclosure Forms, etc.).
  • Supplemental Site Form(s) with Attachments, if applicable
  • Curriculum Vitae of the Principal Investigator and Sub-Investigator(s) (include a list of previous clinical research experience and publications)
  • Copy of Principal Investigator’s current medical license with expiration date (wallet card acceptable)
  • Copy of Principal Investigator’s DEA Registration (if applicable)
  • Copy of FDA Form 1572 (if applicable)

 

For Amendment to Add/Change Research Site for Previously-Approved Principal Investigator:

The following documents are required to request an amendment to add an additional research site, or to replace an existing research site, for a Principal Investigator who has already received IRB approval. 

 

  • Additional Site Submission Application (signed by the Principal Investigator)
  • Additional Site Submission Application Attachments, if applicable (i.e. IRB Release Letter, FDA 483(s))
  • Copy of new FDA Form 1572 (if applicable)

 

For Amendment to Change Principal Investigator:

The following documents are required to request an amendment for a change of Principal Investigator.

 

  • Submission Application for Change of Principal Investigator (signed by Principal Investigator)

OR

Submission Application for the Investigator/Site (signed by Principal Investigator)

plus Supplemental Site Form(s) (if applicable)

  • Submission Application for Change of Principal Investigator Attachments

OR

Submission Application for the Investigator/Site Attachments

  • Curriculum Vitae of the new Principal Investigator (include a list of previous clinical research experience and publications)
  • Copy of Principal Investigator’s current medical license with expiration date (wallet card acceptable)
  • Copy of Principal Investigator’s DEA Registration (if applicable)
  • Copy of new FDA Form 1572 (if applicable)

 

For New Registry Study Design/Protocol Submissions (Sponsor/CRO):

The following documents are required for a new registry study design/protocol submission. 

 

  • New Study Submission Application (signed by an individual authorized to act in a representative capacity for the Sponsor/CRO)
  • New Study Submission Application Attachments, if applicable
  • Study Protocol
  • Sub-Study materials and documentation, if applicable
  • Proposed Consent Document(s), if applicable (electronic copy and hard copy)
  • Copy of Proposed study-wide Recruitment Materials and Study-Related/Retention Materials (instructions, diaries, etc.)

 

For New Registry Study PI/Site Submissions (Principal Investigator): 

The following documents are required for submission of Principal Investigators, either concurrent with the protocol or as a later amendment to the registry study (for protocols for which Sterling IRB is the central IRB).

 

  • Registry Study Submission Application for the Investigator/Site  (signed by the Principal Investigator)
  • Registry Study Submission Application for the Investigator/Site Attachments, if applicable (i.e., FDA 483(s), IRB Release Letter, Financial Disclosure Forms, etc.).
  • Registry Study Supplemental Site Form(s) with Attachments, if applicable
  • Curriculum Vitae of the Principal Investigator and Sub-Investigator(s) (include a list of previous clinical research experience and publications)
  • Copy of Principal Investigator’s current medical license with expiration date (wallet card acceptable)
  • Copy of Principal Investigator’s DEA Registration (if applicable)
  • Copy of FDA Form 1572 (if applicable)

 

For Amendment to Add/Change Research Site for Previously-Approved Registry Study Principal Investigator:

The following documents are required to request an amendment to add an additional research site, or to replace an existing research site, for a Principal Investigator who has already received IRB approval for a registry study. 

 

  • Registry Study Additional Site Submission Application (signed by the Principal Investigator)
  • Registry Study Additional Site Submission Application Attachments, if applicable (i.e. IRB Release Letter, FDA 483(s))
  • Copy of new FDA Form 1572 (if applicable)

 

For Amendment to Change Registry Study Principal Investigator:

The following documents are required to request an amendment for a change of Principal Investigator for a registry study.

 

  • Registry Study Submission Application for Change of Principal Investigator (signed by Principal Investigator)

OR

Registry Study Submission Application for the Investigator/Site (signed by Principal Investigator)

plus Registry Study Supplemental Site Form(s) (if applicable)

  • Registry Study Submission Application for Change of Principal Investigator Attachments

OR

Registry Study Submission Application for the Investigator/Site Attachments

  • Curriculum Vitae of the new registry study Principal Investigator (include a list of previous clinical research experience and publications)
  • Copy of registry study Principal Investigator’s current medical license with expiration date (wallet card acceptable)
  • Copy of registry study Principal Investigator’s DEA Registration (if applicable)
  • Copy of new FDA Form 1572 (if applicable)

 

 
Please see the Board Meeting Calendar for specific Board meeting dates. All requested information must be received by Sterling IRB 5 business days prior to the scheduled meeting. Please send your submission packet to:

Sterling Institutional Review Board
6300 Powers Ferry Road, Suite 600-351
Atlanta GA 30339
Phone: 770-690-9491
Toll-Free: 1-888-636-1062
Fax: 770-690-9492
Email:

For new studies, notification of Board action will take place within 24 hours of the meeting by phone or email and written notification will typically be sent within 2 business days. For new investigators, written notification of Board action will typically be sent within 2 business days.

  



 

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