Initial Submission Guidelines

The following is a list of information and documents to be included in the IRB submission packet from the Sponsor/CROs and Principal Investigators. 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
    • For studies involving an Investigational Device: Submit one of the following:
      • FDA Investigational Device Exemption (IDE) Letter verifying the IDE number for the proposed use (if this is not provided, a protocol from the Sponsor imprinted with the IDE number for the proposed use must be provided)
      • 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)
  • New Study Submission Application Form Attachments, if applicable (i.e., Copy of Federal grant application and/or contract, Expedited Review Request Form, No Objection Letter and Trial Registration (for studies being conducted in Canada), Certification Letter from Professional Translation Service, etc.)
  • Study Protocol (complete DHHS-approved protocol, where this exists)
  • Sub-Study materials and documentation, if applicable
  • Proposed Consent Document(s) (DHHS-approved sample consent document, where this exists) (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
  • Submission Application for the Investigator/Site Attachments, if applicable (i.e., clinical trial budget (for Canadian sites), FDA 483(s), compensation schedule, Site-Specific recruitment materials, Financial Disclosure Forms, etc.)
  • Supplemental Site Form(s) with Attachments, if applicable
  • Curriculum Vitae of the Principal Investigator unless a current CV has been submitted to Sterling IRB within the last 2 years <(include previous clinical research experience, education and training)
  • Copy of Principal Investigator’s DEA Registration (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
  • New Study Submission Application Attachments, if applicable
  • Study Protocol
  • Sub-Study materials and documentation, if applicable
  • Proposed Consent Document(s), if applicable (electronic copy preferred)
  • 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
  • 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
  • Copy of Principal Investigator’s DEA Registration (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: This email address is being protected from spambots. You need JavaScript enabled to view it.

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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