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For modifications to research determined to be exempt (whether reviewed by exempt procedures or limited IRB procedures), the following materials must be submitted via the NIH electronic IRB system. For any forms or documents being uploaded, include the word "exempt" in the title.

• Modification Submission Form including applicable changes
• Revised research project
• Other revised documents, as applicable:
  1. Revised information sheet, verbal script, etc.
  2. Revised recruitment material, as applicable (e.g., flyers, posters, scripts, social media ads), as applicable
  3. Revised study instruments used to collect data from research subjects (e.g., surveys, interview forms, questionnaires, assessments)
• Any other documents or information that the IRBO requests

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The process for adding non-NIH participating sites (pSites) in the electronic IRB system is described in the manuals available on the IRBO webpage with eIRB Training and User Guides.  When within the PROTECT system's Library tab. When the NIH IRB is the Reviewing IRB, and you are adding a participating site, whether to initiate multi-site research or to expand an existing multi-site protocol, make certain the modification includes the following documentation:

• Submit Basic Site Information using the eIRB submission form.

• Upload supporting documents in the eIRB system including the following:

      1. pSite Protocol Addendum (using the IRBO template);

      2. pSite Consents/ Assents (if applicable);

      3. pSite Recruitment materials (if applicable) which is is includes documentation confirming that the pSite’s institutional requirements have been met and that local context information provided has been approved by the relying institution; this can be documented via a letter, email, memo,  etc.;

     4. pSite HRPP Clearance (via letter or email)

• Any other documents or information that the IRBO requests.

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• The protocol and consent document must be in clean Microsoft Word format. (However, if you are submitting a tracked pdf that the sponsor has provided for IRB submission, this may be included with tracked changes noted.)
• When submitting documents to the NIH electronic IRB system, each electronic regulatory file must have a consistent format, including naming of folders and files, to ensure required information is maintained and easily accessible.
• For proper nomenclature study teams are required to use when submitting documents to the NIH IRB. Refer , refer to the section of the OHSRP website which outlines required nomenclature for protocols, consent forms and other study documents titled How to Name Documents for Submission to the IRB. 

What is the process when changes to the protocol require approval by other committee(s) as part of a modification submission?

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• NIH IRBO is responsible for screening all submissions to determine whether the modification needs to be reviewed by the convened IRB or can be processed via expedited review.
• Once all documents relevant to the modification gets get submitted in the NIH electronic IRB system, the internal review process begins:

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