How to Name Documents for Submission to the IRB

The page outlines the nomenclature study teams are required to use when submitting documents to the NIH IRB.  Each electronic regulatory file must have a consistent format, including naming of folders and files, to ensure required information is maintained and easily accessible.  Per the International Council for Harmonisation Good Clinical Practice Guidelines, essential documents allow for evaluation of the conduct of the study and quality of the study data.  

• Things to Remember
• Protocol Nomenclature
• Consent Nomenclature
• Assent Nomenclature
• Other Study Documents

Things to Remember

• Update the version date of the document each time you submit the document to the IRB.
• Update the Version Date of the document (within the document and in the filename) with EACH response to stipulations.
• When responding to corrections, update the version of document within the document AND document filename.
• If the IRB returns a document with stipulations and they have changed the filename of the document, remove the words "IRB Edits" or "Pre-review Edits" from the document title before you resubmit.