Naming your documents
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.
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
- Update the version date of the document(s) (within the document itself and the filename) with each new submission to the IRB.
- You do not have to update the version date with each response to clarifications or stipulations, retain the same version date throughout that one submission.
- 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.
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Protocol Nomenclature
- How to Name a Clean Protocol:
- IRBNumber_Protocol_Clean_VersionDate(DDMMMYYYY)
- Example of a Correctly Named Clean Protocol:
- IRB123456_Protocol_Clean_14JAN2025
Consent Nomenclature
Clean Consents
If your consent will be in CRIS:
- How to Name a Clean Consent
- IRBNumber.OPSConsentNumber_Cohort_Clean_Consent_VersionDate(DDMMMYYYY)
- Example of a correctly named Clean Consent
- IRB123456.1_Healthy_Volunteer_Clean_Consent_14JAN2025
If you are unsure about the OPS Consent Number, email the following address and ask for a numbered list of your consent documents: cc_protocol_services@cc.nih.gov
If your consent document will not be in CRIS:
- How to Name a Clean Consent
- IRBNumber_Cohort_Clean_Consent_VersionDate(DDMMMYYYY)
- Example of a correctly named Clean Consent
- IRB123456_Healthy_Volunteer_Clean_Consent_14JAN2025
***Please Note: For Assents change the word “Consent” to “Assent” in the filename. ***
Redacted Consents
Please put the Consent Version Date in the title and not the document signature date.
- How to Name a Redacted Consent
- IRBNumber_Cohort_Consent_VersionDate(DDMMMYYYY)_REDACTED
- Example of a correctly named Redacted Consent
- IRB123456_Healthy_Volunteer_14JAN2025_REDACTED
Translated Consents
Please put the Consent Version Date in the title and not the document signature date.
- How to Name a Translated Consent
- IRBNumber.OPSConsentNumber_Cohort_Consent_VersionDate(DDMMMYYYY)_LANGUAGE_TRANSLATED
- Example of a correctly named Translated Consent
- IRB123456.4_Healthy_Volunteer_14JAN2025_HINDI_TRANSLATED
Examples of Nomenclature for Other Study Documents
- How to name an Investigator Brochure:
- IRBNumber_Drug name_IB_Clean_Version #_VersionDate(DDMMMYYYY)
- Examples of a Correctly Named Investigator Brochure:
- IRB123456__M7824_IB_Clean_v3_14JAN2025
- IRB123456_M7824_IB_Tracked_v3_14JAN2025
- How to name a Package Insert:
- IRBNumber_Drug name_Package_Insert_Clean_VersionDate(DDMMMYYYY)
- Examples of a Correctly Named Package Insert:
- IRB123456_Rituximab_Package_Insert_Clean_14JAN2025
- IRB123456_Rituximab_Package_Insert_Tracked_14JAN2025