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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


  • 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.
  • For NIH IRB Document Templates please navigate here.


Protocols


  • How to Name a Clean Protocol:

    • IRBNumber_ProtocolClean_VersionDate(YYYYMMDD)

  • Example of a Correctly Named Clean Protocol:

    • 18M0015_ProtocolClean_20210521

  • How to Name a Tracked Protocol:

    • IRBNumber_ProtocolTracked_VersionDate(YYYYMMDD)_Tracked

  • Example of a Correctly Named Tracked Protocol:

    • 18M0015_ProtocolTracked_20210521


Consents


If conducted at the Clinical Center and the NIEHS CRU

  • How to Name a Clean Consent

    • IRBNumber.OPSConsentNumber_Cohort_CleanConsent_VersionDate(YYYYMMDD)

  • Example of a correctly named Clean Consent

    • 18M0015.1_HealthyVolunteer_CleanConsent_20210521

    • 18M0015.2_Spanish_CleanConsent_20210521

  • How to Name a Tracked Consent:

    • IRBNumber.OPSConsentNumber_Cohort_TrackedConsent_VersionDate(YYYYMMDD)

  • Example of a correctly named Tracked Consent:

    • 18M0015.1_HealthyVolunteer_TrackedConsent_20210521

    • 18M0015.2_Spanish_TrackedConsent_20210521


If NOT conducted at the Clinical Center and the NIEHS CRU

  • How to Name a Clean Consent

    • IRBNumber_Cohort_CleanConsent_VersionDate(YYYYMMDD)

  • Example of a correctly named Clean Consent

    • 18M0015_HealthyVolunteer_CleanConsent_20210521

    • 18M0015_Spanish_CleanConsent_20210521

  • How to Name a Tracked Consent:

    • IRBNumber_Cohort_TrackedConsent_VersionDate(YYYYMMDD)

  • Example of a correctly named Tracked Consent:

    • 18M0015_HealthyVolunteer_TrackedConsent_20210521

    • 18M0015_Spanish_TrackedConsent_20210521

***Please Note: For Assents change the word “Consent” to “Assent” in the filename.***


Examples of Nomenclature for Other Study Documents


  • How to name a Study Personnel Page:
    • IRBNumber_StudyPersonnelPageClean_VersionDate(YYYYMMDD)
  • Examples of a correctly named Study Personnel Page:
    • 18M0015_StudyPersonnelPageClean_20210521
    • 18M0015_StudyPersonnelPageTracked_20210521


  • How to name an Investigator Brochure:
    • IRBNumber_Drug name_InvestigatorBrochureClean_Version #_VersionDate(YYYYMMDD)
  • Examples of a Correctly Named Investigator Brochure:
    • 18M0015__M7824_InvestigatorBrochureClean_v3_20210521
    • 18M0015_M7824_InvestigatorBrochureTracked_v3_20210521


  • How to name a Package Insert:
    • IRBNumber_Drug name_PackageInsertClean_VersionDate(YYYYMMDD)
  • Examples of a Correctly Named Package Insert:
    • 18M0015_Rituximab_PackageInsertClean_20210521
    • 18M0015_Rituximab_PackageInsertTracked_20210521
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