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Document Naming Conventions for Submissions 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.
    • When responding to corrections, update the version of document. 



Protocols

  • How to Name Clean Protocols:
    • [IRB# Number]_Protocol_[Version Date in DAYMONTHYEAR]
  • Example of Clean Protocol:
    • 2EI0042_Protocol_14JAN2020


Nomenclature Template for Tracked Protocols:

  • [IRB# Number] Protocol [Version Date in DAYMONTHYEAR] Tracked
  • Examples of Tracked Protocol Nomenclature
    • 2EI0042 Protocol 14JAN2020 Tracked



Consents

Template for Clean Consents:

  • [IRB# Number].[OPS assigned footer (#)] [Cohort name] [Version Date in DAYMONTHYEAR]

  • Examples of Submission Nomenclature:

    • NIH Site Clean Consent Documents

      • NIHIRB#.OPSFOOTER# Standard DAYMONTHYEARVersionDate

      • 12EI0042.1 Standard 14JAN2020

      • 12EI0042.2 Healthy Volunteer 14JAN2020

Nomenclature Template for Tracked Consents:

  • [IRB# Number].[OPS assigned footer (#)] [Cohort name] [Version Date in DAYMONTHYEAR] Tracked

  • Examples of Tracked Consent Nomenclature:

    • NIH Site Tracked Consent Documents

      • NIHIRB#.OPSFOOTER# Standard DAYMONTHYEARVersionDate Tracked

      • 12EI0042.1 Standard 14JAN2020 Tracked

      • 12EI0042.2 Healthy Volunteer 14JAN2020 Tracked

Nomenclature for Non-NIH Site Clean Consents:

  • Non-NIH Site Consents

    • Duke_IRB#_StdCF_08JULY20

    • Duke_IRB#_HealthyCF_08JULY20

Nomenclature for Non-NIH Site Tracked Consents:

  • Non-NIH Site Consents

    • Duke_IRB#_StdCF_08JULY20

    • Duke_IRB#_HealthyCF_08JULY20


















Nomenclature Template for Other Study Documents:

    • Company_name_protocolmarked_08JULY20
    • Company_name_protocolclean_08JULY20
    • NIH_Appendix_IRB#_protocolmarked_08JULY20
    • NIH_Appendix_IRB#_protocolclean_08JULY20
    • NIH_IRB#_DEC_08JULY20
    • Package_Insert_title_08JULY20
    • IB_Insert_title_08JULY20
    • RSC_Approval_ 08JULY20
    • CRC_SRC_Approval _08JULY20
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