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.

• Things to Remember
• Protocol Nomenclature
• Consent Nomenclature
• Assent Nomenclature

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

Nomenclature Template for Clean Protocols:

• [IRB# Number] Protocol [Version Date in DAYMONTHYEAR]
• Examples of Clean Protocol Nomenclature
  • 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