Reference Materials for Document Management

Tip sheet For Document Management in PROTECT 5.22.23

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.

*Please put the Consent Version Date in the title and not the document signature date.

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.
• No Longer 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.
• For NIH IRB Document Templates please navigate here.

Protocol Nomenclature

• How to Name a Clean Protocol:

  • IRBNumber_ProtocolClean_VersionDate(DDMMMYYYY)

• Example of a Correctly Named Clean Protocol:

  • 18M0015_ProtocolClean_14JAN2021

Consent Nomenclature

(Clean Consents, Tracked Consents, Translated Consents, and Redacted Consents)

Clean Consents

If conducted at the Clinical Center and the NIEHS CRU

• How to Name a Clean Consent

  • IRBNumber.OPSConsentNumber_Cohort_CleanConsent_VersionDate(DDMMMYYYY)

• Example of a correctly named Clean Consent

  • 18M0015.1_HealthyVolunteer_CleanConsent_14JAN2021

If NOT conducted at the Clinical Center and the NIEHS CRU

• How to Name a Clean Consent

  • IRBNumber_Cohort_CleanConsent_VersionDate(DDMMMYYYY)

• Example of a correctly named Clean Consent

  • 18M0015_HealthyVolunteer_CleanConsent_14JAN2021

***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_ConsentVersionDate(DDMMMYYYY)_REDACTED

• Example of a correctly named Redacted Consent

  • 18M0015_HealthyVolunteer_14JAN2021_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_ConsentVersionDate(DDMMMYYYY)_LANGUAGE_TRANSLATED

• Example of a correctly named Translated Consent

  • 18M0015.4_HealthyVolunteer_14JAN2021_HINDI_TRANSLATED 

Examples of Nomenclature for Other Study Documents

• How to name an Investigator Brochure:
  • IRBNumber_Drug name_InvestigatorBrochureClean_Version #_VersionDate(DDMMMYYYY)
• Examples of a Correctly Named Investigator Brochure:
  • 18M0015__M7824_InvestigatorBrochureClean_v3_14JAN2021
  • 18M0015_M7824_InvestigatorBrochureTracked_v3_14JAN2021

• How to name a Package Insert:
  • IRBNumber_Drug name_PackageInsertClean_VersionDate(DDMMMYYYY)
• Examples of a Correctly Named Package Insert:
  • 18M0015_Rituximab_PackageInsertClean_14JAN2021
  • 18M0015_Rituximab_PackageInsertTracked_14JAN2021