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.

...

Anchor
remember remember

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 (s) (within the document itself and in the filename) with EACH response to stipulations.When responding to corrections, update the version of document within the document AND document filenameeach 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.

...

Anchor
protocol protocol

...

Protocol Nomenclature

• How to Name a Clean Protocol:

  • IRBNumber_ProtocolClean_VersionDate(DDMMMYYYY)

• Example of a Correctly Named Clean Protocol:

  • 18M0015_ProtocolClean_14JAN2021

• How to Name a Tracked Protocol:

• IRBNumber_ProtocolTracked_VersionDate(DDMMMYYYY)

• Example of a Correctly Named Tracked Protocol:

• 18M0015_ProtocolTracked_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

• How to Name a Tracked Consent:

IRBNumber.OPSConsentNumber_Cohort_TrackedConsent_VersionDate(DDMMMYYYY)

• Example of a correctly named Tracked Consent:

• • 18M0015.1_HealthyVolunteer_TrackedConsent_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

• How to Name a Tracked Consent:

• IRBNumber_Cohort_TrackedConsent_VersionDate(DDMMMYYYY)

• Example of a correctly named Tracked Consent:

18M0015_HealthyVolunteer_TrackedConsent
• • _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 

...

Anchor
otherstudy otherstudy

Examples of Nomenclature for Other Study Documents

...

• IRBNumber_StudyPersonnelPageClean_VersionDate(DDMMMYYYY)

...

• 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

...