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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.

Protocols

How to Name a Clean Protocol:
- IRBNumber_Protocol_VersionDate(MonthDayFullYear)_Clean

Example of a Correctly Named Clean Protocol:
- 18M0015_Protocol_12112020_Clean

How to Name a Tracked Protocol:
- IRBNumber_Protocol_VersionDate(MonthDayFullYear)_Tracked

Example of a Correctly Named Tracked Protocol:
- 18M0015_Protocol_12112020_Tracked

Consents

How to Name a Clean Consent:
- IRBNumber_Consent_Cohort_VersionDate(MonthDayFullYear)_Clean

Example of Correctly Named Clean Consent:
- 18M0015_Consent_HealthyVolunteer_12112020_Clean
- 18M0015_Consent_Spanish_12112020_Clean

How to Name a Tracked Consent:
- IRBNumber_VersionDate(MonthDayFullYear)_Tracked

Example of a Correctly Named Tracked Consent:
- 18M0015_Consent_HealthyVolunteer_12112020_Tracked
- 18M0015_Consent_Spanish_12112020_Tracked

Assents

How to Name a Clean Assent:
- IRBNumber_Assent_Cohort_VersionDate(MonthDayFullYear)_Clean

Example of Correctly Named Clean Consent:
- 18M0015_Assent_HealthyChild_12112020_Clean

How to Name a Tracked Consent:
- IRBNumber_VersionDate(MonthDayFullYear)_Tracked

Example of a Correctly Named Tracked Consent:
- 18M0015_Assent_HealthyChild_12112020_Tracked

Nomenclature for Other Study Documents:

- Example of a Correctly Named Key Study Personnel List/KSP List
  - 18M0015_KeyStudyPersonnel_12112020_Clean
  - 18M0015_KeyStudyPersonnel_12112020_Tracked