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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 (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.
• For NIH IRB Document Templates please navigate here.

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protocol protocol

Protocols

• How to Name a Clean Protocol:

• IRBNumber_ProtocolClean_VersionDate(DDMMMYYYY)

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• Example of a Correctly Named Tracked Protocol:

• 18M0015_ProtocolTracked_14JAN2021

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Consent Nomenclature

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

Clean and Tracked Consents

If conducted at the Clinical Center and the NIEHS CRU

• How to Name a Clean Consent

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• • 18M0015.1_HealthyVolunteer_TrackedConsent_14JAN2021

If NOT conducted at the Clinical Center and the NIEHS CRU

• How to Name a Clean Consent

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***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. 

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• • 18M0015_HealthyVolunteer_14JAN2021_REDACTED

Translated Consents

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

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otherstudy otherstudy

Examples of Nomenclature for Other Study Documents

• How to name a Study Personnel Page:
• IRBNumber_StudyPersonnelPageClean_VersionDate(DDMMMYYYY)
• Examples of a correctly named Study Personnel Page:
• 18M0015_StudyPersonnelPageClean_14JAN2021
• 18M0015_StudyPersonnelPageTracked_14JAN2021

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