Guidance on Requirements for Naming Study Documents: Use these helpful tips when working with the upgraded eIRB.
Draft and final versions of study documents can be accessed under the study’s Documents tab in the upgraded eIRB. Documents will not be divided into separate buckets by category (protocol, recruitment, consent, etc.) as they are in the current version of the eIRB. The category will be identified in the upgraded version, but the list of documents cannot be sorted. Thus, it is important to use names that make documents readily identifiable and easy to track if they are revised during the course of the study. IRB staff may return a submission with changes requested if document names do not conform to the following guidance.
As used in this article, the term “document name” refers to the name given to a study document when it is attached to an IRQ in the eIRB system. The term “file name” refers to the name given to a document when it is saved to a computer or network drive. “You” refers to a project manager or other member of the study team.
This pop-up appears when you attach a document to the IRQ:
Please use the Name field (#2 above) to name the document as you want it to appear in the IRB approval letter. You may enter a descriptive name for the document, or you may use the file name. The system will default to the file name if the field is left blank. The file name* must conform to the following guidance if you want to use it as the document name in the eIRB.
The beginning of the name should identify the type of document, e.g., protocol, consent, recruitment.
Add specific information to distinguish this document from other documents of the same type, for instance, when a study has multiple consent or recruitment documents. This part of the name should not be changed when the document is revised. Version numbers and dates are not required for IRB purposes. They should be entered at the end of the document name if you want them included in the approval letter.
Field #3 (Version number) in the pop-up shown above is optional. The eIRB will automatically assign an internal version number the first time a document is uploaded. The eIRB version number will be updated each time the document is revised to track version history within the system. You may use this field if needed for your reference. Please remember that version number and date must be entered at the end of the document name in field #2 if you want this information to be included in the approval letter.
Use abbreviations and acronyms with discretion. Remember that IRB members and staff are not as familiar as your study team with terminology specific to a particular study. Common abbreviations such as ”ppt” for participant, “QOL” for quality of life, and “IB” for Investigator Brochure are OK. As always, if in doubt, ask an IRB coordinator. Your submission may be returned with changes requested if IRB coordinators do not recognize an acronym or abbreviation used in a document name.
Study title: Coffee and Productivity (CAPS)
Study sponsor: Maxwell House
- Protocol – Main Study
- Protocol – Maxwell House MH12345 Amend3 4/1/2016. “Maxwell House MH12345” would be entered as part of the name if you want it to appear in the approval letter because the sponsor requires it or for other reasons. “Protocol Maxwell House MH12345” should not be changed when the document is revised. “Amend3” and “4/1/2016” are optional. It is fine to include this information if the sponsor wants it in the approval letter. Amendment/version numbers and dates can be updated as appropriate when the document is revised.
- Consent – Main
- Consent – CAPS MH12345 main v.3 4/1/2016. “Consent – CAPS MH12345 main” would be used if the study has more than one consent document and you want “CAPS MH12345” to appear in the approval letter. It should not be changed when the document is revised. “v3 4/1/2016” can be updated as appropriate when the document is revised.
- Consent – Pharmacogentic genetic sub-study v.1 12/25/2015
- Consent script – clinician interview
- Recruitment – brochure
- Recruitment script – clinician
- Survey – CAPS QOL 666
- Investigator Brochure MHS12345 Ed 2, 11/11/2015
The upgraded eIRB will produce a final version of all approved documents. All tracked changes will be accepted and comments removed in the final version. Beware! Document names must have more than three characters for the final version to be named properly. For instance, a Privacy Rule Authorization draft named “PRA” will be named “.pdf” in the final version listed under the Documents tab. This is an unfortunate quirk of the eIRB system. Your documents list in the eIRB will look something like this:
*A reminder about file names. It is best to keep file names short. File names should never contain spaces or special characters. This will ensure consistency and enable accurate backup and retrieval of data.
You can save a document to a descriptive file name using hyphens and underscores to avoid spaces in the file name:
- Privacy_Rule_Auth_4_1_2016.docx or Privacy_Rule_Auth_4-1-2016.docx or PrivacyRuleAuth.docx