Versioning Study Documents

August 1, 2011

This FAQ provides guidance for study teams on the versioning of documents uploaded to ARROW as part of the IRB application.

What documents are required to have a version?

Documents that will be used by a study team in the conduct of a study must have a version, whether provided by the sponsor or the study team. Such documents include, but are not limited to, the following: study protocol, consent and assent documents (including information sheets), authorization forms, data collection forms, recruitment materials, phone screening scripts, and questionnaires and similar survey tools.

Do documents provided by a sponsor or cooperative group need a version?

Study documents provided by a sponsor or cooperative group do need to be versioned. If the documents already include a version date and/or number, the UW study team does NOT need to provide any additional versioning. If a document provided by by a sponsor or cooperative group does not include a version date and/or number, the study team will be asked to add a version date as described below.

What type of versioning should be used?

Study documents must include a version based on date only. No version number should be included unless required by a sponsor or other entity. Examples of version dates include:

Version: 9/1/2011

Version: September 1, 2011

Where should the version date be located?

The version date can be located anywhere in the document except for the lower right-hand corner (which is where ARROW stamps certain documents). If the document has multiple pages, the version date should be included on each page.

When does the version date need to be updated?

A document’s version date should only be updated when a change is made to that document. Version dates do NOT need to be updated at continuing review.

What if a document is only available in a format that cannot be edited by the study team?

Study teams will not be required to provide a version date for a document that is only available in a format that cannot be edited (e.g., locked PDF files such as those for standardized surveys or sponsor-provided recruitment materials).

Keywords:version versioning study documents date protocol flyers sponsor forms consent assent information sheets data collection forms recruitment phone screening, scripts, consent version   Doc ID:19060
Owner:Carol P.Group:Health Sciences IRBs
Created:2011-07-06 19:00 CDTUpdated:2015-03-25 15:02 CDT
Sites:Health Sciences IRBs
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