Working with Consent and Authorization Documents in New IRB Applications

Working with Consent and Authorization Documents in New IRB Applications

How do study teams provide consent and authorization documents in ARROW?

Consent and authorization documents are provided to the IRB by uploading them in the new initial review application.

How are documents uploaded in ARROW?

Documents are uploaded in ARROW using the "Add" button that appears after questions that request study teams to provide documents.

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Clicking on the "Add" button opens a window in your internet browser that allows you to search for and add files from your computer.

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Can a study team remove documents that were uploaded in error?

Yes. To delete a file, check the box next to the file name and then click the Delete button. This will delete that specific file from the application.

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How should study teams title uploaded files of consent and authorization documents?

When study teams upload a document to ARROW, they MUST provide a title for that document. This is important because the title provided will be the one displayed in the study’s Documents tab after the study is approved. If a title is not provided by the study team, ARROW will display the name of the file for the uploaded document. As file names are often abbreviated or truncated, providing a clear title for uploaded documents will help avoid confusion.

What are some examples of recommended titles for consent and authorization forms?

Examples of title formats for uploaded consent documents include (but are not limited to) the following:

  • Main Study Consent
  • Genetic Sub Study Consent
  • Study Assent Ages 7-14

Examples of title formats for uploaded authorization document include (but are not limited to) the following:

  • Main study authorization
  • Sub study tissue authorization.doc
  • Authorization (For studies with a single authorization form)

Do study teams need to include version numbers in the file names or document titles?

No. ARROW will automatically create a version number for each consent and authorization document. This version number does NOT need to be displayed in the title or file name for these documents.

Do study teams need to include the version number in the actual documents?

When possible, the IRB recommends that study teams include the ARROW version number in the actual documents for ease of tracking.

Tips on Consent and Authorization Documents

  • Be sure to clearly title each document that is uploaded to ARROW.
  • Use the Add button ONLY to add new documents to ARROW.
  • Use the Delete button ONLY to remove existing documents from ARROW.

See Also:




Keywords:upload, docs   Doc ID:17338
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-16 18:00 CSTUpdated:2016-08-03 13:09 CST
Sites:Health Sciences IRBs
Feedback:  1   1