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Study Documents and Consents FAQs


Uploading Informed Consent and HIPAA Documents – Word or PDF?

  • Consent and HIPAA initial documents and subsequent revisions must be submitted in MS Word format.
  • Documents submitted in MS Word format are compatible with the document comparison feature in iMedRIS. The document comparison feature allows direct comparisons between version revisions of the Consent or HIPAA.
  • However, PDF, and other document formats are not compatible with the document comparison feature used to view/compare different versions of the informed consent and HIPAA within iMedRIS.
  • Other document formats will not allow Consent or HIPAA version document comparisons within iMedRIS.

How to make changes to the consent document? 

  • To make changes to the consent document create a revision from the approved document.

Can I submit a translated version of the consent?

  • Yes, a translated version of the consent document may be submitted using a Modification form.
  • Consent and HIPAA initial documents and subsequent revisions must be submitted in MS Word format.
  • Documents submitted in MS Word format are compatible with the document comparison feature in iMedRIS. The document comparison feature allows direct comparisons between version revisions of the Consent or HIPAA. PDF format versions are NOT compatible with the comparison feature.

Uploading Study Documents – Word or PDF?

  • iMedRIS will accept study documents in MS Word, PDF and other study document formats.

IRB Approval Stamp?

  • IRB Approval is affixed and visible on IRB approved informed consent, HIPAA and selected study documents.
  • The IRB stamp will display the Dignity Health logo, IRB or Study #, Approval Date, and may include an Expiration Date.
  • Please leave appropriate page margins, 1.25” at the top/bottom of each page to accommodate the stamp.

How do I submit Continuing Reviews, Modifications, Adverse Event reports, protocol deviations or other post approval reports?

  • Go to the My Projects” tab and open your active study.
  • Under the Submissions tab and select the name of the form that is needed.
  • Select Add New Form tab to complete a new form.
  • Remember to SAVE your work frequently. Unsaved work is not retained and will be lost.

Can I delete a form or study application that is no longer needed?

  • Yes, you can delete an un-signed DRAFT form if the IRB has not started processing it yet.
  • You cannot delete a form or study document that has been submitted, reviewed or approved by the IRB.

If you don't find the answers you're searching for, please call the East Valley Regional IRB at 480.728.3582.