INSTRUCTIONS: Edit Submission

Intended For: Researchers

Purpose: Making additional edits to aninitial application, modification, continuing review report, or report of new information

Submissions may be edited before they are submitted to HSD, if the IRB requests clarifications or modifications to the submission, or if the submission is deferred. The Principal Investigator (PI), PI proxy, primary contact, and any member of the study team may edit the submission, but the PI or PI proxy must submit the changes.

It is recommended that you complete your edits to study documents such as the IRB Protocol Form or the consent form first.

WHEN UPDATING A PREVIOUSLY SUBMITTED DOCUMENT:

  • Microsoft Word Documentsshould be revised in tracked-changes format
  • If it is not possible to track changes due to the file format, include a summary of the changes in your response to HSD
  • When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version

The version of the study document that is currently in Zipline should be used when making revisions.

Edit Study Documents- Prior to Study Approval

  1. Locate the draft of the document that needs to be edited in the Documents tab
  1. Save the document to your computer for editing and turn on Track Changes

NOTE: See INSTRUCTIONS: Track Changes in Microsoft Word for detailed instructions.

  1. Close the document after edits are complete andfollow the Edit Submission steps to upload the revised study document

Edit Study Documents- After Study Approval

  1. In the Documents tab, open the Final version of the document to be edited

FOR CONSENT FORMS: Because the final version is a PDF, select the draft version in Word instead of the final version. In some cases, this document may contain tracked changes and comments that have been accepted in the final version. If so, use the review features in Word to accept all the changes and remove any comments, and use this clean document as a starting point for your revisions.

  1. Save the document to your computer for editing and make sure Track Changes is enabled

NOTE: See INSTRUCTIONS: Track Changes in Microsoft Word for detailed instructions.

  1. Close the document after edits are complete follow the Edit Submission steps to upload the revised study documents.

Edit Submission Steps

  1. Edit the fields in the SmartForms as needed, using the Jump To menu or the Continue button to progress through the forms

TO UPLOAD REVISED STUDY DOCUMENTS:

  1. Click Update by the revised document in the SmartForm. For example, to upload a revised consent form:
  1. Click Browse or Choose File (depending on your browser)

  1. Select the revised document from your computer and double click or click Open

  1. Add a document name and version number if desired and click OK

  1. The updated document will replace the older version

NOTE: Click Add if you are uploading a completely new document, and click Delete to remove a document from the study

NOTE: Older versions can be viewed by clicking History

  1. Click Save and Exit to leave the SmartForm and return to the submission workspace

Updated: May 4, 2017Version 1.3