Retrieving Study Documents

Print or Retrieve Questionnaires, Approval Letter, or Protocol Summary

Navigate to the Protocol Actions tab

  1. To print Questionnaires:
    1. Click ►show on the Print panel
    2. Click ►show on the Questionnaires section. The system will default to select all Questionnaires in the list.  To print all Questionnaires, click print selected. To print specific Questionnaires, uncheck the Questionnaires you do not wish to print, then click print selected.
  2. To print the Approval Letter:
    1. Click ►show on the Summary & History panel.
    2. Click ►show on the History section: Find the submission and its associated approval action in the History.
    3. Click ►show on the Correspondence section under the approval action.
    4. Click ►View under Actions column to download the Approval Letter
  3. To print the signed Protocol Summary (for FDA and/or VA studies):
    1. Click ►show on the Submission Details section.
    2. Click ►show on the Review Attachments section.
    3. Select ►view under the Action column next to the Approval document to download the signed document. Note: the Description may say something like “Signed PSR.”

To Print/Retrieve Approved Documents, Including Watermarked Informed Consent

Navigate to the Notes & Attachments tab.

  1. Click ►show on the Protocol Attachments panel.
    1. Download All Documents: Download all documents at once into a zip file by clicking select all and then clicking download selected.
    2. Download Selected Documents: Use the checkboxes to select which files to download and then click download selected.
    3. Download Individual Documents: Click ►show next to the document you want to download. Then select view to download.

To Print/Retrieve Post Approval Submissions (Amendments, Renewals, and Reportable Events)

Navigate to the Protocol Actions tab.

  1. Click ►show on the Summary & History panel.
  2. Click ►show on the History section: Find the submission and its associated approval action in the History.
  3. Click ►show on the Notifications section under the approval action.
  4. Move your mouse to hover over the protocol number in the Message field. Click on the protocol link.
  5. Once you are in the submission, follow the instructions above to retrieve the documents you need.

Contact the IU Human Research Protection Program

Human Subjects Research Questions:

Email: irb@iu.edu

Phone: (317) 274-8289

KC IRB Help:

Email: kcirb@iu.edu

Phone: (812) 856-4242