Submitting an Amendment

Create an Amendment

A list of available protocols will populate. Find the protocol that requires an amendment, select perform action next to the protocol number.

  1. Request an Action
    1. Create Amendment: Click ►show next to Create Amendment.
    2. Paper based protocols and KC Questionnaire Based Studies:
      1. Select any areas of the Protocol tab that require revising or the Personnel tab or Attachments tab.
    3. For KC Questionnaire Based Studies:
      1. Select any Questionnaires that require revising.
    4. Summary: Minimal information in this box is necessary (i.e. Amendment).
    5. Click create.
    6. Navigate to the Questionnaires Tab.

  1. Completing the Questionnaire:
    1. Answer the Amendment Questionnaire as applicable till green.
    2. For Questionnaire Based Studies:
      1. Questionnaires that have been selected for revising will appear below the amendment questionnaire in the “Amendable Questionnaire” section.
      2. If changes are needed to other areas of the KC Protocol, navigate to that tab. If that area is not open for editing go back to the protocol actions tab under “Modify Amendment Sections” and select the area which you need to revise.

Once all required information has been entered on Amendment Questionnaire and all changes have been made, navigate to the Notes & Attachments tab.

If you are revising any documents are adding/removing any documents.

  1. Navigate to the Notes & Attachments tab.
  2. Revised documents should be updated by using the replace function.
    1. Next to the document in the Notes & Attachments that you have revised click ►show.
    2. Click replace (located between view and delete).
    3. Click choose file to find the revised version to upload (do not forget to update your description if you put a file version).
    4. Click save.
  3. To remove an existing document simply click ►show next to the document and click delete.

Once all required information has been entered on all tabs and all changes have been made, click save and navigate to the Protocol Actions tab to submit the amendment.

Submit Amendment

When all Questionnaires are complete, and all Documents have been attached, and the item is ready for review, it must be submitted in the KC system via the Protocol Actions tab.

Expedited Studies

    1. Click ►show on the Request an Action panel.
    2. Click ►show next to Submit for Review.
      1. Categories will appear but you should not and do not need to select any additional categories.
    3. Click submit.

Full Board Studies

  1. Click ►show on the Request an Action Panel
  2. Click ►show next to Submit for Review.
  3. Click submit.

Human Subjects Research Questions:

Email: irb@iu.edu

Phone: (317) 274-8289

KC IRB Help:

Email: kcirb@iu.edu

Phone: (812) 856-4242