KC IRB Renewal with Amendment

Create a Renewal

  1. Request an Action
    1. Create Renewal with Amendment: Click ►show next to Create Renewal with Amendment. All Renewals require an amendment at this time, if your study does not require changes, just select the Add/Modify Attachments and Notes box and IRB staff will make the adjustment later. DO NOT UNSELECT BOXES. Submitting a Renewal without a box checked will cause an error in the system.
    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. Renewal for year 20XX).
    5. Click create.

Navigate to the Questionnaires tab.

  1. Renewal Questionnaire:
    1. Complete Question ID #350 – 411 (as applicable)
    2. Click update.
  2. Changes and Amendment Questionnaire:
    1. Read the options carefully and select the answer that best fits your submission.
      1. If revisions are necessary complete the amendment questionnaire and see instructions on submitting an amendment.

Navigate to the Notes & Attachments tab.

  1. Uploading the DSMB Report:
    1. Click ►show next to Protocol Attachments.
    2. Click choose file next to File Name.
    3. Select the DSMB Report file.
    4. Description Box: Provide a brief description (i.e. DSMB Report).
    5. Attachment Type: From the dropdown select monitoring report/ae summary.
    6. Click add to upload the file, then save.

Once all required information has been entered on the Renewal Questionnaire and any necessary revisions have been made, click save and navigate to the Protocol Actions tab to submit for review.

Submit Renewal

When 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.

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