KC IRB Request to Close Protocol

Quick Guide: Request to Close an IRB Protocol

Applies to:  All research studies

Learn How To Access Your Protocol

Submit a Request to Close

  1. From the Protocol Actions tab, under the Request an Action panel, click ►show for the Request to Close section.
  2. Click ►show for the Closeout Report section.
  3. Complete the questions as they appear. Click update to save your work.
  4. Important: The last step you should take before submitting your Request to Close is to attach any required documents, e.g. DSMB report, deviation report, etc., to the Attachments section above the Closeout Report section.
    • In the Attachments section, click [Browse] to find the document.
    • Click add.
  5. To submit the report, click submit.

Respond to Screener Comments

If you receive a notification from KC (or directly from the HSO) requesting additional information or revisions, follow these instructions to respond:

  1. Access and Address Screener Comments and Attachments
    1. Click ►show on the Summary and History panel.
    2. Click ►show on the Submission Details section.
    3. Click ►show on the Review Comments section.
      1. Any general comments or comments related to parts of the KC IRB Protocol can be found here.
    4. Click ►show on the Review Attachments section:
      1. Click view in the Action column associated with the Closeout Report Questionnaire PDF document.
      2. Ensure you are opening the PDF in a full version of Adobe Acrobat, e.g. not a Reader version.
      3. Click on Comments to display the HSO screener comments; OR
      4. Position your mouse over the yellow highlighted text, right click, and Open Pop-up Note to view the HSO screener comments.
  2. Revise the Closeout Report Questionnaire in KC IRB
    1. From the Protocol Actions tab, under the Request an Action panel, click show for the Request to Close section.
    2. Click show for the Closeout Report section.
    3. Navigate to specific question ID(s) and make necessary revisions. Click update to save your work.
    4. Important: If you need to attach a document(s) with your response, that should be the last step you take before re-submitting your Closeout Report.
      1. In the Attachments section, click [Browse] to find the document.
      2. Click add.
    5. To re-submit the report, click submit.

Contact the IU Human Research Protection Program

Human Subjects Research Questions:

Email: irb@iu.edu

Phone: (317) 274-8289

QIO – Human Subjects Research Auditing Questions:

Email: researchcompliance@iu.edu

Phone: (317) 278-3458

KC IRB Help:

Email: kcirb@iu.edu

Phone: (812) 845-4242