Download Protocol & Other Templates

  1. Log into the CATS IRB system (Penn State users only)
  2. Click on the “Library” from the left side menu
  3. Click on “Templates” in the middle menu bar (within the Library)
  4. Download and complete a protocol (HRP-591 Protocol for Human Subject Research is the most common, see the Investigator Manual in the "Help Center" for help choosing a template)
  5. Download and complete the HRP-509 Study Team Member Qualification Template, if necessary.  See the first page of the template for instructions on who must submit the form.  Other templates may be needed, but these will get you started.
  6. Review the Investigator Manual  (also available in the "Help Center") for assistance in filling out the protocol and answering policy questions 

Tips: Change # of items displayed to 100 at bottom right side of page. You must use templates provided.

Complete Online Study Submission Forms

  1. Click on “My Inbox” (top right corner of banner, if not already there)
  2. Click “Create New Study” button located on left side menu
    • System uses a “smartform”; additional screens may appear based on responses
    • Red asterisks indicate required questions
    • Blue question bubbles available for help
  3. Click “Continue” to complete each page and be sure to upload the necessary documents to appropriate pages
  4. Click “Save & Exit” button on the right side of screen to finish the smart form
  5. Select “Submit” button on left side menu (only a PI or PI Proxy can submit)

Tip: If you don’t have time to complete the online Study Submission Form, you can return to the form anytime (as long as the first page was saved) – return by clicking on study name in My Inbox

Questions? Check out the Investigator Manual and our Training Resoruces to address questions. 

Respond to Clarification Requests

  1. You may need to clarify content submitted to the IRB – if there are requests to do so, you will receive an email notification and can access the submission from My Inbox
  2. Review the information in the History tab located in the middle of the submission workspace and follow the instructions to respond

Avoid Review Delays

  • Protocol
    • Read the instructions on the protocol
    • Type your response where indicated
    • Type N/A for questions that do not apply to your research
  • Templates
    • You must use the templates provided in CATS IRB (there are multiple options; refer to the Investigator Manual in the Help Center to learn more)
    • Consent templates – add study-specific information where requested and delete information not applicable, as indicated
  • Online Study Submission Form
    • Upload the correct documents to the appropriate pages on the online Study Submission Form
  • Responding to Clarifications
    • Respond to questions from the IRB as soon as you can
    • Never delete documents that were already provided to the IRB unless you have been instructed to do so
    • Use the tracking feature in Microsoft Word to track changes on your protocol and/or on other documents, as requested and be sure to read all instructions on the request