Completing The Notification of Incarcerated Participant Worksheet

Completing The Notification of Incarcerated Participant Worksheet

OVERVIEW

This Quickguide provides instructions for completing the Notification of Incarcerated Participant Worksheet.

BEFORE YOU BEGIN

  • You’ll need an active Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) account to access RUMS on the CTSU website and you must have an assigned role on the CIRB roster for your Signatory Institution to view the CIRB roster in RUMS. For more information, go to Individual Roles within the CIRB. If you are a Consortia site, go to Navigating the CIRB as a Consortia Site for information on how processes vary for you.

INSTRUCTIONS

The investigator or designee answers all questions on the Notification of Incarcerated Participant Worksheet.

Steps

COMPLETE THE SIGNATORY INSTITUTION INFORMATION QUESTIONS

  • Question 1: The submitting user information is auto-populated. Use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to change the auto-populated information relating to the person submitting and the name of the institution. For more information, go to Updating Your CIRB Person Roster Using RUMS.  
  • Question 2: Enter the complete study ID number.  For example, you must enter NRG-GY004 and not just GY004.
  • Questions 3: Enter the name and email address of the PI of Record for the study submitting the notification.
  • Question 4: Select the institution associated with this submission. In most cases, only one is available in the dropdown selection.  If the submitter of the Worksheet is associated with more than one institution, be sure to select the one associated with this submission.
  • Question 5: Enter the study ID or unique anonymous identifier for the specific participant. There should be a separated worksheet for each participant and study impacted.  
  • Question 6: Enter the date the participant was initially enrolled and the study arm, if any.
  • Question 7: Enter the date the participant was incarcerated.
  • Question 8: Enter how and when the PI was notified of the participant's incarceration.
  • Question 9: Enter the anticipated length of the participant's incarceration.
  • Question 10: Select the participant's type of incarceration.
  • Question 11: Select and explain why remaining on study is in the best interest of the participant
  • Question 12: Select and explain iIf the participant's status as a prisoner affectes the risks or benefits of participation
  • Question 13: Select and explain if there are risks to discontinuation on the study
  • Question 14: Select and explain if study visits and/or treatment could be potentially missed while incarcerated and how these will be handled
  • Question 15: Select and explain how study visists and/or treatment will be handled
  • Question 16: Select and explain If there is a need for follow-up examination or care of participants after participation and how this will be accomplished.
  • Question 17: Attach any other supporting document you feel the CIRB would need to complete the review.

If you feel you have questions completing this Worksheet, contact the CIRB Helpdesk.

 

Posted: 8/30/2019