OVERVIEW
This Quickguide provides instructions for changing the PI on a study.
BEFORE YOU BEGIN
- Use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to confirm that the new PI is on your roster or to add the PI to your roster. For more information, go to Updating Your CIRB Person Roster using RUMS.
- The Annual Principal Investigator Worksheet for the new PI assuming responsibility for the study at your institution must be approved by the CIRB. For more information, go to Establishing a Principal Investigator.
- The Change of PI Worksheet should be completed by the new Principal Investigator (PI) or designee. The Worksheet must be submitted by the new PI.
- If you are an NCI Division of Cancer Prevention (DCP) Consortia or CP-CTNet site, go to Navigating The CIRB For NCI Division of Cancer Prevention Consortia Sites And Cancer Prevention Clinical Trial Network (CP-CTNet) Organizations for information on how processes vary for you.
INSTRUCTIONS
STEPS
OPEN THE CHANGE OF PI WORKSHEET
- This selection is only for changing the PI for one or more studies. If there are study-specific changes you will need to submit a separate Revised Study-Specific Worksheet for each affected study.
COMPLETE THE SIGNATORY INSTITUTION INFORMATION QUESTIONS
- 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.
- The Signatory Institution autopopulates if you are associated with a single Signatory Institution. If you are associated with more than one Signatory Institutions, you will need to select the appropriate Signatory Institution for this worksheet.
COMPLETE THE CHANGE OF PI QUESTIONS
- There are three parts to this section. The first asks for the email address of the current PI associated with this Worksheet, the second asks for the email address of the PI assuming responsibility for this study, and the third asks if the new PI has submitted a PI Worksheet. The new PI assuming responsibility for this study needs to have an approved PI Worksheet before the Change of PI Worksheet can be submitted. The email addresses entered to identify the current and the new PI must be the ones associated with the PIs in RUMS.
STUDIES FOR CHANGE OF PI QUESTIONS
- There are four parts to this section. The first is a list of studies associated with the current PI and the second is a list of the studies associated with the new PI.
- The third part is a text box to enter the study or studies that should have the current PI changed to the new PI. Please note that each study listed in this section must have the same current PI and the same new PI assuming responsibility. Enter the complete study ID number. For example, you must enter NRG-GY004 and not GY004. Only the study number should be listed. The name of the Signatory Institution or study title should not be included in the list. Each study number should be listed on its own line. This worksheet is restricted to 50 studies. If you are changing the PI on more the 50 studies, you will need to submit additional Change of PI Worksheets.
- The fourth part is a check box to confirm that Change of PI Worksheet is used to change the PI for the identified studies and that any study-specific changes will be made by submitting an individual Revised Study-Specific Worksheet.