Completing the Study Closure or Transfer of Study Review Responsibility Worksheet
OVERVIEW
BEFORE YOU BEGIN
- Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager
- The Worksheet is completed in IRBManger by the Principal Investigator (PI) or PI’s designee.
- Confirm that all criteria are met for study closure or transfer listed in the Worksheet.
- 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
The PI or designee answers all questions on the Study Closure or Transfer of Study Review Responsibility Worksheet.
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.
COMPLETE THE STUDY-SPECIFIC INFORMATION QUESTIONS
- Question 2: The Signatory Institution auto-populates 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.
- Question 3: This field is used to identify the current PI of Record to this Worksheet. The email address entered should be the one associated with the PI in the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS).
COMPLETE THE STUDY CLOSURE OR TRANSFER OF STUDY IRB REVIEW RESPONSIBILITY
- Question 4: Indicate the action you want to perform for the study, either Study Closure or Transfer of Study IRB Review Responsibility from the CIRB to another IRB.
COMPLETE THE “STUDY CLOSURE” OPTION CHOSEN QUESTIONS
There are four parts to this section.
Please contact the Network sponsor to confirm that the study can be closed at the local site before submitting this worksheet.
- The first is a list of studies associated with the current PI.
- The second part is a single text box to enter the first study to be closed. Please note that the study listed in this section must match one of the studies listed above. 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.
- The third part is to confirm that the closure requirements have been met for the identified study.
- The study is closed to accrual at the Signatory Institution and all Component and/or Affiliate Institutions relying on the Signatory Institution for this study.
- All study participants have completed study intervention(s) and follow-up activities OR no study participants were enrolled.
- There will be no further research activity for this study (this includes recruitment, enrollment, data collection, data analysis, data submission, etc.).
- The fourth part is to attach a copy of the completed and approved Early Study Closure Confirmation form. The Early Study Closure Confirmation form is required for all studies, even those where no participants have been enrolled.
All closure requirements must be met for the study to be closed with NCI CIRB.
The second and third parts will repeat to allow up to 10 unique studies to be closed using a single Study Closure or Transfer of Study Review Responsibility Worksheet. If you are closing more than 10 studies, you will need to submit additional Study Closure or Transfer of Study Review Responsibility Worksheets.
OR
COMPLETE THE "TRANSFER OF STUDY IRB REVIEW RESPONSIBILITY FROM CIRB TO ANOTHER IRB" QUESTION
There are three parts to this section.
Please contact the Network sponsor to confirm that the study can be closed at the local site before submitting this worksheet.
- The first is a list of studies associated with the current PI.
- The second part is a single text box to enter the first study to be transferred. Please note that the study listed in this section must match one of the studies listed above. 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.
- The third part is to attach a copy of the full board IRB approval letter from the new IRB. This letter should indicate that the IRB accepts the study and approves continuation of research prior to the transfer to ensure there is no lapse in IRB oversight of the study.
The second and third parts will repeat to allow up to 10 unique studies to be transferred using a single Study Closure or Transfer of Study Review Responsibility Worksheet. If you are transferring more than 10 studies, you will need to submit additional Study Closure or Transfer of Study Review Responsibility Worksheets.