Completing the Study Specific Worksheet
OVERVIEW
This Quickguide provides instructions for completing the Study-Specific Worksheet.
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 should be completed by the Principal Investigator (PI) or designee. The Worksheet must be submitted by the 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
The PI or designee should answer all questions on the Study-Specific Worksheet found in IRBManager.
INDICATE THE REASON FOR SUBMISSION
- The first time you complete the Worksheet, check the box indicating that this is a first submission. Indicate ‘revised submission’ in subsequent Worksheets submitted after initial approval.
- 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 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.
- Enter the complete study ID number. For example, you must enter NRG-GY004 and not just GY004.
COMPLETE THE GENERAL INFORMATION QUESTIONS
- Question 1: This field indicates the PI associated with this Worksheet. The email address entered must be the one associated with the PI in RUMS.
- Questions 2-12: For each question, a set of questions from the Annual Principal Investigator Worksheet is referenced. Indicate if there are any changes from the answers previously provided specific to this study. If there are changes, select Changed and describe what is changed.
COMPLETE THE ADDITIONAL STUDY-SPECIFIC MATERIALS FOR REVIEW QUESTIONS
- Question 13: Provide any study-specific recruitment materials as an attachment to this question.
- Question 14: Provide a study-specific assent form or consent at age of majority form as an attachment to this question.
- Question 15: Provide any translated documents specific to this study. The English document corresponding to the translated document, the translated version of the English document, and a translator’s certificate of accuracy must be attached for each translation requiring approval.