Completing the Continuing Review Application

The first section of the Contiuing Review Application is prepopulated by CIRB staff and is not open to edits. Review the information in these fields and click Next. If you notice an error, please contact the CIRB Operations Office using the emails listed above.

• Header section: OMB boilerplate language regarding the purpose of the application and estimated time to complete the application.
• Study ID: Prepopulated.
• Study Title: Prepopulated.
• Study PI: Prepopulated
• Event: Prepopulated.
• CIRB Expiration Date: Prepopulated.
• Protocol Version Date: Enter the protocol version date (PVD) of the most recently CIRB-approved protocol.
• Enter the email address for the main contact person for CIRB communication. This is typically the study coordinator.
• List the names and email addresses of all individuals (up to four people) who should also receive all CIRB outcome letters sent to the Study Chair.
• Question 1.0: What is the study’s current CIRB status? Select the appropriate status from the list. 
  What is the Initial Activation Date. Enter the Date of Initial Approval.
• Question 1.2: Multiphase Studies Summary of Study Progress. If this is a multiphase study, summarize progress so far, note the current phase, and give timelines for the next phase or expansion cohorts; enter N/A if not applicable.”

• Question 2.1: Accrual Target. Enter the target number of participants in the text box.
• Question 2.1.1: Number Enrolled. Enter how many participants have enrolled so far in the text box.
• Question 2.1.2: Currently on Study Treatment or Intervention. Enter how many participants are currently receiving the study treatment or intervention in the text box.
• Question 2.1.3: Completed Treatment. Enter how many participants have completed the study treatment or intervention in the text box.
• Question 2.1.4: In Follow-Up. Enter how many participants are no longer on treatment but are still in follow-up in the text box.
• Question 2.1.5: Withdrawn or Ended Treatment Early. Enter how many participants stopped treatment early or chose to withdraw in the text box.
  Reasons for Withdrawal/Termination. Briefly explain why participants withdrew or ended treatment early. Use the text box provided.
• Question 2.2: Projected Enrollment at Study Sites.
• Question 2.2.1:Protocol Reference. Give the section and page number in the protocol where the planned enrollment tables by race and ethnicity appear.
• Question 2.2.2: Zero Values in Enrollment. Select Yes/No if any race/ethnic categories show “0.”
  If Yes, briefly explain why.
• Question 2.3: Current Enrollment at Study Sites. Attach the Cumulative Inclusion Enrollment Report with race and ethnicity data in the text box. Use the Cumulative Inclusion Enrollment Report when completing this section.
• Question 2.4: Recruitment Progress (Overall). Indicate if study recruitment is on track with the planned schedule by selecting Yes or No. If Yes, give a short update on progress. If No, briefly describe the plan to address recruitment issues.
• Question 2.5: Recruitment Progress (Race and Ethnicity). Indicate if recruitment by race and ethnicity is on track with the planned schedule as described in the Cumulative Inclusion Enrollment Report by selecting Yes/No. 
  If Yes, provide a short update. 
  If No, describe the plan to improve recruitment in underrepresented categories.

Provide any new information since the last continuing review or initial review if this is the first Continuing Review submission.

• Question 3.1: Presentations or Publications. State if study findings were presented or published outside of the Data and Safety Monitoring Board. 
  If Yes, use the text box to explain and upload copies.
• Question 3.2: New Information on Risks or Benefits. Confirm if new publications or other information on risks, benefits, drugs, procedures, or alternative therapies about the study drug or intervention and/or disease condition being studied has become available. 
  If Yes, explain in the text box and attach documents.
• Question 3.3: Protocol or Document Changes. Indicate if there were any changes, amendments, or administrative updates to the protocol, consent form, or questionnaires. If Yes, list all updates with the corresponding protocol or update dates.
• Question 3.4: Investigator’s Brochure / Package Insert. Confirm if the Investigator’s Brochure or package insert has been updated.
  If Yes, enter the drug name and the current version date and upload accompanying documents.
• Question 3.5: Conflict of Interest. Indicate if the Study Chair or key study staff had changes in financial conflict of interest.
  If Yes, explain in the text box and answer 3.5.1.
• Question 3.5.1: Significant Conflicts. State if these updates led to new or revised significant financial conflicts under NCI/DCTD policy.
  If Yes, upload the coordinating group’s management plan.
  If No, explain why none is needed.

• Question 4.1: Safety Oversight. Select how study safety is monitored (DSMB, safety committee, other, or not applicable).Provide the most recent and next DSMB meeting dates. Attach the DSMB report if available.
  If no DSMB, describe when and how safety was last reviewed and the outcome.
• Question 4.1.1: Date of last DSMB or safety monitoring meeting.
  Attach the current DSMB report supplied to investigators.
• Question 4.1.2: Date/approximate date of the next DSMB or safety monitoring meeting.
• Question 4.1.3: If no DSMB is being utilized, state when and how the continued progress of the study was last monitored/reviewed and state results from that discussion.
• Question 4.2: Toxicity Summary. State if a toxicity summary report has been prepared. 
  If Yes, attach the report.
• Question 4.3: Study Summary Report. State if a study summary report has been prepared. 
  If Yes, attach the report.
• Question 4.4: Dose Limiting Toxicities (DLTs). Indicate if any DLTs occurred. 
  If Yes, explain whether they led to changes in accrual status.
• Question 4.5: Adverse Events (AEs). Confirm if any AEs have occurred. 
  If Yes, enter in the text boxes:
      - Number of participants with AEs
      - Number of Grade 3, 4, and 5 events
      - For each of the grades summarize where these occurred (cohort/dose level) and whether a Dose Limiting Toxicity (DLT) was involved. 
  Attach a table if available.
• Question 4.6: Greater Risk of Harm. Indicate if any incidents, complaints, or outcomes suggest higher risk to the participants than expected.
  If Yes, explain in the text box.
• Question 4.7: Unanticipated Problems. Confirm if any trial-wide unanticipated problems or serious and/or continuing noncompliance events have occurred.
  If Yes, indicate whether these were reported to the CIRB and attach all related documentation.
  Question 4.8: Change in Risk-Benefit. Indicate if anything has changed that affects the study’s risk-benefit balance. 
  If Yes, explain briefly.
   

Attach supporting materials when applicable (Select all that apply):
 

• Publications/presentations (3.1)
• Risk/benefit information (3.2)
• Updated Investigator’s Brochure (3.4)
• Conflict management plan (3.5.1)
• DSMB/safety monitoring report (4.1.1)
• Toxicity summary (4.2)
• Study summary report (4.3)
• Unanticipated problems documentation (4.7)

Upload any additional documents requested by CIRB.