Continuing Review/Final Report/Reportable New Information FAQ

Continuing Review and Final Report

How will I know if and/or when it is time for a progress report?

Studies that are required to be reviewed at least once a year will receive a study expiration date. For projects that are greater than minimal risk (full board submissions), a complete and accurate progress or final report is due by the end of business on the first working day of the month prior to the month in which IRB approval ends. For example, if a study’s approval ends on June 15, a progress or final report is due the end of business on the first working day in June. Minimal risk projects with an expiration date are required to provide a progress or final report at least 4 weeks prior to expiration.

IRBNet sends principal investigators (PIs) courtesy reminders when a continuing review submission is due. Reminders are sent 60, and 30 days prior to study approval expiration.

Please note that if you wait until you receive the 30-day reminder to submit your continuing review materials, you will miss the submission deadline. It is the PI’s responsibility to ensure that a progress report to reapply for approval is submitted to the IRB by the submission deadline.

Where do I find the Continuing Review form?

Go to the study's project overview within the IRBNet system. Select Create New Package under Project Administration. On the Designer page, click Start New Wizard and select the option for Continuing Review/Closure Form. You can submit a continuing review and a modification at the same time by also creating a modification wizard (select continuing review as submission type for this type of submission).

What happens when my study's IRB approval has lapsed?

The IRBNet sends out reminder notices at 60, and 30 days prior to when a study’s IRB approval will lapse.

If IRB approval lapses, no study activity can continue except to protect the safety of participants. The PI must report to the IRB immediately if study activity needs to continue for participant safety to discuss the appropriateness of this plan.

The KPNW IRB has the discretion to not review any new studies for PIs or co-PIs who have lapsed studies until all delinquent reviews are completed.

If the PI is a CHR investigator, notification of any IRB approval lapse will be sent to the PI's supervisor, the Science Administration Director, and the Manager of Research Compliance.

The IRB may determine that continuing noncompliance has occurred after receiving additional evidence or reports of multiple instances of the same  noncompliance, including repeated study expirations or failure to respond to the IRB’s requests.

When Can I Submit a Final Report to Close My Study?

A final report may be submitted when ALL of the following criteria have been met:

  1. Enrollment is closed,
  2. Participants have completed all research-related interventions,
  3. Data collection is complete, and
  4. Data analysis of identifiable private information described in the IRB-approved research plan has been completed.

Sometimes people worry they will get questions after a publication that will make them want to go back to look at the data again and therefore they are hesitant to close the study. It is acceptable to look at the raw data after the study has closed IF you just want to answer a question, but you can’t do any additional analysis on that data. However, if you de-identify the data first you can do additional analysis on that de-identified data. De-identified means that the identity of the subject is or may not readily be ascertained by the investigator or associated with the information.

For multi-site studies: If you have completed data collection and analysis at this site and have no other responsibility in the trial, the study may be closed at this site even if it is continuing elsewhere. Please note that if you are the prime awardee for the study you must keep it open until all four criteria above are met at all sites.

How do I submit a final report to close a study?

Go to the study's project overview within the IRBNet system. Select Create New Package under Project Administration. On the Designer page, click Start New Wizard and select the option for Continuing Review/Closure Form. Once in the wizard, select the option for study closure.

Relevant Standard Operating Procedure

SOP KP-002: Continuing Review of IRB-Approved Research

What if I have a question about continuing review that is not covered in the FAQs?

You may contact RSPO if you have any questions about completing a progress or final report.

Reportable New Information

How do I report a protocol violation or breach of confidentiality?

You can report any protocol violation or breach of confidentiality via the IRBNet Reportable New Information form located on the forms and templates page. Protocol violations must also be reported at the time of continuing review.

How do I report protocol deviations and protocol exemptions?

Protocol deviations and exemptions can be reported at time of continuing review.

What happens if a serious adverse event occurs in my study?

All serious, unanticipated, and study-related adverse events affecting participants in a KPNW study must be reported per SOP KP-502 to the IRB via the Reportable New Information form located on the forms and templates page.

The PI is responsible for reviewing serious adverse events, indicating whether an event was causally related to the study and whether a revision of the consent form is recommended.

All other serious adverse events on FDA-regulated trials that meet the reporting criteria must be reported in summary at the time of the study’s continuing review.

How do I develop a corrective and preventive action plan (CAPA)?

For guidance about CAPAs, see Thinking About a Corrective Action Plan.

Standard Operating Procedures Relevant to Reportable Events