Fred Hutch IRB asks researchers to transition studies to different statuses as the research progresses (e.g., Open to Accrual, Long-Term Follow-Up, Data Analysis Only, etc.).
To assure an accurate indication of your study status throughout the life of your research, please follow the guidance below when submitting a Modification or Continuing Review.
Note: A modification does not need to be submitted if the only change to report is a change to the study status. Instead, you can wait to report the change in status in your next Continuing Review.
Please contact IRO@fredhutch.org with questions about study status.
| Hutch IRB SmartForm: Study Status Options | Study Status Description |
|---|---|
| No participants have been enrolled at this location | Select this status if you have received IRB approval for your study, but absolutely no human subject research activity has occurred at the site. |
| Open to Accrual of New Participants / Open to the Collection of Specimens or Records | New participants may enroll. Active collection of data/specimens from new participants is occurring. |
| Accrual is temporarily on hold | An active and approved study open to accrual where the IRB, investigator and/or sponsor has declared a formal “hold” or halt to accrual to mitigate a pending matter (e.g., safety issues being assessed, pending amendment, pandemic, etc.). If this status is indicated, the hold can only be lifted by the IRB through either a study modification or at an upcoming Continuing Review for your study where you indicate a new status and provide documentation that the hold has been lifted. |
| Permanently closed to accrual – clinical interventions, surveys, or similar participant interactions continuing | No NEW participants will be enrolled on this research. No data/specimens from a NEW participant will be added to the study. Study activity is ongoing for currently enrolled participants and may include:
Collection of data/specimens from existing subjects |
| Permanently closed to accrual – remaining activity limited to collection of participant long-term follow-up data | Long-term follow-up must be limited to accessing clinical data from procedures participants would undergo as part of clinical care. If any follow-up procedures (scans, blood draws, questionnaires, etc.) are being done only for the research, or at a schedule different from standard care, this is not the right status. Research activities are limited to the following:
Analysis of existing specimens |
| Closed to Accrual – remaining activities limited to analysis of specimens/data already collected | The intent of this status is to indicate a “winding down” of all study activities to only include analysis of identified or de-identified data and/or specimens that were collected for research purposes for this study. This is the last phase prior to closing a study permanently. Research activities are limited to the following:
|