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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 Report. Please contact with questions about study status.


Initial Approval with Minor Modifications

Study was reviewed by the IRB and approved with minor modifications necessary to secure final approval; however, for some reason (e.g., pending contract, FDA follow-up missing, etc.), the investigator has not been able to resolve the minor modifications yet. Use this status if needing to submit a Modification (or rare occasions cite on your Continuing Review Report) before the IRB has released approval documents.

Research Not Yet Started at This Location

An IRB-approved study, open to accrual, but where the investigator has not yet been able to start research locally pending a non-IRB related matter (e.g., logistics, site initiation issues, pending sponsor action, etc.). Use this status when you have received IRB approval documents, 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. You may bring in data/specimens from new participants.

Closed to Accrual – accrual 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 on a form that receives IRB approval, 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.

Closed to Accrual – clinical interventions, surveys, or similar participant interactions continuing

Study activity is ongoing and may include:

  • Intervention or interaction with existing participants
  • Continued use of a study drug or study device
  • Research-only follow-up procedures such as scans, blood draws, biopsies, questionnaires, etc.
  • Collection of data/specimens from existing subjects

Before changing to this status, please confirm that:

  • No NEW participants will be enrolled on this research.
  • No data/specimens from a NEW participant will be added to the study.

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.

Before changing to this status, please confirm that ongoing research activities are limited to the following:

  • Access of clinical data from participants’ regular medical records
  • Verification of survival status either through contact with the participant or a review of the National Death Index
  • Sending participant-level data or overall study results to participants as approved in the IRB application
  • 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.

Before changing to this status, please confirm that ongoing research activities are limited to the following:

  • Analysis of existing data or existing specimens. There is no plan to bring any additional data or specimens into the study.
  • Manuscript activities.

Closed – Final CRR – all research activities and data analysis are complete, requesting Closure of IRB File at this time

Termination or closure means that all study activity has ceased – whether because the sponsor has decided it may not continue, the investigator chooses not to continue the research, or the study activity and data analysis, including any manuscript preparation, are complete.

Before requesting closure, please verify the following:

  • Consent forms that have signatures are safely stored away from study data.
  • Data/specimens will not be retained for future use, even if de-identified. You must discard or destroy all data/specimens or move them into a separate repository file via a Modification.
  • The study will not be amended or re-opened for enrollment or for new data/specimens.