science

Continuing Review Tips & Reminders

  • Don’t wait for notices! As a general rule submit your continuing review two months prior to your study’s expiration date. Use your initial or continuing review approval letter to track your anniversary date (Microsoft Outlook reminders may be useful for this). Remember, your anniversary date will not change anymore!
  • Please refer to the Create a Continuing Review for an Active Study Tip Sheet to guide you through the continuing review submission process.
  • Always submit your continuing review as a “Modification and Continuing Review” (MODCR), regardless if there are any changes included with the submission. You can simply state that no changes are being made in the “Summarize the Modifications” section of the submission.
  • For guidance on where study-related documents should be uploaded in eIRB, please refer to Documents and Forms to upload to eIRB.
  • If IRB approval for your study does expire, you are no longer approved to conduct any research activity on your study. If you do have to conduct research due to a subject safety issue for example, then let the IRB know. Also, try to submit your continuing review as soon as possible.
  • Don’t over-enroll! Just ask for an increase in enrollment at continuing review (MODCR) or as a modification (MOD) at any time during the study.
  • Only validated ICFs should be used to consent subjects (these are the ICFs with the IRB validation dates).
  • Ensure all applicable supporting documentation for all studies that are still enrolling subjects is included with the submission.
  • However, if your study has closed subject enrollment, ICFs, recruitment material, and any intervention material or Drug and Device documentation that are no longer being used does not need to be submitted. Studies closed to enrollment, conducting data analysis need only conduct the abbreviated process described above.
  • Always submit the most current version of all documents for continuing review. Include version dates on protocols and ICFs to help with this.
  • You may submit modifications such as revisions to protocols, ICFs, etc. with the continuing review. Just be aware that they will be reviewed at the time of continuing review. Also, track all changes in revised documents
  • All research team members must complete their current mandatory education requirements in order for IRB approval to be granted at continuing review.
  • Remember to report all severe adverse events and clinically significant adverse events that have occurred in the last year with your continuing review submission. You should also submit any DSMB reports or study status summary reports you have received since the last IRB review (initial or continuing).