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!
If your IRB approval 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 or as amendment at any time during the study.
Complete all questions on all forms even if they don’t apply to your study. Just simply check off “NO” if they don’t apply.
Only validated ICFs should be used to consent subjects (these are the ICFs with the IRB validation dates.)
Submit all applicable supporting documentation for all studies that are still enrolling subjects. As a general rule, if you submitted it with your initial submission, you will need to submit the document or an updated version of it, at continuing review (except for Form 1).
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 amendments 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 (except IRB forms which can’t be tracked).
The PI must sign the cover letter and all IRB forms. If the PI may not be available for a long period of time, the PI should consider designating a Co-Investigator as his/her signatory prior to leaving.
All research team members must complete their current mandatory education requirements in order for IRB approval to be granted at continuing review.
Only one hardcopy original continuing review application needs to be submitted. The application can be double-side printed. Please also submit all documents electronically (e.g., on a flash drive or CD; flash drives will be returned). If it is not possible to submit an electronic copy, then just one (1) original copy is acceptable.
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).
Please call the IRB office main line (617) 636-7512 or an IRB Analyst with any questions about continuing review.