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HRP-2XX 4/14/2020 1 of 2
The purpose of this form is to provide additional information for IRB continuing review. This summary must be attached to section 5 of the continuing review form in eProst/IRB7. If this is part of a multi-site study, the questions below pertain only to this site.
IRB Number:
Protocol Name:
Investigator:
Enrollment Status
Check one category below and provide additional information as appropriate
Redacted Velos enrollment summary attached
Retrospective chart/sample review.
records reviewed/samples analyzed since last continuing review
records reviewed/samples analyzed since initial approval.
Other
Total number of subjects who have signed consent:
NOTE: this number must be equal to the sum of the numbers below.
Number of subjects still actively participating:
Number of subjects in long term follow-up
Number of screen failures, withdrawals, and subjects who have completed all participation:
(includes screen failures, withdrawals)
For Studies That Are Closed To New Enrollment ONLY
Check this box if subjects are being re-consented and an updated consent form is required.
Data and Safety Monitoring
Check one box below
DSMB/DSMC/DMC report attached.
There is no external DSMB/DSMC/DMC for this study, PI or other third party is responsible for data and safety monitoring.
Noncompliance (includes “minor deviations”)
Check one box below
Summary log attached.
The PI confirms that no deviation or noncompliance has been identified since last IRB review.
Adverse Events ( “serious” and “non-serious” events that are “unexpected” and “probably related”)
Check one box below
Summary log attached.
The PI confirms that no adverse events have occurred since last IRB review, or
All events are consistent with the nature, severity and frequency described in the study materials.

NUMBER
HRP-2XX
DATE
4/14/2020
PAGE
2 of 2
Summary
Briefly discuss the current state of the study including explanations for any items left unchecked in section 4 of the continuing review form not addressed in a separate document. Include any issues identified since last IRB review:
Reminders to the Principal Investigator
 All members of the research team must maintain current CITI certification in the Course in the Protection of Human
Participants in Research and the Conflict of Interest mini-course. HSRO staff are not authorized to release determination letters if they are unable to confirm such certification.
 All modifications to an ongoing study must be approved by the IRB pursuant to federal regulations prior to implementation. Any changes to the study (including personnel changes) must be submitted via a Modification or a combined Mod/CR.
 New information that must be submitted to the IRB via a separate RNI submission includes: o Information that indicates a new or increased risk o Harms experienced by subjects or others which are unexpected and probably related o Non-compliance with federal regulations or with the requirements or determinations of the IRB, or allegations thereof (excludes “minor deviations”) o Audit, inspection, or inquiry by a federal agency and any resulting reports (e.g. FDA Form 483.) o Written reports of study monitors (if non-compliance or adverse events are identified) o Failure to follow the protocol due to the action or inaction of the investigator or research staff. o Breach of confidentiality. o Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject. o Incarceration of a subject in a study not approved by the IRB to involve prisoners. o Complaint of a subject that cannot be resolved by the research team. o Premature suspension or termination of the protocol by the sponsor, investigator, or institution. o Unanticipated adverse device effect
Investigator Acknowledgement
I will conduct this protocol in accordance with requirements in the INVESTIGATOR MANUAL (HRP-103).
Investigator name Date