Version Date: 6/2016
Saint Louis University
Institutional Review Board (IRB)
POST- IRB APPROVAL SUBMISSION REQUIREMENTS
Federal regulations require ongoing study oversight by an IRB. After initial IRB approval, any changes to the
protocol or consent materials, serious or unanticipated events, protocol deviations, requests for continuing
review, etc. must be submitted to the IRB for review. Below is a summary of events requiring submission to the
IRB after initial approval. Contact the IRB Office at 314-977-7744 or irb@slu.edu with questions/concerns.
Type of Event
When to
Form to Use
Submit
SERIOUS ADVERSE EVENTS (SAEs) OR UNANTICIPATED PROBLEMS (UPs)
Internal Serious Adverse Event involving a death
or a life-threatening experience
Other Internal Serious Adverse Events;
Unanticipated Problems
Submit within 3
days of the event
Submit within 7
calendar days
SAEs: SAE Form in eIRB; SAE
Form for paper protocols
UPs: Report Form in eIRB;
Change-in-Protocol/ For
Information Form for paper
protocols
Reference Links
Requirements for
Reporting Events
Related to Subject Safety
Instructions for
completing the SAE form
SAFETY ALERTS/SUBJECT COMPLAINTS/AUDITS/DSM REPORTS/PROTOCOL VIOLATIONS/DEVIATIONS
Safety Alert or other information that suggests a
change to a risk or benefit of the research
Submit within 10
working days
Serious subject complaints, breaches of
confidentiality
Notify IRB within
24 hours
Audit or Monitoring Reports
Audits within 10
working days;
monitor reports
within 30 days
Submit within 10
working days of
receipt
PD before
implementing
Data Safety & Monitoring (DSM) Reports
Protocol Violation (PV) or Protocol Deviation (PD)
Note: Urgent PDs can be approved by IRB via email prior to official paperwork being submitted.
Report Form in eIRB; Changein-Protocol/ For Information
Form for paper protocols
Call/e-mail to IRB followed by
Report Form in eIRB; Changein-Protocol/ For Information
Form for paper protocols
Report Form in eIRB; Changein-Protocol/ For Information
Form for paper protocols
Requirements for
Reporting Events
Related to Subject Safety
Report Form in eIRB; Changein-Protocol/ For Information
Form for paper protocols
Report Form in eIRB; Changein-Protocol/ For Information
Form for paper protocols
PV within 7
calendar days of
becoming known
CHANGES TO PROTOCOL, FINAL DSMB CHARTERS, UPDATED IBs
Changes to Protocol, Personnel, Consent Forms,
Recruitment Materials, Questionnaires, etc;
Updated Investigator’s Brochure (IB); Final
Versions of DSMB Charter
** Multi-center protocol amendments that change
risks, inclusion/exclusion criteria or study design
should be submitted to the IRB within 15 business
days of receipt**
Submit as soon as
possible, IBs
within 15 working
days; do not
implement
changes prior to
IRB approval
unless for subject
safety (email IRB).
Amendment in eIRB; Changein-Protocol/ For Information
Form
Requirements for
Reporting Events
Related to Subject Safety
CONTINUING REVIEWS
Continuing Reviews (CR) are required by federal
regulations no less than once annually.
Submit at least 4Continuing Review Form in
NOTE: Be aware of expiration date and IRB
6 weeks before
eIRB; Continuing Review Form
deadlines. As a courtesy, the IRB will send
IRB approval
for paper protocols
reminder notifications, but the PI is
expires.
responsible for submitting the CR form prior to
expiration.
NOTICE OF STUDY CLOSURE
For non-exempt protocols, submit when study is
See Reference
Final Report in eIRB
Closure of Human
completed or will discontinue.
Link
Research Studies
RECORD RETENTION
Research records for studies involving human subjects must be retained for at least 3 years (6 years if HIPAA applies) after the
completion of the study (closure of study). This is a federal requirement. Note: study sponsors may have additional requirements.