advocate aurora health (aah) rspp significant new information significant new information is any information that could impact the condu

Advocate Aurora Health (AAH) RSPP
Significant New Information
Significant New Information is any information that could impact the
conduct or design of the research study or may impact a subject’s
willingness to participate in the research, but the information is NOT
reportable to the IRB as an Unanticipated Problem (UP) or incident of
Noncompliance. [see RSPP guidance on Significant New Information.)
Significant New Information not reportable as UP or Noncompliance
should be reported as soon as possible, but in no case, no later than
14 working days from the date of discovery or report to/from
regulators.
AAH IRB Protocol #:   / Protocol Title:  
Principal Investigator:
 
Contact Person:  
Contact Person’ s E-mail:
 
Contact Person’s Phone:  
Date of discovery:  
AAH RSPP USE ONLY
Noncompliance with reporting window - notify submitter/PI
Please check the type of information ATTACHED to this form:
Significant New Information that indicates an increase in the
frequency or magnitude of a previously known risk, or describes a new
risk. Often found in sponsor report or action letter, adverse event
report, interim analysis findings, safety monitoring report, or
investigator finding.
DMC or DSMB reports containing information that has the potential to
affect subject safety, or recommends study alterations (e.g. early
termination, additional or different procedures).
Other DMC or DSMB reports should be submitted at the time of
continuing review.
An investigator brochure, package insert, or device labeling is
revised that indicates an increase in the frequency or magnitude of a
previously known risk, or describes a new risk
Audit or inspection reports by 1) a federal agency; 2) study monitor
or 3) CQAIR.
Withdrawal, restriction, or modification of a marketed approval of a
drug, device, or biologic used in a research protocol
Change in study status (e.g. temporary halt to enrollment) due to
subject safety issues (equipment malfunctions or drug supply issues)
New risks discovered on a different study using the same drug/device
that are potentially relevant to the current study (ie. occur in a
similar subject population or with the same dose) – often found in
publications.
Complaint of a subject that cannot be resolved by the research team
but does not indicate that subjects or others may be at increased risk
of harm or at risk of a new harm
Other:  
1.
Provide a brief summary of the new information.  
2.
Has the study sponsor addressed the significant new information in
the IRB approved protocol? Check this box if you have submitted a
Change In Previously Approved Research form revising the protocol
or consent document based on this new information.
a.
If NO, has the sponsor indicated that they intend to address
the significant new information in the IRB approved protocol?
If YES, when?  
3.
Has the sponsor conducted an analysis of the reported
issue/information?
a.
If YES, describe action taken and provide results if known: 
 Check this box if information is attached.
b.
If NO, do they intend to conduct an analysis? If YES, provide
timeframe if known.  
4.
In the Investigator’s judgment, could this new information affect
an enrolled subject’s willingness to continue participation in
this research study?
a.
Briefly state your plan for informing enrolled subjects of the
new information, including the timeframe.   Check this box
if you have submitted a Change In Previously Approved Research
form with subject notification documents (e.g. letter,
telephone script, consent addendum).
5.
In the investigator’s opinion, does the significant new
information warrant a change in the enrollment status of the study
(e.g. closure of the study to enrollment –permanently or
temporarily)? Check this box if you have submitted a Change In
Previously Approved Research form revising the study enrollment
status.
a.
If NO, explain why no change in enrollment status is
necessary.  
ATTESTATION [must be completed prior to submission]
If Submitter is not the PI, Submitter certifies that PI has been
notified of Significant New Information report.
Upload the completed form along with any applicable attachments into
IRBNet

For RSPP Use Only
Initial Review/Determination
Initial review by:  _________________/ _____(date)
The reported information describes a reportable UP (RSPP SOP 7) or an
incident of Noncompliance (RSPP SOP 5). Refer submitter to the
appropriate reporting form.
The reported SNI does NOT describe information that requires further
review. No further action is necessary.
The reported SNI is not reportable via another mechanism and indicates
a change in study design or conduct OR that it may affect a subject’s
willingness to continue participation. Requires further review by the
convened board. Place on the next available AAH IRB meeting agenda.: 
_____(date) PR:  _______________ I have no SI related to this study
IRB determination documented below and in the meeting minutes.
Convened IRB determination/action:  
________________________________________________________________________________________________________________________
Form 411 v.11.17.17 Aurora Health Care Research Subject Protection
Program and IRB Office
CPA __________
 Copy returned to submitter by ______
Tel: 414.219.7744 / e-mail: [email protected]
Website: www.aurora.org/irb

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