Title: Reporting and Managing Events and Incidents in Studies
SOP Number and Version: 6, V1.1
Effective Date: 14/09/2015
Review Date: 14/09/2018
Please check this is the latest version of the SOP on the Joint Research Office website:
www.ucl.ac.uk/jro.
Author:
Name:
Suzanne Binks
Position: Quality Assurance Coordinator
___________________________________
Signature
Date
Approved by:
Name:
Rajinder Sidhu
Position: Deputy Director of Research Support
____________________________________
Signature
Date
Authorised by:
Name:
Nick McNally
Position: Director of Research Support
_______________________________________
Signature
Date
Reporting and Managing Events and Incidents in Studies, SOP 6, V1.1 14/09/2015
Page 1 of 5
Version
Number:
1
Effective
date:
20/04/2015
1.1
14/09/2015
Reason for change:
Author:
First UCLH SOP on event reporting requirements for active
studies.
Clarification on reporting requirements for SAEs for hosted
studies.
Suzanne
Binks
Suzanne
Binks
ACRONYMS
AE
AR
CTIMP
CTU
CRF
IB
ISF
JRO
MHRA
PI
R&D
REC
RN
SAE
SmPC
SOP
SUSAR
UCLH
Adverse Event
Adverse Reaction
Clinical Trial of an Investigational Medicinal Product
Clinical Trials Unit
Clinical Research Facility
Investigator Brochure
Investigator Site File
Joint Research Office
Medicines and Healthcare Products Regulatory Agency
Principal Investigator
Research and Development
Research Ethics Committee
Research Nurse
Serious Adverse Event
Summary of Product Characteristics
Standard Operating Procedure
Suspected Unexpected Serious Adverse Reaction
University College London Hospitals NHS Foundation Trust
BACKGROUND
A number of events can occur throughout a study. Some may be reportable to the sponsor (and
to regulatory bodies) and some may not be. Appendix 1 provides definitions of events that may
occur, whether these are reportable, and any further action to be taken should they arise.
PURPOSE
This SOP defines events that can occur within a study (see appendix 1) and describes the
process for the notification of such events to the JRO as representative of UCLH as a host site.
This SOP covers host reporting requirements for all types of studies.
PROCEDURE
Appendix 1 shows which study events need to be reported and when. For further information
about how to report such events to UCLH as a host site, please see the table below. For
details on how to report events and incidents to the sponsor and regulatory bodies, please
confirm this with the sponsor for the study.
Reporting and Managing Events and Incidents in Studies, SOP 6, V1.1 14/09/2015
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Responsib
le persons
(Who?)
Actions (When? How?)
Research related incidents and near misses
Where an event meets the definition of a reportable incident or near miss, the JRO All
must be informed by reporting the incident through DATIX (the Trust incident
reporting system).
Serious Adverse Events
These should be reported to the sponsor as soon as the event is identified and PI or
within 24 hours. An SAE form should be completed for all SAEs, and can be delegate
obtained from the sponsor.
Where an SAE is unexpected and related to the research in a non-CTIMP, a copy
of the SAE form should be emailed to the JRO, and the event recorded on DATIX.
Urgent Safety Measures
The study PI should be alerted as soon as the requirement for an urgent safety PI
measure has been identified or is suspected.
Urgent Safety Measures can be implemented immediately, without REC, MHRA or
R&D authorisation. However, the JRO must be notified as soon as possible by
emailing randd@uclh.nhs.uk. Where the research is taking place in the CRF/CTU,
they must also be informed.
Protocol Violations and Serious Breaches
The study PI should be alerted as soon as a serious breach or reportable violation PI
has been identified or is suspected. The PI should determine whether the sponsor
should be made aware (following the sponsor’s procedures) and whether there is a
requirement to report to the JRO.
Where the safety of the participant and/or integrity of the data have been PI or
compromised, the sponsor and the JRO (and the CRF/CTU where applicable) delegate
should be informed immediately. The incident should be reported to the JRO
through DATIX. The breach/violation should be recorded on a log kept in the ISF.
Complaints
All complaints from NHS patients from UCLH should be reported in the first PI
instance to the UCLH NHS Complaints Manager: complaints.officer@uclh.nhs.uk.
The JRO will work with the study team, division and complaints department to
resolve the matter.
REFERENCES
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice/Seri
ousBreachesReporting/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyreporting
-SUSARsandASRs/
Reporting and Managing Events and Incidents in Studies, SOP 6, V1.1 14/09/2015
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Appendix 1 - Definitions of events and reporting/recording requirements.
REPORTING REQUIREMENTS FOR INCIDENTS AND EVENTS
Event
Definition
Reportable
incident to the
sponsor
Check with
Sponsor
Reportable
incident to
JRO (Host)
Yes
Further action to
be taken
Incident or
Near Miss
Any unintended or unexpected event
that could have or did lead to harm,
loss or damage that contains one or
more of the following components:
Any untoward medical occurrence in a
patient or clinical trial subject
administered a medicinal
product/intervention, which does not
necessarily have a causal relationship
with this treatment.
Any untoward and unintended
response to an investigational
medicinal product/procedure related to
any dose administered/intervention.
No
No
No
No
Any untoward medical occurrence or
affect that:
Yes, within 24
hours
Yes, where
this is
unexpected
and related to
the research,
and the study
is not a
CTIMP
This should be
documented in the
patient notes/CRF,
followed up, and
recorded on the AE
log kept in the ISF.
This should be
documented in the
patient notes/CRF,
followed up, and
recorded on the AE
log kept in the ISF.
An SAE form should
be completed and
submitted where
appropriate. This
should also be
documented in the
patient notes/CRF,
followed up, and
recorded on an AE
log kept in the ISF.
a.
b.
c.
d.
e.
Adverse
Event
(AE)
Adverse
Reaction
(AR)
Serious
Adverse
Event
(SAE)
a.
b.
c.
d.
e.
Suspected
Serious
Adverse
See sponsor’s
reporting
requirements.
It is an accident or other
incident which results in injury
or ill health.
It is contrary to specified or
expected standard of patient
care or service.
It places patients, staff
members, visitors, contractors
or members of the public at
unnecessary risk.
It puts the Trust in an adverse
position with potential loss of
reputation.
It puts Trust property or assets
in an adverse position or at
risk of loss or damage.
results in death
is life threatening
requires hospitalisation or
prolongation of existing
hospitalisation
results in persistent or
significant disability or
incapacity
is a congenital anomaly or
birth defect
An adverse reaction that is classed in
nature as serious and which is
consistent with the information about
Exception:
where this is
listed in the
protocol, IB or
SmPC that this
may not need to
be reported.
Check with the
Sponsor.
Check with
Sponsor
No
This should be
documented in the
patient notes/CRF,
Reporting and Managing Events and Incidents in Studies, SOP 6, V1.1 14/09/2015
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Reaction
(SSAR)
the medicinal product listed in the
relevant reference documentation:
a.
b.
Suspected
Unexpected
Serious
Adverse
Reaction
(SUSAR)
c.
Urgent
Safety
Measure
Protocol
Deviation
Protocol
Violation
Serious
Breach of
Protocol
and/or
Good
Clinical
Practice
Summary of Product
Characteristics (SPC) in the
case of a licensed product
being used within its licensed
dosage and indication.
An Investigator’s Brochure
(IB) or a simplified IMPD in the
case of any other IMP or a
licensed product being used
outside its licensed dosage
and indication
An adverse reaction that is classified in
nature as both serious and unexpected.
That is, it is not consistent with
information laid out;
a.
b.
followed up, and
recorded on the AE
log kept in the ISF.
Yes, within 24
hours
No
An SAE form should
be completed and
submitted where
appropriate. This
should also be
documented in the
patient notes/CRF,
followed up, and
recorded on an AE
log kept in the ISF.
Yes,
immediately
Yes
See sponsor’s
reporting
requirements.
No
No
If patient safety
or data integrity
has been
compromised,
yes.
If patient
safety or data
integrity has
been
compromised,
yes.
A protocol deviation
log should be kept in
the ISF.
See sponsor’s
reporting
requirements.
Yes,
immediately
Yes
in the protocol
in the summary of product
characteristics (SmPC)
in the IB relating to the trial in
question.
An emergency measure taken to
protect a research participant from an
immediate hazard to their health and
safety.
An unintended departure from the
expected conduct of the study
protocol/SOPs.
Can occur when there is a consistent
variation in practice from trial protocol
or SOPs.
A violation can be classified as serious
if there is a significant occurrence
which affects participant safety or
integrity of the research.
Regulation 29A of the Medicines for
Human Use (Clinical Trials)
Regulations 2004 [Statutory Instrument
2004/1031], as amended by Statutory
Instrument 2006/1928, contains a
requirement for the notification of
“serious breaches” of GCP or the trial
protocol:
See sponsor’s
reporting
requirements.
A breach which is likely to effect to a
significant degree –
a.
b.
The safety or physical or
mental integrity of the subjects
of the trial; or
The scientific value of the trial.
Reporting and Managing Events and Incidents in Studies, SOP 6, V1.1 14/09/2015
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