Adverse Event Reporting - NPEU · Serious Adverse Event/Reaction Reporting (CTIMP)Form 7 •Trial...
Transcript of Adverse Event Reporting - NPEU · Serious Adverse Event/Reaction Reporting (CTIMP)Form 7 •Trial...
Adverse Event Reporting
Good Clinical Practice
Definitions and IMP Information The Elfin Dossier describes the physical and
chemical, toxicological pharmacological data on an IMP
No overt toxicity is expected based on published literature about Lactoferrin
AE Adverse Events
AR Adverse Reaction
SAE Serious Adverse Events
SAR Serious Adverse Reactions
SUSAR Suspected Unexpected Serious Adverse Reactions
Serious Adverse Event/Reaction
Reporting (CTIMP)Form 7
• Trial safety must be monitored
continuously while the infant is in the
neonatal unit.
• Infants recruited to ELFIN are all initially
very pre-term or very low birth weight and
are expected to have many adverse
events before their discharge.
Who Reports?
A medically qualified individual at the site is
responsible for assessing causality of an
adverse event or serious adverse event and
cannot be downgraded by others.
Why Report?
• Legal Requirement
• Collection of detailed records relating to a
Clinical Trial
• Patient Safety
• Science: identify adverse reactions
specific to a study medicine
Serious Adverse Event (SAE) is any serious medical
occurrence which is not anticipated and not known to be
related to the condition being studied or the intervention
being used.
In this context, serious means: Any untoward medical
occurrence or effect that at any dose:
• Results in death
• Is life-threatening
• Requires or prolongs hospitalisation
• Results in persistent or significant disability or incapacity
• Is a congenital anomaly or birth defect
What to Report
What to Report Is the event listed in Protocol section 9.1.6 as expected?
If Yes Capture the event in Data Collection Forms 3,4,5 These are events that were expected in that population of infants as listed in the protocol:
• Death (unless unexpected in this population) • Necrotising enterocolitis or focal intestinal perforation • Microbiologically-confirmed or clinically suspected late-onset invasive infection • Broncho pulmonary dysplasia or chronic lung disease • Intracranial abnormality (haemorrhage or focal white matter damage) on cranial
ultrasound scan or other imaging • Pulmonary haemorrhage • Patent ductus arteriosus
• Retinopathy of prematurity
What to Report
Is the event listed in Protocol section 9.1.6 as expected?
No
Is the event causally related to the IMP?
No
The event is reported as a Serious Adverse Event
Complete Form 7
What to Report Is the event listed in Protocol section 9.1.6 as expected?
No Is the event suspected to be related to the IMP?
Yes
Serious Adverse Reaction An SAE which is considered to have been caused by
the administration of the trial medication. For an SAE to be considered as a reaction there must be a
reasonable probability that it was related to the administration of the IMP
SAR = SAE + RELATED TO DRUG Complete Form 7
What to Report Is the event is related to the IMP?
Yes Is the event consistent with the product information
(Protocol, IMP Dossier)? No (N.B. no overt toxicity is expected based on published literature
about Lactoferrin)
Suspected Unexpected Serious Adverse Reaction is where a causal relationship between the medicinal
product and the SAE is a reasonable possibility i.e. cannot be ruled out. The nature or severity is not consistent with
the product information. SUSAR = SAE + Related to Drug + Unexpected
Complete Form 7
What to Report In Summary
All Serious Adverse Events not listed in the
Protocol, any Suspected Adverse Reactions or
Suspected Unexpected Serious Adverse
Reactions should be reported on Form 7
They should be reported as soon as possible
and no later than 24 hours of becoming aware
of the occurrence.
How to Report
• Ensure Form 7 is fully completed and all the sheets are submitted to NPEU within 24 hours of the initial serious adverse event or reaction occurring.
• During event resolution and when the event has resolved, complete the indicated sections of successive submissions of Form 7 and send to NPEU ELFIN as soon as possible.
Changes to Form 7: Serious
Adverse Event Report Form
(CTIMP) • Compliant with Regulations
• More Detail Required
• More Description Required
• More Sections on Form
• Concomitant Medicines Section
• Outcome Resolution Section may require
resubmission of the form
Good Clinical Practice (GCP)
These are the fundamental standards that underpin all clinical research to ensure the:
safety and integrity of research participants
quality of the data
This study must be conducted in compliance with the protocol which has been approved by the Research Ethics Committee and your R&D dept.
http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/Training/Pocket
%20Guide%20to%20Good%20Clinical%20Practice.pdf
Contact: NPEU Clinical Trials Unit
Trial Coordinator - James Griffiths
T: 01865 289 741 F: 01865 289 740
Lead Research Nurse - Paula Jenkins
T: 01865 289 754 M:07771840587
Data Coordinator - Monika Vargova T: 01865 617931
E: [email protected] W: www.npeu.ox.ac.uk/elfin
Department of Population Health
University of Oxford, Old Road Campus, Oxford, OX3 7LF