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: elfin@npeu.ox.ac.uk W: www.npeu.ox.ac.uk/elfin

Department of Population Health

University of Oxford, Old Road Campus, Oxford, OX3 7LF