Adverse Event Reporting. Good Clinical Practice

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1 Adverse Event Reporting Good Clinical Practice

2 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

3 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.

4 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.

5 Why Report? Legal Requirement Collection of detailed records relating to a Clinical Trial Patient Safety Science: identify adverse reactions specific to a study medicine

6 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 What to Report Requires or prolongs hospitalisation Results in persistent or significant disability or incapacity Is a congenital anomaly or birth defect

7 What to Report Is the event listed in Protocol section 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

8 What to Report Is the event listed in Protocol section as expected? No Is the event causally related to the IMP? No The event is reported as a Serious Adverse Event Complete Form 7

9 What to Report Is the event listed in Protocol section 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

10 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

11 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.

12

13 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.

14 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

15 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. %20Guide%20to%20Good%20Clinical%20Practice.pdf

16 Contact: NPEU Clinical Trials Unit Trial Coordinator - James Griffiths T: F: Lead Research Nurse - Paula Jenkins T: M: Data Coordinator - Monika Vargova T: E: elfin@npeu.ox.ac.uk W: Department of Population Health University of Oxford, Old Road Campus, Oxford, OX3 7LF

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