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Pharmacovigilance Dr. Muiris Dowling,
CRRO UCC version 1.0
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Clinical Research Reporting Officer
Report to Vice President of Research and Innovation Independent of the Cork CRF Act as Sponsor Representative Assist UCC to meet statutory Sponsor responsibilities including: - Approvals (Protocol & ICF review, signatures etc.) - GCP compliance - Monitoring / Auditing oversight - Pharmacovigilance - Training version 1.0
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Pharmacovigilance Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. version 1.0
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Pharmacovigilance Adverse Event: Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Adverse Reaction: A response to a medicinal product which is noxious and unintended. version 1.0
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Pharmacovigilance Serious Adverse Event: Any Adverse Event that results in: Death Is life-threatening Requires in-patient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability or incapacity A congenital anomaly/birth defect Important Medical Event / other version 1.0
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Pharmacovigilance Other safety data:
Any issue in a clinical trial that impacts on either the risk or the benefit to subjects (or the study). version 1.0
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Pharmacovigilance Other safety data: Patients cannot tolerate IMP
Obvious there is no benefit Clear that the alternative (including placebo or nothing) is better New report of a study which highlights efficacy or safety issues for IMP version 1.0
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Pharmacovigilance Other safety data; Quality issues: Tablets crumbling
Capsules fall apart in the hand IMP discoloured Labels fall off Obvious one batch is accounting for all Adverse Events Temperature excursions not reported Expired IMP dispensed version 1.0
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Pharmacovigilance Other safety data;
Misuse of IMP (e.g. suppository swallowed) Patient giving some to friend, relative or daughter Patients child taking IMP (accidentally) Overdose (accidental or intentional) version 1.0
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Pharmacovigilance Other safety data; IMP taken while pregnant
IMP taken while breastfeeding version 1.0
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Pharmacovigilance Investigator:
Report SAEs to the Sponsor within 24 hours Send any follow-up within the same timeframe Pregnancy reports must be handled in the same way and must be followed up version 1.0
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Pharmacovigilance Sponsor: Report SUSARs
Fatal or life threatening within 7 days All others within 15 days version 1.0
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Pharmacovigilance MedDRA (Medical Dictionary for Regulatory Activities) Standardised medical terminology coding dictionary Academic institutions have free access Helps to harmonise terminology version 1.0
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Pharmacovigilance Eudravigilance version 1.0
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Pharmacovigilance EVWeb version 1.0
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Pharmacovigilance Sponsor:
Must maintain oversight of safety profile of the study (and maintain oversight of Investigator) version 1.0
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Pharmacovigilance If any change to risk or benefit – must notify HPRA and Ethics Committee even if it is felt that no change is necessary (HPRA or EC may not agree). version 1.0
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Thank you Questions? 18 version 1.0
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