Adverse drug reaction reporting
[DOC File]Template for Reporting Adverse Events
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There are situations when MedWatch is the preferred method of reporting (e.g. adverse reactions to drug products). In those instances consumers can be referred to Medwatch. (See Section 6, References)
Reporting ADR
List all other drug/s taken at the same time and/ or 3 months before No Other drug/s taken. Brand name of the drug Dose Frequency Route Date started Date stopped Reason/s for using the drug Manufacturer/Batch & Lot No. Management of Adverse REaction
[DOC File]Title: Adverse Drug Reaction Reporting
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Reporting: Any staff who witnesses a suspected adverse drug reaction will notify the nurse. Nurse will immediately contact the physician to report the possibility of an adverse drug reaction. The nurse will complete the nursing section of the Adverse Drug Reaction Report (Attachment A).
Guidance Notes to MAHs re: Pharmacovigilance Obligations
: The problem/adverse event involves . death. OR: The problem/adverse event does not fall under the IRB’s prompt reporting requirements, but in the . PI's. judgment, prompt reporting of the event(s) is in the best interest of the subject (s) because it may affect the safety and/or welfare of subjects and/or change the risk level of the study.
[DOC File]SUSPECTED ADVERSE REACTIONS FORM
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RECORDING, MANAGEMENT AND REPORTING OF ADVERSE EVENTS. ... Specify drug(s) suspected of causing reaction. Provide the name of the drug, the daily dose, frequency (i.e. twice daily) and route of administration (intravenous, intramuscular injection, oral ect.) Specify the start date (Date started) and the last day (Date stopped) of use or treatment.
[DOCX File]Appendix V - Europa
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Title: Adverse Drug Reaction Reporting Author: William C. Hallett Last modified by: Will Hallett Created Date: 1/30/2017 4:16:00 PM Company: Guardian Consulting/Northstar Clinical Other titles: Title: Adverse Drug Reaction Reporting
[DOC File]XXXXXX Nuclear Laboratory
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Pharmacovigilance Obligations & Adverse Drug Reaction (ADR) Reporting Requirements for Medicinal Products for Human Use. 1. Introduction. In line with the Medicines Act 2003, pharmaceutical companies have specific obligations with regards to pharmacovigilance. The information contained in this document is directed to pharmaceutical companies ...
ADVERSE DRUG REACTION AND MEDICATION ERROR …
List of details of the national reporting systems to communicate adverse reactions (side effects) for use in section 4.8 “Undesirable effects” of SmPC and section 4 “Possible side effects” of package leaflet. No reference to the Appendix V should be included in the printed packaging materials.
[DOC File]RECORDING, MANAGEMENT AND REPORTING OF ADVERSE …
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Outcome for each Adverse Drug Reaction: The outcome for each Adverse Drug Reaction reported, should be marked in the related ADR box within the table (eg Adverse Drug Reaction 1 was headache and the outcome was recovered; the Adverse Drug Reaction 2 was rash and the outcome was Symptoms continuing). 1.7
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