E2A

Key data elements for: Suspected Medical Products

*Brand Name as reported *International Non-proprietary Name (INN) *Batch Number *Indication(s) for which suspected medicinal product was prescribed or tested *dosage form and stength *daily dose and regimen *route of administration *starting date and time of day *stopping date and time, or duration of treatment

Key data elements for: patient details

*Initials *Other relevant identifier (clinical investigation number) *Gender *Age and/or date of birth *Weight *Height

Key data elements for: Administrative and Sponsor/Company Details

*source of report: was it spontaneous, from a clinical investigation (provide details), from the literature (provide copy), other? *date event report was first received by sponsor/manufacturer *country in which the event occurred *type of report filed to authorities: initial or f/u (first, second...) *name and address of sponsor/manufacturer/company *name,address, telephone number, and fax number of contact person in reporting company or institution *identifying regulatory code or number for marketing authorization dossier or clinical investigation process for the suspected product (IND or CTX number, NDA number) *sponsor/manufacturer's identification number for the case (number must be the same for the initial and follow-up reports)

Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product).

Minimum criteria for reporting

An identifiable patient, a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected, and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available.

Serious Adverse Event

Any event that: (1) results in death; (2) is life-threatening (patient at risk of death at the time of the event); (3) results in inpatient hospitalization or prolongation of existing hospitalization; (4) results in a persistent or significant disability/incapacity (5) results in a congenital anomaly/birth defect; or (6) based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed above.

Terms to describe causality between a medicinal product and an event

Certainly, definitely, probably, possibly or likely related or not related

Key data elements for: Other Treatments

For concomitant medicinal products (including non-prescription/OTC medicinal products) and non-medicinal product therapies, provide the same information as for the suspected product

Key data elements for: Details of Suspected Adverse Drug Reaction(s)

Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious should be given. In addition to a description of the reported signs and symptoms, whenever possible, attempts should be made to establish a specific diagnosis for the reaction. *start date and time of onset of reaction *stop date and time or duration of reaction *dechallenge and rechallenge information *setting (hospital, out-patient clinic, home, nursing home...) Outcome: information on recovery, what specific tests and/or treatments may have been required and their results; for a fatal outcome, cause of death and a comment of possible relationship to the suspected reaction should be provided.

Key data elements for: Details on Reported of Event

Name, address, telephone number, profession (speciality)

Reporting time frame for fatal or life-threatening unexpected ADRs

Regulatory agencies should be notified ASAP but no later than 7 calendar days after first knowledge by the sponsor, followed by as complete of a report as possible within 8 additional calendar days

How to report

The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting; its important that certain basic information be included with any expedited report

Adverse Event

Untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment

Adverse Drug Reaction (ADR): marketed medicinal products

a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

Adverse Drug Reaction (ADR): pre-approval clinical experience

all noxious and unintended responses to a medicinal product related to any dose; causal relationship between a medicinal product and an adverse event is at least a reasonable possibility

Reporting time frame for all other serious, unexpected ADRs

serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed ASAP but no later than 15 calendar days after first knowledge by the sponsor

Purpose of Expedited Reporting

to make regulators, investigators, and other appropriate people aware of new, important information on serious reactions. Such reporting will generally involve events previously unobserved or undocumented.