Some data elements might not be relevant, depending on the circumstances. Attempts should be made to obtain information on as many listed items as are pertinent to the case.

1. Patient details

• Initials
• Other relevant identifier (e.g., patient number)
• Gender
• Age, age category (e.g., adolescent, adult, elderly), or date of birth
• For a parent-child/foetus report the gestation period at time of exposure
• Concomitant conditions
• Medical history including relevant past drug history
• Relevant family history
• Weight of patient
• Height of patient
• For parent-child/foetus reports, information concerning the parent (e.g., parent identification, parent age/date of birth, last menstrual period date, weight, height, sex, relevant medical history and concurrent conditions, relevant past drug history)
• Ethnicity

2. Suspected medicine(s)

• Brand name as reported
• International Non-Proprietary Name (INN) or Australian Approved Name (AAN)
• The AUST R or AUST L number present on label
• Active ingredients
• Batch/lot number
• Indication(s) for which suspect medicine was prescribed or tested
• Dosage form and strength
• Daily dose (specify units e.g., mg, ml, mg/kg) and regimen
• Route of administration
• Parent route of administration (in cases of a parent-child/foetus report)
• Starting date and time
• Stopping date and time, or duration of treatment
• Actions taken with drug (e.g., drug withdrawn, dose reduced, dose increased, dose not changed, unknown, not applicable)
• Additional information on drug
• For suspected drug/drug, drug/food, or drug/alcohol interactions, the names and active ingredients of the suspected interacting products or substances

3. Other treatment(s)

The same information as in item 2 should be provided for the following:

• Concomitant medicines (including non-prescription, over-the-counter medicines, herbal remedies, dietary supplements, complementary and alternative therapies, etc.); and
• Relevant medical devices.

4. Details of adverse reaction(s)

• Full description of reaction(s), including body site and severity
• Reaction as reported by the primary source
• Reaction in MedDRA terminology (lowest level term)
• The criterion (or criteria) for regarding the report as serious
• Description of the reported signs and symptoms
• Specific diagnosis for the reaction
• Onset date (and time) of reaction
• Stop date (and time) or duration of reaction
• Time interval between suspect drug administration and start of reaction
• Dechallenge and rechallenge information
• Relevant diagnostic test results and laboratory data
• Setting (e.g., hospital, out-patient clinic, home, nursing home)
• Outcome of reaction at the time of last observation (e.g., recovered/resolved, recovering/resolving, not recovered/ not resolved, recovered/resolved with sequelae. Describe sequelae)
• Date of death
• Was autopsy done? Relevant autopsy or post-mortem findings, including coroner's report
• Stated cause of death for a fatal outcome
• Relatedness of product to reaction(s)/event(s)
• Assessment of reaction: Source of assessment (e.g., initial reporter, investigator, regulatory agency, company), method of assessment (global introspection, algorithm, Bayesian calculation) and result
• Case narrative including clinical course, therapeutic measures, outcome and additional relevant information
• Sponsor's comments (e.g., diagnosis/syndrome and/or reclassification of reaction/event)
• Whether the case was medically confirmed (medical documentations [e.g. laboratory or other test data] provided by a consumer that support the occurrence of the suspected AR, or which indicate that an identifiable healthcare professional suspects a reasonable possibility of causal relationship between a medicine and the reported AE, are sufficient to consider the spontaneous report as medically confirmed. If a consumer initially reports more than one reaction and at least one receives medical confirmation, the whole report should be documented as a spontaneous report that has been medically confirmed. Similarly, if a report is submitted by a medically qualified patient, friend, relative of the patient or carer, the case should also be considered as medically confirmed.)

5. Details about the person reporting the adverse reaction to the sponsor

• Name
• Mailing address
• Electronic mail address
• Telephone and/or facsimile number
• Reporter type (consumer, healthcare professional, etc.)
• Profession (specialty)

6. Administrative and sponsor details

• Source of report (spontaneous, epidemiological study, patient survey, literature, etc.)
• Date the event report was first received by manufacturer/company
• Country in which the event occurred
• Type (initial or follow-up) and sequence (first, second, etc.) of case information reported to authorities
• Name and address of sponsor
• Name, address, electronic mail address, telephone number, and facsimile number of contact person at the sponsor's Australian address
• Identifying regulatory code or AUST R/AUST L number
• Company/manufacturer's identification number for the case (the same number should be used for the initial and follow-up reports on the same case)
• The AR identification number (if known) of possible duplicate reports initially submitted to the TGA by a consumer, healthcare professional or other primary source