Spontaneous Reports definition

Spontaneous Reports means any unsolicited communication to any Party describing an AE or a Special Situation, including, without limitation those received from consumers, health professionals, Internet sources, Regulatory Authorities, reports received from non-company registries, regulatory databases, literature reports or other situations where there is unstructured or unsolicited collection.
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Spontaneous Reports from Patient Support Programs or Marketing Research Programs includes all Adverse Reactions reported from any program designed to encourage the HCP or consumer to voluntarily contact the company for educational material or support. Any program which does not systematically include any questions that request safety information in response.
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Spontaneous Reports an unsolicited communication by a healthcare professional or consumer to a company, the local regulatory authority or other organization (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal Product(s) and that does not derive from a study or any organized data collection scheme. Suspected Adverse Event: an AE which is thought to be related to the medicinal drug is “suspected”. In general, all spontaneous reports are considered suspected for expediting purposes. Unexpected Adverse Drug Reaction: an Adverse Drug Reaction where the nature, frequency, severity, specificity or outcome is not consistent with the term or description used in the Investigator’s Brochure or local/regional product information (i.e. SmPC, PIL, labels or package insert) labelling (PIL or SmPC). An otherwise expected ADR with a fatal outcome should be considered unexpected unless the appropriate product label specifically states that the ADR might be associated with a fatal outcome. Valid Case: a case which includes the minimum information required for all reporting purposes, consisting of an identifiable reporter (source), an identifiable patient, a suspected medicinal product(s) and an AE/ADR.
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Examples of Spontaneous Reports in a sentence

  • SRs (Spontaneous Reports) and literature reports concerning the Products are outside the scope of this current Pharmacovigilance Agreement.

  • This Agreement covers: • all Spontaneous Reports and/or Solicited Reports of Adverse Events in relation to the Product; • all Serious Adverse Reactions arising from clinical trials and post-marketing surveillance (PMS) with the Product; • all information required for periodic reporting in relation to the Product; and • the reporting of all other information as required by Regulatory Authorities for the Product.

  • This Section 3 applies solely to Spontaneous Reports for the Medicinal Products from all sources received by each Party and reports for the Medicinal Products from all other sources except Clinical Studies.

  • Licensee shall provide to Oncolytics information of Spontaneous Reports in the Territory in writing, using any mutually agreed format within the timeframes defined in Section 8.3. The reporting form shall include all the information provided by the Spontaneous Source.

  • Spontaneous Reports Non-serious AEs from spontaneous source are sent as separate line-listing within the respective "Periodic Safety Update Report" (see 5.1.3.).

  • All Spontaneous Reports received from consumers or health care professionals are considered as suspected Adverse Drug Reactions.

Related to Spontaneous Reports

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, Chief Executive Office State and the Borrower State and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

  • Progress Reports The Progress Reports as required by the individual Task Work Orders issued pursuant to this Agreement. Responsible: Responsible or Responsibility means the financial ability, legal capacity, integrity and past performance of Contractor and as such terms have been interpreted relative to public procurements. See NYS Finance Law § 163(1)(c).

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CREFC® Operating Statement Analysis Report The monthly report in the “Operating Statement Analysis Report” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.