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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2
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.
Sample 1

Examples of Spontaneous Reports in a sentence

  • Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®.

  • Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer's Capture of Spontaneous Reports for Exposed Pregnancies.

  • Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study.

  • Liu, Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease- Modifying Antirheumatic Drugs for Rheumatoid Arthritis., Fron- tiers in pharmacology 9 (2018) 875.

  • Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis.

  • Having analysed the STRs/SARs, should they reach the required threshold for dissemination, IRs (see table 3.6) are prepared and disseminated to the relevant LEAs. Spontaneous Reports are also disseminated to foreign LEAs once these reports contained information that impact on a foreign jurisdiction.

  • Paw S.G. Petersen, and Ebba Holme Hansen, Global Patterns of Adverse Drug Reactions Over a Decade: Analyses of Spontaneous Reports to VigiBase, Drug Saf 2012; 35 (12): 1171- 1182.

  • Marilia Berlofa Visacri, Cinthia Madeira de Souza, Catarina Miyako Shibata Sato, Silvia Granja, Mecia de Marialva, Priscila Gava Mazzola, Patricia Moriel: Adverse Drug Reactions and Quality Deviations Monitored by Spontaneous Reports; King Saud University, Saudi Pharmaceutical Journal (2015) 23 page 130-137.

  • ICH Guideline E2D; Post-approval Safety Data Management: Definitions and Standards for Expedited Reporting, 3.1.1 Spontaneous Reports.

  • Dr. Farquhar combined five early data sets and four later data sets of Spontaneous Reports (SR) of adverse events associated with Baycol and other statins.

Related to Spontaneous Reports

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, the state where Borrower’s chief executive office is located, the state of Borrower’s formation 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).

  • MI Report means a report containing Management Information submitted to the Authority in accordance with Framework Schedule 8 (Management Information);

  • Status Report has the meaning set forth in Clause 4.1.

  • Benchmarking Report means the report produced by the Supplier following the Benchmark Review and as further described in this Framework Schedule 7;

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • Company’s Reports means (i) the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC, including the audited financial statements contained therein and the information from the Company’s definitive proxy statement for its 2020 annual meeting of shareholders incorporated by reference into the Form 10-K; and (ii) the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the SEC, including the unaudited financial statements contained therein.

  • GLJ Report means the independent engineering reserves evaluation of certain oil, NGL and natural gas interests of the Company prepared by GLJ dated February 11, 2022 and effective December 31, 2021.

  • Information Package means the most recent compilation of financial and other data with respect to the Failed Bank, including any amendments or supplements thereto, provided to the Assuming Institution by the Corporation on the web site used by the Corporation to market the Failed Bank to potential acquirers.

  • ESDM Report means the Emission Summary and Dispersion Modelling Report, dated June 12, 2009, prepared in accordance with the Procedure Document by Golder Associated Ltd. and submitted in support of the application, and includes any amendments to the ESDM Report listed in Schedule A and all up-dated ESDM Reports prepared as required by the Documentation Requirements conditions of this Certificate.

  • MI Reporting Template means the form of report set out in the Annex to Framework Schedule 8 (Management Information) setting out the information the Supplier is required to supply to the Authority;

  • Safeguards Monitoring Report means each report prepared and submitted by the Borrower to ADB that describes progress with implementation of and compliance with the EMP and the RP (as applicable), including any corrective and preventative actions;

  • Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Sales Report means a report in substantially the form set forth in Exhibit B “Royalty Report Form”.

  • Acoustic Assessment Report means the report, prepared in accordance with Publication NPC-233 and Appendix A of the Basic Comprehensive User Guide,by HGC Engineering and dated August 22, 2008 submitted in support of the application, that documents all sources of noise emissions and Noise Control Measures present at the Facility and includes all up-dated Acoustic Assessment Reports as required by the Documentation Requirements conditions of this Certificate to demonstrate continued compliance with the Performance Limits following the implementation of any Modification.

  • insider report means a statement required to be filed pursuant to Section 16 of the Exchange Act (or any successor provisions), by a person who is a director of the Corporation or who is directly or indirectly the beneficial owner of more than ten percent of the shares of the Corporation.

  • Monthly Reports shall have the meaning specified in Section 5.16(b) of the Indenture.