Solicited reports definition

Solicited reports arise from organized data collection schemes which include clinical trials, post-authorisation studies, registries, post-authorisation named-patient use programmes, other patient support and disease management programmes, surveys of Patients or Healthcare Providers, and information gathering on efficacy or patient compliance
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Solicited reports means safety reports from post-marketing organised data collection systems including non-interventional studies, post-authorisation named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, collection of information on efficacy or patient compliance. Such solicited reports shall be handled in accordance with spontaneous reporting timelines and processes.
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Solicited reports from Patient Support Programs or Marketing Research Programs includes all Adverse Reactions reported from a program where targeted safety questions are systematically included (in either the script or contact form).
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Examples of Solicited reports in a sentence

  • Solicited reports are defined as those derived from organised data collection systems, which include clinical trials, registries, post-approval named patient programmes, other patient support and disease management programmes, surveys of patients or healthcare providers, or information gathering on efficacy or patient adherence.For the purpose of safety reporting, solicited reports should be classified as Individual Case Safety Reports.

  • Solicited reports are defined as those derived from organised data collection systems, which include clinical trials, registries, post-approval named patient programmes, other patient support and disease management programmes, surveys of patients or healthcare providers, or information gathering on efficacy or patient adherence.

  • Contractor also agrees to provide immediately upon request a Department of Apprenticeship Standards (“DAS”) printout with the names and registration information of any workers that are working on the Project as apprentices pursuant to Section 1777.5.

  • Solicited reports are defined as those derived from organised data collection systems, which include clinical trials, registries, post-approval named patient programmes, other patient support and disease management programmes, surveys of patients or healthcare providers, or information gathering on efficacy or patient adherence.For the purpose of safety reporting, solicited reports should be classified as an ICSRIndividual Case Safety Reports.

  • Solicited reports are defined by the ICH as those derived from organised data collection systems, which include clinical trials, registries, post-approval named-patient-use programs, other patient support and disease management programs, surveys of patients or healthcare professionals, or information gathering on efficacy or patient compliance.

  • Solicited reports of injection- site and systemic reactions such as fatigue and myalgia were more among HZ/su than placebo, but the reactions were generally mild-to moderate in intensity and serious AEs and deaths were similar in the vaccine and placebo groups (87-89).

  • The tabulation should include: • Serious and nonserious adverse drug reactions from spontaneous ICSRs, including reports from healthcare professionals, consumers, scientific literature, and regulatory authorities • Serious adverse reactions from non-interventional studies • Solicited reports* of serious adverse reactions The tabulation should include interval and cumulative data presented side-by-side (see Appendix B, Table 7), and should be organized by SOC.

  • Solicited reports are ADR reports the BfArM obtains from industry-funded studies, i.e. interventional or non-interventional pre- or post-marketing studies or retrospective hospital record analyses in contrast to the spontaneous reporting scheme.

  • Data collection took the following forms:• Formal letters to ministries, institutions and universities• Interviews (formal and informal)• Correspondence• Solicited reports from both individuals and cooperators• Questionnaires.

  • Solicited reports shall contain an Applicant's or Marketing Authorisation Holder's assessment of causality between the use of a medicinal product and the development of adverse reactions.


More Definitions of Solicited reports

Solicited reports means those Reports that are derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers or information gathering on efficacy or patient compliance. Adverse Event Reports from these should not be considered spontaneous.
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Related to Solicited reports

  • Required Reports means, collectively, the Servicing Report required pursuant to Section 6.08(b), the Servicer’s Certificate required pursuant to Section 6.08(c), the financial statements of the Servicer required pursuant to Section 6.08(d), the tax returns of the Borrower and the Servicer required pursuant to Section 6.08(e), the financial statements and valuation reports of each Obligor required pursuant to Section 6.08(f), the annual statements as to compliance required pursuant to Section 6.09, and the annual independent public accountant’s report required pursuant to Section 6.10.

  • Founded Reports means the Department's Children, Adults, and Families Division or Law Enforcement Authority (LEA) determination, based on the evidence, that there is reasonable cause to believe that conduct in violation of the child abuse statutes or rules has occurred and such conduct is attributable to the person alleged to have engaged in the conduct.

  • Verified Report means the report submitted by the Purchaser to the Head of the Purchaser setting forth its findings as to the existence of grounds or causes for termination and explicitly stating its recommendation for the issuance of a Notice to Terminate.

  • Substantiated report means a report of sexual conduct that TSPC or ODE determines is founded.

  • Reports means the reports described in Schedule B as well as any other reports or information required to be provided under the Enabling Legislation or this Agreement;

  • 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.

  • 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.

  • Criminal history record information means records and data collected by criminal justice agencies

  • Pick Up Report means the report detailing the number of sleeping rooms per day actually used out of the Program’s room block.

  • 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).

  • Parent Reports has the meaning set forth in Section 4.5(a).

  • Public statement means a statement made in the ordinary course of business of the public body with the intent that all other members of the public body receive it.

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

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

  • Data Room Information means the information and documents listed in the index of documents contained in the Data Site attached to the Company Disclosure Letter;

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • Quarterly Reports shall have the meaning assigned in Article 6.

  • Mandated reporter means any school personnel who knows or has reason to believe a child is being neglected or physically or sexually abused, or has been neglected or physically or sexually abused within the preceding three years.

  • information folder means the complete folder, including the information document, file, data, drawings, photographs, and so on, supplied by the applicant, it being permissible to supply the information folder in the form of an electronic file;

  • Investigative consumer report means a consumer report or portion thereof in which information about a natural person's character, general reputation, personal characteristics, or mode of living is obtained through personal interviews with the person's neighbors, friends, associates, acquaintances, or others who may have knowledge concerning such items of information.

  • Statement of Additional Information means, respectively, the form of prospectus and statement of additional information with respect to the Fund filed by the Investment Company as part of the Registration Statement, or as they may be amended or supplemented from time to time.

  • Mandated Reporters means any school personnel who has reason to believe that a vulnerable adult is being or has been maltreated.

  • Criminal justice information system means a system including the equipment, facilities, procedures,

  • Extended Reporting Period means a designated period of time after a claims-made policy has expired during which a claim may be made and coverage triggered as if the claim has been made during the policy period.

  • Informant means an individual(s), who voluntarily submits to the Board a Voluntary Information Disclosure Form relating to an alleged violation of insider trading laws that has occurred, is occurring or has a reasonable belief that it is about to occur, in a manner provided under these regulations, regardless of whether such individual(s) satisfies the requirements, procedures and conditions to qualify for a reward;

  • Material Non-Public Information means information which is (a) not publicly available, (b) material with respect to Holdings and its Subsidiaries or their respective securities for purposes of United States federal and state securities laws and (c) not of a type that would be publicly disclosed in connection with any issuance by Holdings or any of its Subsidiaries of debt or equity securities issued pursuant to a public offering, a Rule 144A offering or other private placement where assisted by a placement agent.