Adverse Event Reporting definition

Adverse Event Reporting means the procedure relating to drug safety and/or pharmacovigilance concerning Products as separately agreed upon between the Parties.
Sample 1Sample 2Sample 3

Examples of Adverse Event Reporting in a sentence

  • Refer to the 'CTEP, NCI Guidelines: Adverse Event Reporting Requirements' http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf for further clarification.

  • Adverse Event Reporting PeriodThe study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up.

  • These include: o Training on the DSHS system for documenting vaccine encounters during the event o Training on the DSHS system for collecting ImmTrac2 consent forms o Training on the DSHS Data Logger you will be issued on the event day by the COVID-19 Vaccine Storage Facility o Training on the Vaccine Adverse Event Reporting System (VAERS) o Training on How to Prepare All Physical Event Paperwork for Submission to the Appropriate Texas Public Health Entity.

  • Adverse events will be followed by the investigator as specified in Section 12, Adverse Event Reporting.

  • Department: Clinical GovernanceTitle: Framework for Adverse Event Reporting, Management and Learning Refer to Other Documents:Incident Reporting, Management and Learning Policy 2016.

  • In addition, the Pregnancy Information Form included within the NCI Guidelines for Adverse Event Reporting Requirements must be completed and submitted to CTEP.

  • Please see the “NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs” (at http://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm) for more details on how to report pregnancy and its outcome to CTEP.

  • If you see signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat,dizziness, or weakness), call 9-1-1 and get the person to the nearest hospital.For other signs that concern you, call your health care provider.Adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS).

  • Otherwise, call your doctor.• Reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS).

  • FDA Adverse Event Reporting System (FAERS)‌The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.

Related to Adverse Event Reporting

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Day reporting means a program of enhanced supervision

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Rapid(ly) report(ing means within 72 hours of discovery of any cyber incident.

  • Serious Adverse Event means any adverse event that led to any of the following:

  • 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.

  • Reporting Material means all Material which the Grantee is required to provide to the Commonwealth for reporting purposes as specified in the Grant Details and includes any Existing Material that is incorporated in or supplied with the Reporting Material.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • ABS Informational and Computational Material means any written communication as defined in Item 1101(a) of Regulation AB under the 1933 Act and the 1934 Act, as may be amended from time to time.

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • 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;

  • Incident Report means a written report of any injury, accident, acts of physical aggression, or unusual incident involving an individual.

  • 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.

  • Sustainability Report the annual non-financial disclosure report prepared in accordance with the Standard for Sustainability Reporting publicly reported by the Borrowers and published on an Internet or intranet website to which each Bank and the Administrative Agent have been granted access free of charge (or at the expense of the Borrowers).

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

  • 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.

  • Reporting Party means any person who alleges that a student has violated this Code.

  • 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).

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Coordinated licensure information system means an integrated process for collecting, storing, and sharing information on nurse licensure and enforcement activities related to nurse licensure laws that is administered by a nonprofit organization composed of and controlled by licensing boards.

  • Consumer reporting agency means any person which, for monetary fees, dues, or on a cooperative nonprofit basis, regularly engages, in whole or in part, in the practice of assembling or evaluating consumer credit information or other information on consumers for the purpose of furnishing consumer reports to third parties, and which uses any means or facility for the purpose of preparing or furnishing consumer reports.

  • reporting_reference_date otstnd ng_nmnl_amnt";"bwdpt_amnt";"periodic_repayment_ due";"periodic_interest_payment_due";"next_intrst_rt _reset_dt";"cumulative_repayments";"cumulative_pre payments";"annlsd_agrd_rt";"accrued_interest";"exit_ status";"dflt_stts";"securitized_instrument_indicator";" past_due_instrument_indicator" Alpha-numeric Semicolon-separated string of all column names. Field names are put in double quotation marks. 1 reporting_agent_identifier Variable characters (60) 60 identifier domain 2 obsrvd_agnt_cd Variable characters (60) 60 identifier domain 3 cntrct_id Variable characters (60) 60 identifier domain 4 instrmnt_id Variable characters (60) 60 identifier domain 5 reporting_reference_date Date reporting reference date 6 otstndng_nmnl_amnt Decimal (12,0) 12 euro amount (non-negative) with unknown 7 bwdpt_amnt Decimal (12,0) 12 euro amount (non-negative) with exclusions 8 periodic_repayment_due Decimal (12,0) 12 euro amount (non-negative) with unknown 9 periodic_interest_payment_due Decimal (12,0) 12 euro amount (non-negative) with unknown 10 next_intrst_rt_reset_dt Date date with exclusions 11 cumulative_repayments Decimal (12,0) 12 euro amount (non-negative) with unknown 12 cumulative_prepayments Decimal (12,0) 12 euro amount (non-negative) with unknown 13 annlsd_agrd_rt Decimal (12,0) 12 real number (positive or negative) with exclusions 14 accrued_interest Decimal (12,0) 12 euro amount (positive and negative) with unknown 15 exit_status Variable multibyte (255) 255 code 16 dflt_stts Variable multibyte (255) 255 code 17 securitized_instrument_indicator Variable characters (50) 50 securitisation indicator 18 past_due_instrument_indicator Variable characters (50) 50 past due instrument indicator 2.3.22 household.csv‌

  • Adverse Environmental Condition shall refer to (i) the existence or the continuation of the existence, of an Environmental Emission (including, without limitation, a sudden or non-sudden accidental or non-accidental Environmental Emission), of, or exposure to, any substance, chemical, material, pollutant, Contaminant, odor or audible noise or other release or emission in, into or onto the environment (including, without limitation, the air, ground, water or any surface) at, in, by, from or related to any Equipment, (ii) the environmental aspect of the transportation, storage, treatment or disposal of materials in connection with the operation of any Equipment or (iii) the violation, or alleged violation of any statutes, ordinances, orders, rules regulations, permits or licenses of, by or from any governmental authority, agency or court relating to environmental matters connected with any Equipment.