Special Situation Reports definition

Special Situation Reports means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure. 1.9
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Special Situation Reports means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure. Sperimentatore sia l’Istituto forniranno ragionevole assistenza a Gilead per consentire a Gilead di conformarsi a tutti i requisiti applicabili. Per “Situazioni particolari” si intendono: a) segnalazioni di gravidanza; b) segnalazioni di errore, abuso, uso improprio o sovradosaggio di farmaci; c) segnalazioni di mancanza di efficacia; d) segnalazioni di reazioni avverse in lattanti a seguito di esposizione al latte materno; e) segnalazioni di reazioni avverse associate a reclami relativi a un prodotto; e f) segnalazioni derivanti da esposizione professionale.
Sample 1
Special Situation Reports means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure. 1.8 Bezpečnostní hlášení Instituce a Zkoušející budou hlásit všechny závažné nežádoucí příhody, Hlášení zvláštních situací (definované níže), a/nebo nebo jiné bezpečnostní problémy, které jsou určeny v Protokolu a v souladu s příslušnými zákony, pravidly a vyhláškami, které, kromě jiných, obsahují ICH-E2A a Směrnici Evropské Unie 2001/20/ES. Pro vyloučení pochybností se tímto sjednává, že Zkoušející i Instituce poskytnou přiměřenou pomoc Gilead, aby mu umožnili vyhovět všem příslušným požadavkům. „Hlášení zvláštních situací“ znamenají: a) hlášení těhotenství; b) hlášení chybného podání, zneužití a nesprávného užití léků nebo předávkování léky; c) hlášení nedostatečné účinnosti; d) hlášení nežádoucích účinků u kojenců po expozici při kojení; e) hlášení nežádoucích účinků spojovaných se stížnostmi na přípravek a f) hlášení související s pracovní expozicí.
Sample 1

Examples of Special Situation Reports in a sentence

  • Institution and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC.

  • Serious adverse events (SAEs), AEs of Special Interest (AESIs), pregnancy reports (including pregnancy occurring in the partner of a male study subject), other Special Situation Reports and Product Complaints (with or without an AE), where the patient has been exposed to the Genentech Product, will be sent on a MedWatch form or CIOMS I form or on Genentech approved reporting forms to Genentech Drug Safety.

  • GenentechThe Sponsor will be responsible for collecting all protocol-defined Adverse Events (AEs) and Special Situation Reports (including pregnancy reports) originating from the Study for the Product.The Sponsor must report all Adverse Events/Serious Adverse events (SAEs), AEs of Special Interest (AESIs) and Special Situation Reports (including pregnancy reports) adequately to Genentech within the timelines described below.

  • Special Situation Reports (“SSR”): One of a) Pregnancy, b) Abuse, c) Medication Error, d) Misuse, e) Off-Label Use, f) Overdose, g) Lack of Effect, h) AEs in infants following exposure from breastfeeding, i) AEs associated with Product Complaints or arising from Occupational Exposure.

  • Investigators will be responsible for collecting all protocol-defined Adverse Events (AEs)/Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Special Situation Reports (including pregnancy reports) and Product Complaints (with or without an AE) originating from the Study for the Product(s).

  • HepQuant is not collecting any information regarding adverse events, serious adverse events, and Special Situation Reports (SSR) with respect to the GILEAD products used in the GILEAD clinical trials.

  • Dr. Stone/ Sponsor will be responsible for collecting all protocol-defined Adverse Events (AEs)/Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Special Situation Reports (including pregnancy reports) and Product Complaints (with or without an AE) originating from the Study for the Product.Investigators must report all the above mentioned single case reports adequately to Genentech within the timelines described below.

  • Training program will also be updated, if required.6.2 Key Monitoring Activities The key monitoring activities are given in Table 3.

  • Provider and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC.

  • All Serious Adverse Events will be reported to Gilead DSPH within 3 calendar days of knowledge of the event and all Nonserious Adverse Events/ Special Situation Reports will be reported to Gilead DSPH within 5 calendar days of knowledge of the event.


More Definitions of Special Situation Reports

Special Situation Reports means: a) pregnancy reports;
Sample 1

Related to Special Situation Reports

  • Asset Management Agreement means, as the context requires, any agreement entered into between a Series and an Asset Manager pursuant to which such Asset Manager is appointed as manager of the relevant Series Assets, as amended from time to time.

  • Financial Monitoring Report or “FMR” means each report prepared in accordance with Section 4.02 of this Agreement;

  • LLC means Limited Liability Company.

  • Financial Services means any service of a financial nature, including (but not limited to) —

  • Environmental Management System means an environmental management system or plan of management to address all environmental risks and to ensure compliance with all Environmental Laws and licences;