Evaluable Patient means (a) a patient who met all clinical trial inclusion/exclusion criteria, received the correct dose and is considered evaluable pursuant to the most recent protocol for the applicable Clinical Trial that was included in the IND (or amendment thereof) for such Clinical Trial that has been submitted to a Regulatory Authority and has been cleared (e.g., elapse of [*] after submission of the IND to the FDA without response from the FDA), and (b) for each such patient described in clause (a), all reported clinical responses are confirmed under the then-current Response Evaluation Criteria in Solid Tumors (such criteria commonly referred to as RECIST) or other generally accepted clinical response criteria for the applicable specific clinical setting, as specified in the applicable protocol (as described above) for such Clinical Trial.
Evaluable Patient. A Study patient who was screened and Enrolled in accordance with the Protocol (evaluable participants are defined as those with an evaluable CTA at baseline and follow-u) received at least one dose of study medication and adhered with the procedures requested by the Protocol. This includes Study patients who are withdrawn by reason of adverse event or any other reason that is not the responsibility of Institution and/or Investigator or Study patients who withdraw due to death, during the Study. All investigations have been entered into the electronic case report form (“eCRF”) and all queries arising from Sponsor or Covance’s monitoring were clarified. „Hodnotitelný pacient“ – pacient ve studii, který podstoupil screening a byl zařazen do studie v souladu s protokolem (hodnotitelní účastníci jsou definováni jako subjekty s hodnotitelnou CSA při výchozím stavu a následných kontrolách), obdržel alespoň jednu dávku hodnoceného přípravku a dodržel postupy požadované protokolem. Do této skupiny patří i pacienti ve studii, jejichž účast byla ukončena z důvodu nežádoucí příhody nebo z jiného důvodu, za který nezodpovídají zdravotnické zařízení ani zkoušející, nebo pacienti, jejichž účast skončila v důsledku úmrtí během studie. Všechna vyšetření byla zanesena do elektronického formuláře případu („eCRF“) a všechny dotazy vzešlé z monitorování zadavatelem nebo společností Covance byly zodpovězeny. Institution and Investigator understand and agree that the terms and amounts mentioned in this Exhibit B cover any and all fees to Institution and Investigator, including any costs which are to be allocated by Institution or Investigator to any other involved department, to Research Staff, if any and costs and expenses to be incurred by Institution or Investigator under this Agreement. Poskytovatel a Zkoušející chápou a souhlasí, že podmínky a částky uvedené v této příloze B obsahují veškeré úhrady Poskytovateli a Zzkoušejícímu, včetně všech případných nákladů, které budou Poskytovatelem nebo Zkoušejícím proplaceny jakémukoli jinému zapojenému oddělení a výzkumným pracovníkům, a výdaje a náklady vynaložené Poskytovatelem nebo Zkoušejícím podle této smlouvy.
Evaluable Patient. A Study patient who was screened and Enrolled in accordance with the Protocol, received at least one dose of study medication and adhered with the procedures requested by the Protocol. This includes Study patients who are withdrawn by reason of adverse event or any other reason that is not the responsibility of Institution and/or Investigator or Study patients who withdraw due to death, during the Study. All investigations have been entered into the electronic case report form (“eCRF”) and all queries arising from Sponsor or Covance’s monitoring were clarified. Institution and Investigator understand and agree that the terms and amounts mentioned in this Exhibit B cover any and all fees to Institution and Investigator, including any costs which are to be allocated by Institution or Investigator to any other involved department, to Research Staff, if any and costs and expenses to be incurred by Institution or Investigator under this Agreement. 1.
Examples of Evaluable Patient in a sentence
For each Evaluable Patient, payment will be made according to actual visits performed and the evaluable data produced and entered correctly in the eCRF.
More Definitions of Evaluable Patient
Evaluable Patient. A Study patient who was screened and randomised into the IVRS/IWRS in accordance with the Protocol, received at least one dose of study medication and adhered with the procedures requested by the Protocol. This includes Study patients who are withdrawn by reason of adverse event or any other reason that is not the responsibility of Institution and/or Investigator, or Study patients who withdraw due to death, during the Study. All investigations have been entered into the electronic case report form (“eCRF”) and all queries arising from Sponsor or Covance’s monitoring were clarified. “Screen Failures” – Screened study patients who, following the Protocol screening period, did not fulfil Protocol Eligibility criteria that allowed them to be randomised in the IVRS/IWRS or patients who, following the Protocol screening period decided not to participate further in the Study and withdrew their consent prior to being randomised in the IVRS/IWRS. 1.
Evaluable Patient. A Study patient who was screened and randomised into the IVRS/IWRS in accordance with the Protocol, received at least one dose of study medication and adhered with the procedures requested by the Protocol. This includes Study patients who are withdrawn by reason of adverse event or any other reason that is not the responsibility of Institution and/or Investigator or Study patients who withdraw due to death, during the Study. All investigations have been entered into the electronic case report form (“eCRF”) and all queries arising from Sponsor or Chiltern’s monitoring were clarified.
Evaluable Patient. A Study patient who was screened and enrolled in accordance with the Protocol, received at least one dose of study medication and adhered with the procedures requested by the Protocol. This includes Study patients who are withdrawn by reason of adverse event or any other reason that is not the responsibility of Institution and/or Investigator or Study patients who withdraw due to death, during the Study. (b) “Screen failures” - Screen Failures are defined as screened Study patients who, following the Protocol screening requirements, did not fulfil inclusion and exclusion criteria and were deemed ineligible to participate in the Study based on the results from Protocol required procedures and/or assessments prior to receiving their first dose of Study drug. 1. DEFINICE (pokud není definováno v protokolu jinak): (a) „Hodnotitelný pacient“ – pacient ve studii, který prošel screeningem a byl zařazen do studie v souladu s protokolem, xxxxxx alespoň jednu dávku hodnoceného přípravku a dodržoval postupy vyžadované protokolem. Do této skupiny patří i pacienti ve studii, jejichž účast byla ukončena z důvodu nežádoucí příhody nebo z jiného důvodu, za který nezodpovídají poskytovatel ani zkoušející, nebo pacienti, jejichž účast skončila v důsledku úmrtí během studie. (b) „Neúspěchy ve screeningu“ – neúspěchy ve screeningu jsou definovány jako pacienti, kteří podstoupili screening pro studii a po screeningových požadavcích protokolu nesplňují kritéria pro zařazení a podmínky pro vyloučení a nepovažují se za způsobilé pro účast ve studii na základě výsledků postupů a/nebo vyšetření vyžadovaných protokolem, které se provádějí před podáním první dávky hodnoceného přípravku.
Evaluable Patient means an eligible Patient who meets the criteria in the Protocol which must be met and documented on a Case Report Form in order to be judged evaluable for analysis.
Evaluable Patient means a patient who meets the criteria for payment as outlined 2 - 2 - in the Guidelines for Payment (see Exhibit B).
Evaluable Patient a patient who has passed the inclusion and exclusion criteria; signed the informed consent; received the study drug by the dose, route, regimen, and duration as specified in the Protocol; had adequate documentation of primary efficacy and safety variables; and been adequately followed to establish valid endpoints of safety and efficacy. D. "FDA" - the United States Food and Drug Administration. E. "IND" - a claimed Investigational New Drug Application. F. "Institutional Review Board" or "IRB" - any of the boards established pursuant to 21 C.F.R. Part 56 for the purpose of reviewing clinical research studies. G. "Investigator" - the licensed physician who is a qualified clinical investigator willing and able, and engaged by PPD in accordance with this Agreement, to perform the Study. H. "NDA" - a New Drug Application. I. "Protocol" - the clinical testing procedures and conditions set forth in XXXXXXXXXX Protocol 9008, attached hereto as EXHIBIT A and incorporated by reference herein. J. "SOPs" - PPD's current standard operating procedures for conducting and monitoring clinical trials approved by XXXXXXXXXX. K. "Study" - the clinical evaluation of the safety and efficacy of the Study Drug pursuant to the Protocol.