Enrolled Subject definition

Enrolled Subject as used herein means a subject who meets the Protocol eligibility criteria and has signed an ICF and HIPAA Authorization (or country equivalent document) as approved by Gilead.
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Enrolled Subject as used herein means a subject who meets the Protocol eligibility criteria and has signed an ICF and HIPAA Authorization (or country equivalent document) as approved by Gilead. c. A screen failure occurs when a candidate for the Trial fails to meet the eligibility criteria set out in the Protocol, and is, therefore, not enrolled in the Trial. Institution will be paid at the screen failure rate (in the budget) for the procedures used during screening to determine the subject may not be enrolled, upon satisfaction of the same conditions as set forth in Section 5.b above applicable to Visit Fees. The screen failure payment rate and the maximum # of screen failure(s) are listed in the attached budget. The maximum number of screen failures may be increased by Gilead’s prior written approval, in which case no amendment to the Agreement shall be required. 6.
Sample 1
Enrolled Subject as used herein means a b. Každý poplatek za návštěvu bude uhrazen za podmínky, že 1) zařazený subjekt (definovaný níže) absolvoval návštěvu v klinickém hodnocení a 2) společnost Gilead přijala záznam subjektu hodnocení k dané návštěvě. „Zařazeným subjektem“ se zde rozumí subjekt, který splňuje subject who meets the Protocol eligibility criteria and has signed an ICF and HIPAA Authorization (or country equivalent document) as approved by Gilead. kritéria způsobilosti stanovená protokolem a podepsal formulář informovaného souhlasu a potvrzení dle amerického zákona HIPAA (či jiný ekvivalentní dokument v dané zemi) ve verzi schválené společností Gilead.
Sample 1

Examples of Enrolled Subject in a sentence

  • Studies in Which a Previously Enrolled Subject Becomes a Prisoner 11217-10.

  • These measures of accuracy are: • Acceptance of Authentic Enrolled Subject (AA) or Genuine Accept Rate (GAR) • Acceptance of Impostor Subject (IA) or False Accept Rate (FAR) • Rejection of Authentic Subject (RA) or False Reject Rate (FRR) • Rejection of Impostor Subject (RI) or Genuine Impostor Rejection (GRR) The biometric system accuracy requirements depend greatly on the applica- tion.

  • Studies in Which a Previously Enrolled Subject Becomes a Prisoner 118 18-10.

  • The efficacy of the technique is determined by computing the Accuracy of Accepting an Enrolled Subject AAES (%) and Accuracy of Rejecting the Impostor (ARI%).

  • We note the agreement by the finance ministers and central bank governors on cooperation on Public Private Partnerships (PPP), including through PPP experience exchange and application of the BRICS Good Practices on PPP Frameworks.

  • Each payment due will be made based upon prior quarterly enrollment data confirmed by Enrolled Subject CRFs filled in by the PHYSICIAN supporting Enrolled Subject visitation with no outstanding queries.

  • Table 3: Protocol 20061, All Enrolled Lesions, Demographics DemographicsAll Enrolled Subject Population*** Total eligible and evaluable lesions include 1 lesion from the Not Atypical for suspicion of Melanoma (F7)clinical study sites were in the US.

  • Enrolled subjects who prematurely discontinue for any reason before completion of the study will be treated as outlined in the following section.7.4.3. Enrolled Subject Withdrawal and Discontinuations‌7.4.3.1. Withdrawal ProceduresEarly terminations are when an enrolled subject withdraws consent or the Investigator terminates a subject.

  • PMC Schedule Milestones: Final Protocol Submission: 1/2017 Study/Trial Completion: 7/2023 Final Report Submission: 12/2023 Other: First Enrolled Subject 10/2017 1.

  • Sponsor agrees to pay Xxxxx(s) for no more than 3 Screen Failure(s) for every 1 Enrolled Subject the amount for the Screening Visit set forth in the Budget per Study Subject.


More Definitions of Enrolled Subject

Enrolled Subject is defined as a properly enrolled Study subject meeting all of the inclusion criteria requirements and none of the exclusion criteria requirements, who is treated with the Study Drug and completes all Study assessments, procedures, and required follow-up per Protocol (or who has terminated early for a Study-related reason). b) Maximum celkových platieb za Prijatého účastníka („Platba za Účastníka“) je uvedený v Rozpise platieb nižšie. „Zaradený účastník“ znamená riadne zaradený Účastník štúdie, ktorý spĺňa všetky zaraďovacie kritériá a nevzťahujú sa na neho žiadne vylučovacie kritériá, je liečený Študijným liekom, podrobí sa vyšetreniam a postupom Štúdie a požadovanej následnej kontrole podľa Protokolu (alebo ktorý svoju účasť ukončil predčasne z dôvodu súvisiaceho so Štúdiou). c) All amounts represented in the Participant Fee are inclusive of any staff time, overhead and other costs, and will be based upon: o Properly Enrolled Subjects who have completed Protocol-specified procedures and the timely submission of properly completed CRFs to Sponsor; and o Compliance with Investigator & Study Personnel expectations (including but not limited to): c) Všetky sumy zahrnuté v Platbe za Účastníka zahŕňajú pracovný čas personálu, režijné a iné náklady a budú založené na: o počte riadne prijatých Účastníkov, ktorí absolvovali postupy uvedené v Protokole, a včasnom odovzdaní riadne vyplnených a presných údajov v CRF Zadávateľovi; a o dodržaní povinností, ktoré sa očakávajú od Skúšajúceho a Študijného personálu (medzi ktoré patria okrem iného aj): - Performance of the obligations and requirements as they pertain to clinical investigators within ICH E6; - Ensuring that all Protocol-specified evaluations and procedures are performed according to schedule. All procedures are to be performed according to the Protocol and ICH GCP guidelines; - Participation at Site Initiation Visit; - plnenie povinností a požiadaviek vzťahujúcich sa na skúšajúcich uvedených v smernici ICH E6; - zabezpečenie vykonania všetkých hodnotení a postupov uvedených v Protokole podľa harmonogramu; vykonanie všetkých postupov v súlade s Protokolom a smernicami ICH GCP; - účasť na Iniciačnej návšteve centra; - Timely reporting of safety information and Serious Adverse Events; - Interaction with monitors and time spent with monitors at Site visits; - Timely resolution of queries as data collected, verified and entered for analysis; - Maintenance of a screening log of all potential subjects identified ...
Sample 1
Enrolled Subject as used herein means a subject who meets the Protocol eligibility criteria and has signed an ICF and HIPAA Authorization (or country equivalent document) as approved by Gilead. c. A screen failure occurs when a candidate for the Trial fails to meet the eligibility criteria set out in the Protocol, and is, therefore, not enrolled in the Study. Institution will be paid at the screen failure rate (in the budget) for the procedures used during screening to determine the subject may not be enrolled, upon satisfaction of the same conditions as set forth in Section 5.b above applicable to Visit Fees. The screen failure payment rate and the maximum # of screen failure(s) are listed in the attached budget. The maximum number of screen failures may be increased by Gilead’s prior written approval, in which case no amendment to the Agreement shall be required společnost Gilead nebo CRO obdrží veškerou požadovanou a vyplněnou regulační dokumentaci, včetně písemného schválení ze strany etické komise (EK) a 3) společnost CRO obdrží všechny dokumenty uvedené v odstavci 3 výše. b. Každý poplatek za návštěvu bude uhrazen za podmínky, že 1) zařazený subjekt (definovaný níže) absolvoval návštěvu ve Studii a 2) společnost Gilead přijala záznam subjektu hodnocení k dané návštěvě. „Zařazeným subjektem“ se zde rozumí subjekt, který splňuje kritéria způsobilosti stanovená protokolem a podepsal formulář informovaného souhlasu a potvrzení dle amerického zákona HIPAA (či jiný ekvivalentní dokument v dané zemi) ve verzi schválené společností Gilead. c. Neúspěšný screening nastane, pokud kandidát na účast ve Studii nesplní kritéria způsobilosti stanovená v protokolu a tudíž není zařazen do studie. Zdravotnickému zařízení budou za postupy použité při screeningu ke zjištění, zda lze subjekt zařadit, poskytovány platby v poměru neúspěšných screeningů (uvedeno v rozpočtu), a to po splnění stejných podmínek uvedených v oddílu 5.b výše upravujících poplatky za návštěvy. Poměr plateb za neúspěšné screeningy a maximální počet neúspěšných screeningů jsou uvedeny v přiloženém rozpočtu. Maximální počet neúspěšných screeningů je možné zvýšit na základě předchozího písemného souhlasu společnosti Gilead, což nevyžaduje dodatek ke smlouvě. 6.
Sample 1
Enrolled Subject is a Study Subject who, on entrance into the dosing phase of the Study, met all of the inclusion criteria and none of the exclusion criteria in the Protocol, executed the Informed Consent Form, and was enrolled in the Study in accordance with the Protocol. 3.1. „Zaradený účastník“ je účastník skúšania, ktorý pri zaradení do fázy dávkovania splnil všetky kritériá pre zaradenie a žiadne z kritérií pre vylúčenie v protokole, podpísal formulár informovaného súhlasu a bol zaradený do skúšania v súlade s protokolom.
Sample 1

Related to Enrolled Subject

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