Screen Failure definition
Screen Failure is a Study Subject who is not enrolled into the Study because he or she does not meet all inclusion and exclusion criteria or other requirements that must be met for participation in the Study. „Případem neúspěšného screeningu“ se rozumí Subjekt studie, který nebyl do Studie zapsán, jelikož nevyhověl všem kritériím pro zařazení a vyloučení nebo jiným požadavkům, které musí být k účasti ve Studii splněny.
Screen Failure means a Study subject for whom the screening has been performed, including signing the specific Informed Consent Form, but who could not be effectively included in the Study under the exclusion/inclusion criteria set forth in the Protocol for enrolment (ruxolitinib run-in period) or for other justified reasons. ""Pre-Randomization Failure"" shall mean study subject enrolled into the ruxolitinib run- in part of the study but who could not be effectively randomized in the study under the inclusion/exclusion criteria set forth in the Protocol for randomization. Sponsor, through PSI shall pay in total for 3 (three) Screen Failure subjects in accordance with per- procedure costs listed in respective table (Screen Failure), after which Sponsor's approval (email shall suffice) will be required to resume screening procedures. Sponsor, through PSI shall pay for each Pre- Randomization Failure subjects in accordance with per-procedure costs listed in respective table (Pre- Randomization Failure). An enrollment cap may be implemented by the Sponsor on screening at the site (e-mail shall suffice) if 5 or more Study subjects at the Institution are enrolled into the run-in period and 80% or more of them are not suitable for the randomized add-on period." Za "Neúspěšný screening" bude považován screening Subjektu hodnocení provedený včetně podpisu konkrétního Informovaného souhlasu, kdy však subjekt nemohl být efektivně zařazen do Studie dle kritérií pro ne/zařazení uvedených v Protokolu pro nábor (přípravné období s ruxolitinibem) nebo z jiného oprávněného důvodu. Za "Neúspěšný screening subjektu před randomizací" bude považován screening subjektu hodnocení zařazeného do přípravného období s ruxolitinibem, kdy však subjekt nemohl být efektivně randomizován do studie dle kritérií pro ne/zařazení uvedených v Protokolu pro randomizaci. Zadavatel prostřednictvím PSI zaplatí celkem 3 (tři) Neúspěšné screeningy v souladu s rozpisem nákladů na jednotlivé procedury uvedeným v příslušné tabulce (Neúspěšný screening) a poté bude k pokračování ve screeningových procedurách zapotřebí souhlas Zadavatele (postačí emailem). Zadavatel prostřednictvím PSI uhradí náklady za všechny Neúspěšně zařazené subjekty před randomizací v souladu s rozpisem nákladů za jednotlivé procedury uvedeným v příslušné tabulce (Neúspěšně zařazený subjekt před randomizací). Zadavatel smí nastavit strop pro nábor subjektů pro screening v centru (postačí emailem), pokud bude Zdravotnickým zařízením nabráno do p...
Screen Failure is defined as a candidate who enters the screening process based on Protocol defined eligibility criteria, signs the ICF and receives any Study procedure but who is not randomized or enrolled into the Study.
Examples of Screen Failure in a sentence
A Screen Failure is a consented Trial Subject who fails to meet the screening visit criteria and is thus not eligible for enrollment into the Trial.
A Screen Failure is a consented Trial Subject who fails to meet the screening visit criteria and is thus not eligible for enrollment into the Trial (“Screen Failure”).
Screen Failure je Subjekt hodnocení, který již udělil souhlas se zařazením do Studie a který nesplnil kritéria screeningové návštěvy a ▇▇▇ není způsobilý k zařazení do Studie.
A Screen Failure is a consented Trial Subject who fails to meet the screening visit criteria and is thus not eligible for enrolment into the Trial.
The Trial Site will receive payment per Screen Failure for an initial [X] Screen Failures.
More Definitions of Screen Failure
Screen Failure means a subject has, at a minimum, signed the informed consent document for the Study, but does not [Enroll or Randomize] into the Study. 11 655,00
Screen Failure means a Study subject who - was not obviously ineligible, - has completed the Screening Visit procedures as outlined in the Protocol (including, without limitation, the informed consent process) and - is not randomised into the study as it failed to meet the criteria for randomisation and has not received any dose of the Study Drug. - will be reimbursed at amount EUR Payment for screen failures will be made by CRO after CRO has received and reviewed all appropriate eCRFs (data has been entered, or documentation of procedures completed) in addition to any other information that is requested by Sponsor to appropriately document the Study subject screening procedures. Payment for all screen compensation will be paid with the next scheduled payment owed to the Investigator.
Screen Failure. A Screen Failure shall be defined as a Study Participant who has signed an Informed Consent but could not be effectively included in the Study under the inclusion/exclusion criteria or for other reasons. A maximum of 2 (two) Screen Failures shall be paid during the study at a rate of € 238 (two hundred and thirty eight Euro) for S-01 and € 121 (one hundred and twenty one Euro) for S-02 per Screen Failure Study Participant. Neúspešné zaradenie: Neúspešné zaradenie do skú- ▇▇▇▇▇ sa definuje ako taký účastník klinického skúša- nia, ktorý podpísal Informovaný súhlas, ale podľa kritérií pre zaradenie/vyradenie alebo z iných dôvodov nemohol byť zaradený do skúšania. Maximálny počet 2 neúspešných zaradení bude preplatený počas skúša- ▇▇▇ ▇▇ výške € 238 (dvestotridsaťosem Eur) pre S-01 a € 121 (stodvadsaťjeden Eur) pre S-02 na neúspešné zaradenie účastníka klinického skúšania.
Screen Failure. A Screen Failure shall be defined as a Study Participant who has signed an Informed Consent but could not be effectively included in the Study under the inclusion/exclusion criteria or for other reasons. A maximum of 2 Screen Failures shall be paid during the study at a rate of 204,24 € per Screen Failure Subject. Neúspešné vstupné vyšetrenia: Neúspešné vstupné vyšetrenie je definované ako účastník skúšania, ktorý podpísal informovaný súhlas, fakticky sa však nemo- hol zaradiť do skúšania, buď na základe vstup- ných/vylučovacích kritérií alebo z iných dôvodov. Počas skúšania sa majú uhradiť maximálne 2 neús- pešné vstupné vyšetrenia sadzbou € 204,24 na jeden subjekt, ktorého vstupné vyšetrenia boli neúspešné.
Screen Failure. A Screen Failure shall be defined as a Study Participant who has signed an Informed Consent but could not be effectively included in the Study under the inclusion/exclusion criteria or for other reasons. A maximum of 2 (two) Screen Failures shall be paid during the study at a rate of € 230 (two hundred and thirty Euro) per Screen Failure Study Participant. Neúspešné zaradenie: Neúspešné zaradenie do skú- ▇▇▇▇▇ je taký účastník skúšania, ktorý podpísal infor- movaný súhlas, ale podľa kritérií pre zarade- nie/vyradenie alebo z iných dôvodov nemohol byť zaradený do skúšania. Maximálny počet 2 neúspeš- ných zaradení bude preplatený počas Štúdie vo výške € 230 (dvestotridsať Eur) na neúspešné zaradenie účastníka skúšania.
Screen Failure is a consented subject who fails to meet the screening visit criteria and is thus not eligible for enrollment into the Study. Screen Failures will be reimbursed as outlined in Exhibit 1. To receive payment for Screen Failures, the Screening CRFs must be completed. Institution shall request payment for each Screen Failure in accordance with Section 12 (Invoices & Payments), specifying the candidate’s screening number (or other unique identifier) za každý subjekt, který neprošel screeningem, v souladu s odstavcem 12 (Faktury a platby) a uvede při tom screeningové číslo kandidáta (nebo jiný jedinečný identifikační údaj) a datum neúspěšného screeningu. and the date of the Screen Failure.
Screen Failure means a Subject has, at a minimum, signed the informed consent and authorization document for the Study, but does not enroll or randomize into the Study. Screen Failure payments will be made along with Subject Visit Payments, as described below. Not to Exceed $Insert Amount Subject Visit Payments: Payments for subject visits will be made US: monthly, Non-US: quarterly following enrollment of the first Subject. Payments will be made after data is entered by INSTITUTION into the CRFs and reviewed by ABBOTT, and will correspond to amounts listed in Attachment I to Appendix I. INSTITUTION understands that such payments are subject to subsequent verification by ABBOTT and will be adjusted per Section 8 (Compensation) of the Master Agreement if necessary. Checks shall be made payable to (Must be exact name as it appears on the IRS tax form): Federal Employer ID Number: Insert Payee Insert Number Individual and Address to receive Payment at INSTITUTION: Insert Name Insert Address Name and e-mail address of Individual at INSTITUTION to receive detailed payment information: Insert Name Insert e-mail address Individual and Address to receive Invoices at ABBOTT: Payment Specialist ▇▇▇▇▇▇ Laboratories Dept. ▇▇▇▇, ▇▇▇▇ ▇▇▇▇-▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ Road ▇▇▇▇▇▇ Park, IL 60064-6145 ▇▇▇▇▇▇_▇▇▇▇▇▇▇▇@▇▇▇▇▇▇.▇▇▇ If sending electronically, please be sure to include the Study number on the subject line of the e-mail. If the invoice is not study-specific, please include the 5- digit contract number located in the lower left-hand corner of the Statement of Work ▇▇▇▇ ▇▇▇▇▇▇▇ Director Office of Industry Engagement The University of Texas at Austin ▇.▇. ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ Overnight address: ▇▇▇ ▇. ▇▇▇▇ ▇▇▇▇▇▇ North Office Bldg. A (NOA), ▇▇▇▇▇ ▇.▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Phone: ▇▇▇-▇▇▇-▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇ Tax ID: 74-600023 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇.▇. Vice President for Research Administration The University of Texas Southwestern Medical Center ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ Blvd. Dallas, Texas ▇▇▇▇▇-▇▇▇▇ Phone: ▇▇▇-▇▇▇-▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇ Tax ID: ▇▇-▇▇▇▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ Assistant Vice President for Research and Sponsored Programs The University of Texas Health Science Center at San Antonio 7703 ▇▇▇▇▇ ▇▇▇▇ Dr, Mail Code ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ Phone: ▇▇▇-▇▇▇-▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇ Tax ID: ▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Assistant Director, Contracts, Office of Sponsored Projects The University of Texas Health Science Center at Houston ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, Suite 1006 Houston, T...