Screen Failures. 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 Failures will be reimbursed, if at all, as outlined in Attachment C (Financial Arrangements Worksheet). A-9.
Screen Failures. 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 Failures will be reimbursed, if at all, as outlined in Attachment B. A-7. Neúspěšný screening. Případ neúspěšného screeningu se vztahuje na subjekt klinického hodnocení, který nesplní kritéria screeningové návštěvy, a tudíž není způsobilý k zařazení do klinického hodnocení („Případ neúspěšného screeningu“). Případy neúspěšného screeningu budou uhrazeny, pokud vůbec, v souladu s přílohou B.
Screen Failures. Screen failures are subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, and prior to randomization to product/dispense of study product. The Investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-used.
Screen Failures. Estimated [NUMBER] screen failures per site will be provided for, if necessary, at the rate of the screening visit and all performed procedures. Screen failure payments will reflect the screening visits actually completed in accordance with the table 1 above. All screen failure payments are subject to monitor verification.
Screen Failures. 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 Failures will be reimbursed, if at all, as outlined in Attachment C, based on work completed pursuant to the Protocol. B-7. Nevhodný subjekt. Nevhodný subjekt je subjekt, který souhlasil s účastí v klinickém hodnocení, ale nesplnil kritéria základního vyšetření. Nelze ho tedy zařadit do klinického hodnocení. Za nevhodné subjekty mohou být uhrazeny náklady dle přílohy C, a to na základě práce vykonané podle protokolu.
Screen Failures. For Trial Subjects that are determined by INC Research and/or Sponsor to be Screen Failures (as defined below), payee will be reimbursed the full cost of the screening visit, as set forth in Attachment C, per each such Screen Failure. To be eligible for reimbursement of such screening activity, Institution must: (i) submit to INC Research completed screening CRF pages and any additional information, which will be requested by INC Research by latest during CRF control to appropriately document the subject screening procedures, (ii) employ reasonable screening procedures and processes as per protocol to ensure that only appropriate Trial Subjects are entered into the screening process, and (iii) have proper documentation available for verification, if requested. Sponsor and/or INC Research have the right to reduce or cease the screening failure payments, in their sole discretion, upon their review of the documentation relating to the Trial Subjects entered into screening and the screening procedures performed. Furthermore, B-5. Neúspěšný screening. Za subjekty hodnocení, které budou společností INC Research anebo Zadavatelem vyhodnoceny jako neúspešný screening (jak je definován níže), bude příjemci plně uhrazena screeningová návštěva, jak je uvedeno v Příloze C, za každý takový neúspěšný screening. Aby mohla být instituci uhrazena taková screeningová aktivita, instituce musí: (i) předložit společnosti INC Research vyplněné screeningové záznamy CRF a všechny další údaje, které bude společnost INC Research požadovat k řádné dokumentaci screeningových postupů u subjektu nejpozději xxx xxxxxxxx xxxxxxxxxxxx XXX, (xx) použít přiměřené screeningové postupy a procesy dle protokolu, aby bylo zajištěno, že do procesu screeningu vstoupí pouze vhodné subjekty hodnocení, a (iii) na vyžádání mít k dispozici řádnou dokumentaci pro ověření. Zadavatel nebo společnost INC Research mají podle svého výlučného rozhodnutí právo snížit nebo ukončit platby za neúspěšný screening po zhodnocení dokumentace subjektů hodnocení, které such payments will be subject to Sponsor and/or INC Research approval and the other terms and conditions, if any, set forth herein Reimbursement is contingent upon the site monitor or Sponsor designee verifying completion of CRFs for such Screen Failure. Such control cannot be unreasonably delayed. Payments for screen failures shall be made together with quarterly payments for completed subject’s visits. A “Screen Failure” refers to a Trial Subject who h...
Screen Failures. 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 Failures will be reimbursed, if at all, as outlined in Attachment D, based on work completed pursuant to the Protocol. B-5 Vylúčenie pri skríningu. Vylúčením pri skríningu sa označuje situácia, keď Subjekt hodnotenia, ktorý podpísal informovaný súhlas, ale nesplnil kritériá skríningovej návštevy (kritériá pre zaradenie/nezaradenie do štúdie), a teda nie je oprávnený na zaradenie do tohto Hodnotenia. Vylúčenia pri skríningu budú prípadne preplatené podľa Prílohy D, za prácu vykonanú v súlade s Protokolom.
Screen Failures. Vertex will pay for screen failures as specified in the budget. Healthcare Service Provider will provide all screening results as required by the Protocol upon request.
Screen Failures. Screen Failures (as defined below) will be reimbursed at 100% of Screening Visit value in Attachment B-1) per Screen Failure for up to a maximum of 1 Screen Failures for every 3 Study Subjects randomized. Payee shall receive 90% of the Screen Failure payment for such Screen Failure, after data are entered into EDC; the remaining 10% entitlement is to be released according to Section D - Final Payments. A “Screen Failure” refers to a Study Subject who has signed the Informed Consent but failed to meet the inclusion/exclusion criteria during the screening phase or who has signed Informed Consent, meets the inclusion/exclusion criteria, but who was not randomized. No payment will be made for Study Subjects, if any, who are inappropriately or improperly screened. Xxxxx must obtain prior written approval from Sponsor to be reimbursed for more than3 Screen Failures. C
Screen Failures. 2. NEÚSPĚŠNÝ SCREENING:
