Screen Failures. A Screen Failure is a consented Study subject who fails to meet the screening visit criteria and is thus not eligible for enrollment into the Study. Screen Failures will be reimbursed, if at all, as outlined in Attachment A (Budget and Payment Schedule). E.
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. 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. 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. 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. 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 B (Financial Arrangements Worksheet) based on the work completed pursuant to the Protocol. The cost of the screening failure will be calculated depending on the procedures performed until the Trial Subject failed the screening. xxxxxxx Any screen failure exceeding this limit will require prior written Sponsor/INC Research approval. To be eligible for reimbursement of Screen failure, the Institution must: (I) allow trial monitor to conduct source document verification for screening, (ii) employ reasonable screening procedures and processes that only appropriate subjects are entered into the screening procedures, and (iii) have proper documentation available for verification, if requested. Subjects recruited due to violation of the inclusion/exclusion criteria will not be eligible for screen failure payments. A-6. 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. Případy neúspěšného screeningu budou uhrazeny, pokud vůbec, v souladu s přílohou B (záznam finančních ujednání), a to na základě práce provedené podle protokolu. Náklady na neúspěšný screening budou vypočteny v závislosti na postupech provedených do doby, než došlo k neúspěchu subjektu ve screeningu. xxxxxxxx. Každý neúspěšný screening převyšující tento limit bude vyžadovat předchozí písemné schválení zadavatele/INC Research. Aby bylo zdravotnické zařízení způsobilé pro úhradu neúspěšného screeningu, musí: (i) umožnit monitorovi klinického hodnocení provést verifikaci zdrojových dokumentů, (ii) používat odůvodněné screeningové postupy a procesy, aby screeningové úkony podstoupily pouze vhodné subjekty hodnocení a (iii) mít k dispozici správnou dokumentaci pro účely verifikace, pokud bude požadována. Subjekty, při jejichž získání byla porušena kritéria pro zařazení/vyloučení, nebudou způsobilé pro platbu za neúspěšný screening.
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. 4.
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. Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently assigned to study intervention. A minimal set of screen failure information will be collected, including demography, screen failure details, eligibility criteria, and any SAE. Individuals who do not meet the criteria for participation in this study (screen failure) may be rescreened. Rescreened participants should be assigned a new participant number.
