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Jul 2, 2018 12:34
5 yrs ago
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English term
extenuating circumstance
English to Polish
Medical
Medical (general)
badania kliniczne
The initial value was inconsistent with the subject’s previous results; due either to error or to an extenuating circumstance.
Proposed translations
(Polish)
3 +1 | okoliczności mogące znacząco wpłynąć na zgodność badania | Frank Szmulowicz, Ph. D. |
Proposed translations
+1
7 hrs
okoliczności mogące znacząco wpłynąć na zgodność badania
Screening assessments will be completed within 28 days prior to
the Day 1 visit. The screening window can be extended up to 42 days in
extenuating circumstances, including the need for a liver biopsy or
additional HCV genotyping (if initial testing is inconclusive). Study
visits will occur at Screening, Day 1, and on-treatment at the end of
Weeks 1, 2, 3, 4, 5, 6, 8, 10, and 12. Following the last dose of study
medication, all subjects will complete 4-Week, 12-Week and 24-Week
Posttreatment Visits.
Screening Visit
Screening assessments will be completed within 28 days of the Day 1 visit. The screening window
can be extended up to 42 days for subjects requiring a liver biopsy, additional HCV genotyping (if
initial testing is inconclusive), or for extenuating circumstances with sponsor approval. A single
retest of screening labs is permitted only if there is reason to believe the retest value will be within accepted parameters if the initial value was either due to a sample processing error or due to an extenuating circumstance such as intercurrent infection.
https://clinicaltrials.gov/ProvidedDocs/33/NCT02738333/Prot_...
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Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities
https://clinicaltrials.gov/ct2/show/NCT00894075
the Day 1 visit. The screening window can be extended up to 42 days in
extenuating circumstances, including the need for a liver biopsy or
additional HCV genotyping (if initial testing is inconclusive). Study
visits will occur at Screening, Day 1, and on-treatment at the end of
Weeks 1, 2, 3, 4, 5, 6, 8, 10, and 12. Following the last dose of study
medication, all subjects will complete 4-Week, 12-Week and 24-Week
Posttreatment Visits.
Screening Visit
Screening assessments will be completed within 28 days of the Day 1 visit. The screening window
can be extended up to 42 days for subjects requiring a liver biopsy, additional HCV genotyping (if
initial testing is inconclusive), or for extenuating circumstances with sponsor approval. A single
retest of screening labs is permitted only if there is reason to believe the retest value will be within accepted parameters if the initial value was either due to a sample processing error or due to an extenuating circumstance such as intercurrent infection.
https://clinicaltrials.gov/ProvidedDocs/33/NCT02738333/Prot_...
ccccccccccccccccccccccc
Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities
https://clinicaltrials.gov/ct2/show/NCT00894075
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