extenuating circumstance

12:34 Jul 2, 2018
This question was closed without grading. Reason: Answer found elsewhere

English to Polish translations [PRO]
Medical - Medical (general) / badania kliniczne
English term or phrase: extenuating circumstance
The initial value was inconsistent with the subject’s previous results; due either to error or to an extenuating circumstance.
Local time: 14:34

Summary of answers provided
3 +1okoliczności mogące znacząco wpłynąć na zgodność badania
Frank Szmulowicz, Ph. D.



7 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
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.


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


Frank Szmulowicz, Ph. D.
United States
Local time: 08:34
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 1417

Peer comments on this answer (and responses from the answerer)
agree  Marcin Pustkowski
18 hrs
  -> Dziękuję Marcinie. Serdecznie pozdrawiam. U nas wielkie święto narodowe -Dzień Niepodległości.
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