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.
kgas
Poland
Local time: 14:34


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


  

Answers


7 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
okoliczności mogące znacząco wpłynąć na zgodność badania


Explanation:
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

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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