GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||
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08:31 Jul 13, 2020 |
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English language (monolingual) [PRO] Medical - Medical: Pharmaceuticals / Clinical ttudy | |||||||
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| Selected response from: Nadyiia Derkach Ukraine Local time: 10:06 | ||||||
Grading comment
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SUMMARY OF ALL EXPLANATIONS PROVIDED | ||||
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3 +3 | adding, enrolling aditional people |
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4 | Completion/Execution |
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Discussion entries: 2 | |
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Completion/Execution Explanation: An example:"Subjects enrolled to backfill cohorts may be enrolled simultaneously...... |
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Notes to answerer
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cohorts backfilling adding, enrolling aditional people Explanation: https://www.centerwatch.com/clinical-trials/listings/115900/... Looks like this is adding more subjects to completed groups. Quote: For cohorts in dose escalation, concurrent with the 3+3 dose escalation schema, additional subjects will be backfilled to lower dose levels to ensure that each cohort enrolls a total of 10 subjects. Subjects enrolled to backfill cohorts may be enrolled simultaneously, without sequential dosing (i.e., not required to wait 48 hours between 2 subjects). These additional subjects at each dose level will have the purpose of generating additional safety, PK, and receptor occupancy data, and will not undergo formal DLT observation. |
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