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This study was a retrospective proof-of-concept trial and the data have been retrospectively evaluated for the future preparation of a controlled prospective trial, which will require a submission to the local Ethics Committee.
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This makes it crucial that any decision-making process that relies on the submission of evidence by manufacturers will require a clearly written and internally consistent submission with justification for the use of data sources.
During the presubmission process, the FDA and sponsor teams will usually come to an agreement whether the biomarker assay device will require a PMA, 510 k), or de novo submission.
The National Institute for Health Research's BRC/BRU funding will require a minimum silver Athena Swan award, which can only be obtained following a submission to the Equality Challenge Unit (ECU).
Choreographing the latter event will require a heroic distillation of fifty years' worth of fiction, poetry, essays, and interviews — published work culled from a flood of material that, in recent times, has averaged twenty thousand annual submissions.
This will require a screwdriver.
Specifically, beginning on 1 January 2013, we will require all submissions to report HbA1c levels in both traditional units (i.e., reported as %, derived Diabetes Control and Complications Trial [DCCT] units) and Système International (SI) units (reported as mmol/mol).
Any Non-Approved Outside ECE Course will require the submission of a Petition if you want to count it as a Core Course.
Funding for P1 and P2 will require the submission of a project budget for equipment, facilities, trained coaching staff and volunteers, publicity and participant transport.
Overnight events will require submission of a guest list 7 days prior to the event.
Her relationship with DeMalo is not one of equals; he will require her submission and more.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com