Study Report QC-
Approximately 80 pages of a study report, to be submitted in 510K. Final draft expected to be available April 15, looking for a QC completion date of May 1. Report will be provided electronically. Content QC required- checking study report body content against tables listings and figures. Formatting QC most likely not needed- to verify. Extent of QC- to be discussed. Will either be 100% QC or risk based (random 10%, N-1 or other). The study itself was 80 patients, 12 weeks, 3 US sites (NYU, Stanford, TJeff), robust data- safety and efficacy of course but also detailed QOL and diaries. Also achieved very good patient diversity.
Sheila here with an update on this opportunity- They want 100% QC of 1) all numbers cited in the text against tables, listings and figures. 2) all cross references. If an error is found and corrected, use track changes but also keep a list in excel- page number, error described, etc. They are reviewing the final draft now, then will the MW making those changes, they anticipate the final for QC will be ready on Monday April 24. The medical writer on it thinks the QC effort should take no more than one week, so are looking for turnaround by May 1.