2023-07-12T05:23:23
(iii) a table compiling all observed device deficiencies that could have led to a serious adverse effect, and any corrective actions taken during the clinical investigation, if any;
(iv) any needed subgroup analysis for special populations (i.e. gender, racial /cultural /ethnic subgroups), as appropriate;
(v) an accountability of all subjects with a description of how missing data or deviation(s) were dealt within the analysis, including subjects:—
(A) not passing screening tests;
(B) lost to follow-up;
(C) withdrawn or discontinued from the clinical investigation
and the reason.
8. Discussion and overall conclusions
The conclusions may include the following points:—
(a) the safety and performance results and any other endpoints;
(b) an assessment of risks and benefits;
(c) a discussion of the clinical relevance and importance of the results in the light of other existing data;
(d) any specific benefits or special precautions required for individual subjects or groups considered to be at risk;
(e) any implications for the conduct of future clinical investigations;
(f) any limitations of the clinical investigation.
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