TransCelerate has developed a risk-based monitoring methodology that transforms clinical trial monitoring from a model rooted in source data verification (SDV) to a comprehensive approach leveraging cross-functional risk assessment, technology, and adaptive on-site, off-site, and central monitoring activities to ensure data quality and subject safety. Evidence suggests that monitoring methods that concentrate on what is critical for a study and a site may produce better outcomes than do conventional SDV-driven models. This article assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits. The results support the hypothesis that generalized SDV has limited value as a quality control measure and reinforce the value of other risk-based monitoring activities.

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The efficacy of 2 teat dips, product 1 (Della Care with 5 to 8 ppm of free iodine, used as a positive control) and product 2 (New Della Care with 12 to 16 ppm of free iodine), was compared using a natural exposure trial on dairy cattle. The trial was based on National Mastitis Council guidelines and performed over 9 mo. Both teat dips contained 0.25% iodine. Product 2 reduced the infection rate 57.6% for major pathogens and 53.7% for minor pathogens, compared with the positive control. Product 2 gave highly significant reductions for Staphylococcus aureus, coagulase-negative staphylococci, and Corynebacterium bovis. Teat skin, teat ends, and teat hyperkeratosis were evaluated during trial. No significant difference in teat condition was observed between these 2 products.

Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.

We set out to identify predictors of successful voiding immediately after outpatient mid-urethral sling. The charts of 126 patients who underwent an outpatient mid-urethral sling procedure were identified. Using discharge without a urinary catheter as the dependent variable, logistic regression analysis modeled the relationship of independent variables including demographic, preoperative urodynamic, and perioperative variables. Sixty-one percent of the patients passed their immediate postoperative voiding trial. Logistic regression analysis revealed that parity > or = 3, Valsalva leak point pressure > 60 cm H(2)O, and high preoperative anxiety remained independently associated with successful voiding. Identifying preoperative variables that are associated with successful voiding after mid-urethral sling may be useful in helping to accurately shape patient expectations and identify those most likely to benefit from preoperative teaching of self-catheterization.