Interactive medical and safety monitoring in clinical trials with clinDataReview: a validated and open-source reporting tool.

Continuous medical and safety monitoring of subject data during a clinical trial is a critical part of evaluating the safety of trial participants and as such is governed by protocol procedures and regulatory guidelines to meet the trial's intended objectives. We present an open-source validated graphical tool (clinDataReview R package) which provides access to the trial data with drill-down to individual patient profiles. The tool incorporates functionalities that facilitate detection of error and data inconsistencies requiring follow-up.

[Design and power analysis: n and confidence intervals of means].

In this study, we analyzed the validity of the conventional 80% power. The minimal sample size and power needed to guarantee non-overlapping (1-alpha)% confidence intervals for population means were calculated. Several simulations indicate that the minimal power for two means (m = 2) to have non-overlapping CIs is .