Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products.

Monitoring the quality of conduct of clinical trials: a survey of current practices.

Background: There is a little empirical evidence to determine which, if any, monitoring practices best achieve the goals of trial monitoring set forth in ICH E6 under the variable circumstances of different clinical trial settings.

Purpose: The purpose of this project was to describe current methods of monitoring clinical trials and to explore the rationale for the use of those methods.

Methods: An electronic survey of known monitoring practices was developed and sent to over 200 organizations involved in conducting clinical research.

Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database.

Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets. The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and to access the impact of the changes. To accomblish the aim, Target e*CRF was used as the EDC tool for a multinational, dose-finding, multicenter, double-blind, randomized, parallel, placebo-controlled trial to investigate efficacy and safety of a new treatment in men with lower urinary tract symptoms associated with benign prostatic hyperplasia.