Applied Clinical Trials-10-01-2001

Getting answers to the right questions can help you decide how to choose and implement an electronic system that is a good match for your company's SAE reporting needs and its available resources.

A systematic survey of 96 pharmaceutical companies and clinical research organizations revealed which systems sponsors are using for clinical data management and adverse events tracking and reporting.

The EU?s Committee for Proprietary Medicinal Products describes the process clinical investigations should follow.

Making electronic CRFs friendly to both investigators and reviewers is a challenge.

While Health and Human Services builds a comprehensive program to ensure the safety of human subjects, Congress weighs proposals to stiffen the rules.

Readers share their experiences