FDA Increasing Oversight On Clinical Research

From Mondaq (free subscription required):

"Over the last several months, the U.S. Food and Drug Administration (FDA) has taken additional steps to increase federal oversight over clinical research. Though not all of these measures are final, the regulatory effort to more closely monitor the accuracy and scientific validity of clinical research data is noteworthy...

Though the focus of the guidance is directed at clinical sites collecting data, the guidance specifically indicates that contract research organizations, data management centers and private sponsors may also use systems subject to this guidance. Therefore, a broad array of private and public entities involved in clinical research may want to consider initiating the development of standard operating procedures for clinical research computerized systems."