This blog identifies applicable regulations and outlines regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.
All clinical researcher professionals receive extensive training on Good Clinical Practice and other processes to be followed in their work. A topic that is only superficially covered is why those processes are required.
Estimates about the size and composition of the U.S. principal investigator pool vary widely and are often based upon rather opaque sources. The authors of this article offer a new view on the topic.
While new regulations and incentives for sponsors may help, no negative actions have been taken in the FDA’s oncology review divisions in cases of sponsor failure to conduct more diverse trials, and vague diversity guidance continues to raise concerns.
The words data, metrics, reporting, analytics, and insights are frequently used interchangeably by organizations while assessing a meeting’s results to inform future meeting planning, but the distinctions between them are important.