There are limitations to how much property can be protected after a disaster. In the case of clinical research sites, paper documents can burn, or they can be damaged or destroyed by smoke and water. An important consideration for sites is to develop a disaster preparedness strategy with a focus on transitioning to paperless documentation by moving critical study documents to a digital format.
This Complion question and answer session held with Dr. Harvey Arbit, an adjunct professor at the University of Minnesota College of Pharmacy, provides insights into achieving stress-free FDA inspections.
While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Complion has found sponsor pushback to be a common concern. To that end, Complion offers a few tips to ease the apprehension.
Institutional review boards (IRBs) are ethics review committees that ensure human research subjects’ rights are protected, as well as the rights of the patients who ultimately benefit from the research. Operating under US federal regulations, state laws, and institutional policies, the IRB has the authority to approve, require modification to, and disapprove research. IRBs are an important part of regulatory efforts and their approval is required for all human research. Here’s a quick overview of IRBs and the expectations for working with them.
Approximately 80 percent of clinical research sites polled in a recent Complion, Inc.-sponsored survey said the costs and burden associated with administrative tasks for a single study has increased over the past two years, continuing a five-year upward trend.
Because research study sponsors are continually seeking efficiencies, and all stakeholders in studies have an interest in minimizing the time required of, and the potential risk to, volunteers who participate in studies, there will be a decrease in the number of single drug studies in the future. That is the observation of John Neal, CEO of PCRS Network. In the final post of this four-part series, we explore the evolution of clinical research and the opportunity for collaboration among multiple sponsors based on Neal’s insights.