“The right tool for the right job” is a saying that applies in many situations across many industries. When it comes to clinical protocol training, research sites and sponsors need to determine what their ultimate goals are to correctly identify the best training...
Shorter training is an ever-present item near the top of nearly all clinical research site wish lists. The time and energy needed for training is among the many drains that researchers complain about, and the one that clinical trial sponsors have the greatest control...
Although adoption of clinical trial innovations have seen a rapid adoption in the world over the last decade, organizations that lag in adopting new technology and new ways of doing things are more common than not in the clinical research industry. A recent survey by the Tufts Center for the Study of Drug Development (CSDD) indicated that innovations in the clinical trial arena take nearly six years to adopt.
Good customer service starts with a great product. Without that foundation—a product that is reliable and meets client needs precisely—it doesn’t matter how well and quickly customer service can address problems. In other words, a product with a bug count of zero and...
Booming administrative tasks, customized technology systems and redundant certification and training requirements are among the primary factors that clinical research staff say eats up time better spent with patients and adds excessive burden—often uncompensated—to study teams. Tailoring training to both the protocol not only will better assure a sponsor that each employee at a site is getting exactly the training they need, but it will save research staff the time burden of going through training they don’t need.
Research sites are turning to various types of performance metrics to support risk-based management of clinical trials. “The first step in proactive data monitoring is to identify what is possible to mitigate, eliminate, and accept,” Hughes wrote. “This all forms part of various plans, including those for data, training, monitoring, statistical analysis, safety, medical monitoring, quality, and other functional plans.”
Patient enrollment is a common subject of discussion among both sponsors and research sites. Challenges to enrollment can be myriad, and the root causes are hard to pin down. But effective enrollment is critical to the ultimate success of any clinical trial, and there...
Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study at risk. Despite this, protocol deviations seem to be viewed as just part of...
Whether ensuring GCP compliance or the correct application of a study protocol, training is a critical part of any clinical trial. During the life of a study, there may be several points at which a sponsor may require additional or more intensive training to...
As a former CRA, I have spent the better part of my career mentoring, teaching, and helping CRAs become competent at monitoring clinical trials to ensure compliance with protocol and GCP. In light of this experience, I urge all CRAs and monitors to STOP THE MADNESS of...
