This could lead to targeted on-site visits to address the issues that such visits are better placed to detect. By implementing these techniques sponsors can not only reduce the cost of clinical trials, but can make better use of resources and optimize overall study success rates. Responsible for leading global sales, product, marketing, operational and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years international commercial experience within life sciences, healthcare and telecommunications.
In the past, Patrick consulted on corporate and commercial strategy for various life sciences companies and was responsible for successfully positioning ClinPhone as the leading Clinical Technology Organization during his year tenure with the company. Save my name, email, and website in this browser for the next time I comment. Ask yourself how likely it is that a specific risk will pop up. If the risk actually turns up, what is the potential damage?
And is there a chance to detect the occurrence on time or even at all? On the basis of your risk evaluation, in a next step you need to decide which risks are negligible, i. Clearly define the risk level which is still acceptable and from which point on you will initiate preventive or corrective actions in order to reduce or eliminate the hazard.
In case that during the trial a risk exceeds the defined risk level, the process automatically asks for the determination of corrective actions. Always make sure to continuously document and communicate all risk-based quality management related activities. Only then you can guarantee for transparency and common processes that facilitate the smooth conduct of your study. Risk control is a crucial process throughout your entire study — from its design and conduct to its analysis and final study report.
It is important to continuously review and, if necessary, adapt your predefined risks, their evaluation and their corresponding risk tolerance levels. Naturally, during the course of the trial new risks might arise, other risks might become less relevant or might need an adaptation of their risk acceptance level. As mentioned above, in the final clinical study report describe the specifically performed quality management approach and clarify important deviations from your predefined tolerance limit.
At the moment, many sponsors and CROs are on the way to develop their system for the implementation of a risk-based quality management. Certainly it has always been a goal to minimize potential risk in clinical trials. And errors occurring during the course of the study have been followed by a CAPA Corrective and Preventive Action process already in the past.
However, unlike the procedure up until now, the described risk-based approach is based on a systematic, structured and documented examination method which takes place in the run-up to the beginning of the study.
Different templates are available, e. It is essential to recognize, to minimize and to control the most important risks — we have to live with the additional existing risk of potentially neglecting risks that have been evaluated as less important or irrelevant. Risk-based quality management — the new magic phrase in clinical research Risk-based quality management — the new magic phrase in clinical research.
Among the best known guidelines are:. Risk-based Quality Management becomes a legal obligation. It is a critical component of the lexicon of modern monitoring topics. Taking a risk-based approach to study quality and the monitoring of any clinical investigation has a simplistic focus:. However, RBM is a very nuanced approach. While critical risks could be monitored any number of ways, including the types outlined above — On-site, Remote, and Centralized — the end effort is more often a combination of these methodologies.
All three clinical trial monitoring methods can be used in concert for effective oversight, monitoring and for the protection of data integrity and patient safety. The FDA has issued three guidances on the use of risk-based monitoring in recent years. This guidance centers on sponsor oversight and study conduct.
The end aim is to improve participant protections while improving data integrity. Specifically, this guidance covers how sponsors, CROs, and researchers can develop a monitoring approach. It involves the development of monitoring plans as well as how to communicate results.
The most recent guidance from the FDA regarding risk-based monitoring came out in March
0コメント