Quality Risk Management (QRM)

The conduct of clinical studies can only be justified if these are appropriately planned, accomplished, evaluated and reported ethically and scientifically. These requirements call for implementation of functional quality management systems in all departments involved in the conduct and monitoring of clinical studies. Regulatory requirements and the complexity of study designs are increasing. Hence, many sponsors and CROs are aware of the fact that the existing quality assurance activities such as audits alone are not suitable methods to ensure the required quality of clinical trials. In fact, only 5-10% of all investigators are audited. The large size of studies, the high number of study data as well as the limited resources in quality assurance departments make an effective control of data quality by auditors impossible. Compared to the traditional quality management approach quality risk management focuses on systematic quality issues based on the comprehensive sets of information.

Quality Controlled Trial Management System (QCTMS)

Currently available CTMS tools have been developed predominantly to provide Project Managers with information required to monitor the study status and plan further progress. GCP-Service has developed a Quality Controlled Trial Management System (QCTMS), which offers much more than other systems. QCTMS is provided as an effective risk management tool in accordance with ICH Q9 to identify and evaluate risks before problems occur.


QCTMS is a flexible system which can be adapted according to each clinical study, sponsor or SOP. Individual risk-factor levels can be specified to initiate preventive actions, or as an audit trigger to initiate corrective and preventive actions at the first sign of them developing. Typical parameters such as informed consent process, SAE reporting timelines, recruitment rates, query rates, number of protocol deviations, monitoring frequency and many additional factors can be used to evaluate the risk to data quality, or risks for study subjects. Different risk levels trigger automatic alerts to your Project Management and/or Quality Assurance department.


The use of QCTMS not only effectively improves quality but also saves money by saving man-power. The quality control process within a clinical study is an integral responsibility of the Project Management. Unfortunately, this process is often not carried out as intensively as required due to time pressures, lack of recourses and other priorities. Audits, for the most part, identify quality issues when it is too late to take preventive actions. QCTMS is a flexible online tool which takes over the quality control and reports risks according to the needs of your Project Manager who can then focus on the initiation of preventive actions.