Press Release (ePRNews.com) - BASEL, Switzerland - Apr 20, 2021 - Ethical GmbH, the Swiss company providing personalized software solutions for clinical research committees management, has developed a new software solution designed to simplify the protocol deviation (PD) assessment and management process.
The new eDeviation®solution will allow clinical trial sponsors, CROs, and EC/IRB to manage all protocol deviations in a single repository, assess them electronically in a blinded or unblinded way, and keep track of all their operations.
Protocol deviations (PD) are a known risk for clinical trials as they may jeopardize the safety, rights, and welfare of subjects and data integrity of the study and therefore violate Good Clinical Practice principles. PDs in clinical trials must be identified and reported to the Institutional Review Board (IRB). They must also be assessed as major or minor according to the impact of the deviation on patient safety and data integrity. Finally, corrective actions must be taken to ensure that the PDs will not occur again in the future, and all decisions and actions must be documented for GxP-compliance.
The management and assessment of PDs generate a heavy administrative burden for clinical research teams. In this context, a software platform having the ability to support and record all the operations for PD assessment and management will greatly facilitate the work of clinical research teams.
“With eDeviation®, Ethical’s range of software solutions for clinical research continues to grow to further help our customers conduct their trials more easily and effectively,” says Mimmo Garibbo, Director of Ethical GmbH. “In a context of increasingly complex clinical trials, we are proud to offer a solution that will help sponsors, CROs and EC/IRB minimize the risks associated with protocol deviations.“
About Protocol Deviations
A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the approved protocol, consent document, recruitment process, or study materials (e.g.: questionnaires) originally approved by the EC/IRB. “Protocol deviation” is a general term encompassing protocol exceptions, changes made to avoid immediate harm to subjects, and protocol violations. Protocol deviations can be either major or minor according to the impact of the deviation on patient safety and data integrity.
About eDeviation® (www.protocoldeviation.com)
eDeviation®is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.