Protocol Deviation
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eDeviation® is part of Ethical’s eClinical Software Platforms Solutions supporting faster and more accurate clinical trials management. Whether your protocol deviation assessments are performed by an independent expert committee or by your study team, our eDeviation® software is configured to exactly match your needs.
Forms, workflows and exports altogether contribute to a GxP quality and effectively managed study. Study teams, Investigators’ Sites and Committee Members, when applicable, work seamlessly online in real time to expedite judgements, consensus and timely completion of the protocol deviation assessments and management.
Our solution supports all the operations for Protocol Deviation assessment and management. From software design and validation to collecting supporting documents and exporting data for the TMF, eDeviation® relieves your clinical team from the risks associated to missing or wrongly assessing one-time or recurring protocol deviations.
Save money and time optimizing the setup of multiple studies with different protocol deviation rules.
eDeviation® provides you with a software platform dedicated to you, physically separated from other customers. It can be configured to exactly match your Standard Procedures (SOPs) while retaining the flexibility of using it for many different studies, with their specific forms, workflows, users' roles, custom reports, and exports.
You can match your SOPs with the Flexibility required to serve different Sponsors. You Gain all the possible Economies of Scale of using a single Software Platform for all of your Studies.
KNOW MORETo simplify the day-by-day work of your staff and minimize the risk of delays, omissions and errors.
A Real Time View displaying all the Protocol Deviations in the platform with their current status. It can be configured with custom Attributes and Filters so that each deviation can be easily searched, managed and monitored during its lifecycle. It can be used by your Study Team and Committee Members if you are assessing your deviations independently practically without training.
Your Staff works fast and easily keeping a real-time oversight of the study deviations. CROs can match sponsors' Service Level Agreement for quality and operations timing.
KNOW MORETo collect internal or external reviewers' assessments in the most effective and rules-compliant way.
Assessment Forms design, Field Labels, Edit Checks and Data Variables used to store the Protocol Deviation assessments are designed by Ethical's experienced staff to match exactly each study requirements.
Study Operations can start immediately after the Software delivery without complex staff trainings.
KNOW MORETo support specific processes & workflows for deviations assessment and management.
eDeviation® flexible delivery model has been designed to comply with any procedures that each Sponsor decides to implement.
With a single platform you can manage all your study deviations without training your staff on complex system configurations.
To ensure a timely and compliant execution of your deviations assessment by detecting trends.
We understand the metrics needed by Study Staff for monitoring and reporting. Deviations Assessed, Reviewers' Workload, Statistics per site, Alerts for Outliers and Delays against operational benchmarks, Deviations in each workflow status. Each metric is represented by a dedicated widget that can be printed or exported.
Operations oversight and reporting to your managers or sponsor can't be faster and easier. All operational metrics are available in a single, customizable, view.
KNOW MOREEnsure an efficient Quality Control that follows the most common Standard Practice or can be easily adapted to specific Rules.
Quality metrics are automatically collected throughout the study duration. The Quality Control Dashboard includes all the relevant metrics: Total deviations, number of deviations per-Reviewer, by Time period, by Site, by pair of Reviewers, with Disagreement Rates, etc. A process is available to import a percentage of “clone events” to be re-submitted to the panel for Intra-Variability control.
You can ensure real time Quality Control oversight to your Managers and Study Sponsor without expensive data processing outside the platform.
KNOW MORETo provide Sponsors’ Data Managers with needed data exports during the Study.
eDeviation® provides Data Managers with real-time self service Data Exports. Standard Exports include CSV, XML, Excel files about Audit trail, Events' Lifecycle History, Deviation Review, etc. Other customized formats (e.g. SAS) are available on request.
Deviation Data are always available in real-time as soon as the study starts. They are configured to match your specifications without complex or time-consuming operations.
KNOW MORETo document all decisions and actions performed for all your study deviations.
eDeviation® automatically records all the activity linked to each protocol deviation and displays it in the audit trail.
Your staff easily tracks and documents all the decisions and actions related to each protocol deviation of your study.
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eDeviation
software solution
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The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.
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Helpful links to the FDA and EMA guidance documents that address the difficulties raised by protocol deviations in clinical trials.
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We have assembled a useful repository of links to useful resources to you on your Protocol Violations exploration.
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