Audit Trail – traceability of study data in clinical studies
All actions related to study data are comprehensively recorded in the Audit Trail log. Recorded actions include data entries, changes, views and deletions.
Every action is tracked in detail
A detailed log entry is recorded automatically for every event. Each entry includes, among other things, the user, the date and time, the target of the event and the type of action. Such events include, for example, adding a user, entering and changing data, actions taken by monitors, and breaking or revealing randomisation results in double-blind studies.
Sensitive data kept safe
The Audit Trail log also tracks particularly sensitive actions. These include, for example, viewing or downloading information that identifies participants. This ensures that study data is handled securely, including sensitive information.
Helps you meet even the strictest requirements
Audit Trail log entries cannot be changed or deleted afterwards. This guarantees the integrity and full traceability of study data. Granitics eCRF supports compliance with the key requirements for clinical studies, such as the ICH GCP E6(R3) guideline, the FDA 21 CFR Part 11 regulation and the ISO 14155:2020 standard.
Explore the features of Granitics eCRF
Explore our other features too. Together they cover your study's data collection from planning to analysis.
Self-Enrolment
Granitics eCRF lets participants enrol in a study on a self-service basis. The same feature can also be used to collect data from a target group through surveys.
Online surveys
Surveys are a good way to gather views or experiences on a study topic. Granitics eCRF offers an easy way to run a survey for either a broad audience, such as event attendees, or a defined group. People can take part anonymously, for example at a trade fair via a QR code, or personal links can be sent to a selected group.
Data retrieval and export
The right format for every purpose – study data can be exported in several commonly used formats. The data is ready for analysis, reporting and archiving without extra conversions.
Electronic signature
Granitics eCRF enables study data to be approved with an electronic signature. The feature supports a transparent study process and helps ensure that the data collected can be reliably approved for analysis and reporting.
Monitoring
Granitics eCRF provides comprehensive tools for monitoring clinical studies. Monitoring is a key part of study quality assurance, as it ensures that study data is correct, complete and compliant with the protocol. Granitics eCRF enables efficient monitoring and clear collaboration between the study team and monitors.
Messaging
Granitics eCRF enables secure and traceable communication between the study team and participants. Centralised messaging makes study coordination easier, reduces the risk of errors and ensures that all messages are documented as part of the study process.
ePRO questionnaires
ePRO (electronic Patient-Reported Outcomes) lets participants enter data directly into the study system. They do this by answering questionnaires in a browser-based interface, with no separate apps to install.
Automatic notifications and alerts
Email and text message alerts can be set up for study team members. This way, important events are not missed even when the system is not open.
Double blinding
Granitics eCRF supports double blinding, one of the key methods for ensuring the reliability of clinical study results. In a double-blind study, neither the participant nor the investigator conducting the study knows which group the participant belongs to.
Randomisation
Granitics eCRF includes a built-in randomisation function that supports reliable and transparent clinical studies. Randomisation can be carried out directly in the system without separate tools, which reduces the risk of errors and keeps the study process under control.
Multicentre studies
Granitics eCRF is designed to support multicentre studies in which several organisations, research units or hospitals take part in the same study. The study can be managed centrally while each centre works securely and clearly within its own role.
Clear user interface
The user interface is designed to be clear and intuitive. Study staff learn to use it quickly, leaving more time for the research itself.
Role-based access rights
Granitics eCRF user accounts are personal, and logging in requires two-factor authentication. The study can add new users itself and assign them study-specific roles and access rights. Users can have different roles and permissions in different studies.
Reliable and compliant
Granitics eCRF is a reliable and validated system for clinical research data management. Its design takes into account the requirements that authorities in the EU and the US place on data management systems.
Free online demo
May we show you Granitics eCRF?
In an online demo, we present the features and functions of the eCRF and discuss how it could improve your research. The demo is free of charge and without obligation.
Granitics Ltd