Data integrity you can actually inspect
Governance for Every Electronic System and Trail.
Clinical-trial data is increasingly created, transferred and reviewed through computerized systems. The controls around those systems must be proportionate to their intended use and to the importance of the data or activities they support.
Data integrity principles.
MDTrials uses established data-integrity principles, including ALCOA+ concepts, to guide how records are created, corrected, reviewed, retained and made available. These principles are implemented through applicable procedure and system controls rather than used as a stand-alone claim.
Access, Validation, Audit trails, Covered
Control areas
- Fit-for-purpose system selection and documented intended use
- Validation and assurance proportionate to system risk and use
- Role-based access and access review
- Audit-trail configuration and review where applicable
- Change control for relevant configuration and system changes
- Backup, recovery and continuity arrangements
- Defined data lifecycle and retention
- Oversight of third-party and hosted systems within assigned responsibilities
Technology does not transfer accountability
Automation and digital tools can reduce administrative work and improve visibility. They do not replace qualified review or transfer accountability away from the person or organization responsible for the trial activity. Where any tool contributes to a regulated record or a trial decision, a qualified person remains accountable for review and approval.
Frequent Questions
- What does ALCOA+ mean?Attributable, legible, contemporaneous, original and accurate — plus complete, consistent, enduring and available. It describes the qualities trial records must have to be reliable and inspectable.
- Do you validate the sponsor's systems?No. Where a sponsor provides the EDC or other systems, validation remains with the system owner. We control our use of and access to those systems within our assigned responsibilities.
- Q. How do you use AI tools in trial work?Where digital tools including AI assist administrative tasks, their use is governed by our quality management system and every output touching a regulated record is reviewed and approved by a qualified person.
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