n clinical trials, manual management of discrepancies is a true bottleneck: it slows down database lock and increases the risk of human errors. Automating logical checks ensures data integrity from the first data entry. By adopting a digital compliance approach and centralized monitoring with ACTide, you can move from reactive to proactive oversight, improving both efficiency and data quality.
Discover how ACTide optimizes Data Management.
Prevent errors: edit checks in the eCRF
Edit checks are automatic validation controls that verify the consistency and completeness of entered data in real time. An ICH GCP-compliant eCRF, like ACTide eCRF, immediately flags out-of-range or inconsistent fields, preventing errors at the source. This approach drastically reduces “trivial” queries, such as incorrect dates or missing fields, enhancing data integrity and simplifying CRA and Data Manager work in handling protocol deviations.
Key Benefits:
- immediate reduction of manual queries.
- Improved data quality from the first entry.
- Less CRA intervention in query management.
- Proactive monitoring and guaranteed digital compliance.
Discover how ACTide eCRF can prevent errors in your clinical studies.
Smart query management
The query workflow involves opening, responding to, and closing queries, and manual handling can slow down the entire process. A centralized system that tracks every interaction through an Audit Trail is crucial to ensure compliance and accurate oversight of protocol deviations.
With ACTide CRA Tools, you can monitor query status across all clinical sites from a single dashboard, reducing delays and manual interventions and simplifying query management.
Want to see how ACTide can revolutionize the management of your clinical trials?
Identifying and categorizing protocol deviations
In clinical trials, distinguishing between minor deviations and major deviations, significant protocol violations, is essential. Automation enables rapid identification of out-of-window patients or non-compliant treatments, reducing manual work and improving data integrity.
Key Benefits:
- automatic identification of minor and major deviations.
- Fast reporting of out-of-window patients or non-compliant treatments.
- Reduction of manual errors.
- Centralized monitoring of protocol deviations.
- Improved data integrity and support for digital compliance.
Read our article on improving centralized data monitoring.
The role of document integrity
In clinical trials, every query and protocol deviation must be precisely documented to ensure compliance with regulatory authorities such as the FDA and EMA. Document integrity ensures that all corrections are traceable and audit-ready, minimizing the risk of non-compliance or inspection issues.
With ACTide eTMF, documentation is securely and centrally stored, supporting centralized monitoring, digital compliance, and complete clinical trial data integrity.
Discover how ACTide eTMF can ensure secure and compliant documentation.
More quality, less time
Automating edit checks, query management, and protocol deviation monitoring optimizes time and resources in clinical trials. Using digital tools such as ACTide eCRF, CRA Tools, and eTMF ensures full digital compliance and consistent data integrity, improving operational efficiency and data quality.
Main Benefits:
- reduced workload for CRAs and Data Managers.
- Higher data quality from the first entry.
- Faster database lock processes.
- Centralized monitoring and proactive discrepancy management.
- Full support for digital compliance and data integrity.
Do you want to eliminate manual processes in your next study?