Risk-Based Management

To support a risk-based approach to managing your clinical trial, Clinical Ink offers Targeted SDR. This is a risk-based approach to data that is required to be reviewed based on either pre-determined criteria (e.g., screen fails ONLY require specific fields and forms to be reviewed) and/or certain data being entered (e.g., BMI increase >10% between visits). Targeted SDR allows sponsors to focus the management of their clinical trial data based on a risk-based approach grounded in the principles of TransCelerate and the Risk Assessment Categorization Tool (RACT). This leads to increased data quality, patient safety and efficiency. The benefits include:


  • Earlier detection of issues with a greater focus on resolution and prevention of issue recurrence
  • Reduced efforts expended on low-value activities
  • Reduced costs through more focused centralized monitoring activities and targeted onsite monitoring
  • Greater compliance with Good Clinical Practice (GCP) and relevant regulatory requirements
  • More collaborative cross-functional team approach to support the coordination of monitors, data managers, statisticians, medical monitors and site staff

Clinical Ink’s Capture and Engage solutions support three specific approaches for sponsors’ risk-based monitoring strategies. These include:

1Engagement Compliance Monitoring

Insight provides both detailed and summary tracking for percentage complete action by patients with respect to all assigned engagement tasks. These tasks are part of the patient engagement strategy and are designed to improve questionnaire compliance as well as medication and visit adherence. Monitoring the task completion rate highlights patients who might be at risk in these categories.

2Questionnaire Compliance Monitoring and Alerting

Insight provides both detailed and summary tracking of required questionnaire compliance. Sponsors and study teams are able to monitor the overall study and/or site compliance data as well as patient-specific metrics. These metrics allow corrective action to be taken regarding patients falling below targeted thresholds. Further, daily email summaries and alerts notify sponsor, sites and study teams of compliance problems. Email alerts can be deployed with study-specific compliance.

3Specific Response Monitoring and Alerting

Clinical Ink ePRO solutions support summary alerts to ensure sites and study teams are informed of specific conditions reported by patients. These alerts provide information regarding at-risk responses provided by patients within questionnaires, which may require site and study team follow-up.

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