Pinpoint Data Quality Issues with CluePoints' Data Quality Oversight

CluePoints’ Data Quality Oversight efficiently identifies atypical centres, countries, regions and patients. Clinical and operational data are comprehensively analyzed to ensure that submissions to Regulatory Authorities are of the appropriate quality and integrity. If anomalies are evident then the approach affords sponsors with the ultimate risk mitigation tool to enable Risk-Based Study Execution (RBx).

Compliance with ICH E6 (R2)

The requirements of ICH E6 R2 sum up perfectly what CluePoints has been designed to achieve through its unique statistical approach:

“Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to:

(a) identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations.
(b) examine data trends such as the range, consistency, and variability of data within and across sites.
(c) evaluate for systematic or significant errors in data collection and reporting at a site or across sites; or potential data manipulation or data integrity problems.
(d) analyze site characteristics and performance metrics.
(e) select sites and/or processes for targeted on-site monitoring”

CRO Oversight

ICH E6 (R2) states that “the sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).”

Through the approach of leaving no stone unturned in analysing all clinical data on a regular basis, CluePoints gives sponsors the ultimate method of ensuring oversight no matter who is managing the trial.

Introduce Key Risk Indicators

Revise or introduce new Key Risk Indicators (KRIs) based on the output of the Data Quality Assessment

Identify Discrepancies

Identify any discrepancies across primary endpoint and safety data with extreme data scores to focus on areas that matter most in the study

Define and Analyze Critical Domains

Define critical domains within studies, such as safety data or primary/secondary endpoints, with a view to analyzing only the data that matter. Analyzing every variable relevant to the critical elements allows users to surface significant anomalies across sites.

Investigate Outliers

Enable Clinical Operations staff or Data Managers to easily drill down into outliers and determine any corrective action required

Enable Operational Workflows

Enable operational workflow using the in-built Issue Tracking Management System. All risks and actions are fully documented and can be exported for inclusion with regulatory submissions to prove compliance with ICH E6 (R2).

Compliance with ICH E6 (R2)

The requirements of ICH E6 R2 sum up perfectly what CluePoints has been designed to achieve through its unique statistical approach:

“Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to:

(a) identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations.
(b) examine data trends such as the range, consistency, and variability of data within and across sites.
(c) evaluate for systematic or significant errors in data collection and reporting at a site or across sites; or potential data manipulation or data integrity problems.
(d) analyze site characteristics and performance metrics.
(e) select sites and/or processes for targeted on-site monitoring”

CRO Oversight

ICH E6 (R2) states that “the sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).”

Through the approach of leaving no stone unturned in analysing all clinical data on a regular basis, CluePoints gives sponsors the ultimate method of ensuring oversight no matter who is managing the trial.

Introduce Key Risk Indicators

Revise or introduce new Key Risk Indicators (KRIs) based on the output of the Data Quality Assessment

Identify Discrepancies

Identify any discrepancies across primary endpoint and safety data with extreme data scores to focus on areas that matter most in the study

Define and Analyze Critical Domains

Define critical domains within studies, such as safety data or primary/secondary endpoints, with a view to analyzing only the data that matter. Analyzing every variable relevant to the critical elements allows users to surface significant anomalies across sites.

Investigate Outliers

Enable Clinical Operations staff or Data Managers to easily drill down into outliers and determine any corrective action required

Enable Operational Workflows

Enable operational workflow using the in-built Issue Tracking Management System. All risks and actions are fully documented and can be exported for inclusion with regulatory submissions to prove compliance with ICH E6 (R2).