Remote clinical study site monitoring and data quality scoring
A method for remote site monitoring includes receiving data from a data site, converting those data into a site-level quality score using a metric risk profile, and calculating a risk indicator based on the site-level quality score. The metric risk profile may be based on historic data and study data, where the study data is received from a plurality of data sites. In some embodiments, converting the data includes normalizing a value of a metric by applying to it the metric risk profile and aggregating the normalized metric values to calculate the site-level quality score. An apparatus for remote site monitoring is also described.
1. A computer-implemented method, comprising:
receiving site data from one or more clinical sites, the site data including clinical monitoring data;
converting, by a processor, the site data into a site-level data quality score using at least one single-sided or double-sided metric risk profile, wherein:
the site-level data quality score is based on at least two metrics; and
the at least one metric risk profile is based on at least clinical study data and historic clinical study data, the clinical study data being received from a plurality of clinical sites and the historic clinical study data having a statistical distribution and a benchmark related to a metric;
calculating a risk indicator based on the site-level data quality score; and
generating, by a processor, the at least one metric risk profile in at least substantially real-time by:
calculating a clinical study benchmark for at least one of the metrics based on the clinical study data;
automatically scaling the historic clinical study data statistical distribution by a ratio of the clinical study benchmark to the historic clinical study data benchmark; and
assigning risk regions, utilizing measures of statistical significance, to the scaled statistical distribution; and
outputting at least one of said risk indicator and said site-level data quality score.
2. The method of claim 1 , further comprising:
receiving site data from a plurality of clinical sites; and
calculating a higher-level data quality score for the plurality of clinical sites.
3. The method of claim 2 , further comprising calculating a second risk indicator based on the higher-level data quality score.
4. The method of claim 2 , wherein the plurality of clinical sites comprise sites having a common element.
5. The method of claim 2 , wherein the plurality of clinical sites comprise sites from a single country.
6. The method of claim 2 , wherein the plurality of clinical sites comprise sites from an entire data study.
7. The method of claim 1 , wherein the converting of the site data comprises:
calculating a plurality of metric values from the site data;
normalizing each metric value by applying to it a corresponding metric risk profile; and
aggregating the normalized metric values to calculate the site-level data quality score.
8. The method of claim 7 , wherein each metric value is weighted based on significance of the metric to the data quality of the clinical site.
9. The method of claim 1 , wherein the risk regions correspond to percentiles of the historic data distribution modified by the ratio.
10. The method of claim 8 , wherein the aggregating comprises combining weighted, normalized metric values.
11. The method of claim 8 , wherein the weighting applied to each metric value is dynamically determined from site-based feedback concerning actual site data quality conditions.
12. An apparatus, comprising:
a site data filter configured to receive site data from one or more clinical sites, the site data including clinical monitoring data;
a processor configured to:
convert the site data into a site-level data quality score using at least one single-sided or double-sided metric risk profile, wherein:
the site-level data quality score is based on at least two metrics; and
the at least one metric risk profile is based on at least clinical study data and historic clinical study data, the clinical study data being received from a plurality of clinical sites and the historic clinical study data having a statistical distribution and a benchmark related to a metric;
calculate a risk indicator based on the site-level data quality score; and
generate the at least one metric risk profile in at least substantially real-time by:
calculating a clinical study benchmark for at least one of the metrics based on the clinical study data;
automatically scaling the historic clinical study data statistical distribution by a ratio of the clinical study benchmark to the historic clinical study data benchmark; and
assigning risk regions, utilizing measures of statistical significance, to the scaled statistical distribution; and
a component configured to output at least one of said risk indicator and said site-level data quality score.
13. The apparatus of claim 12 , wherein:
the site data filter is configured to receive site data from a plurality of clinical sites; and
the processor is configured to calculate a higher-level data quality score for the plurality of clinical sites.
14. The apparatus of claim 13 , wherein the processor is configured to calculate a second risk indicator based on the higher-level data quality score.
15. The apparatus of claim 13 , wherein the plurality of clinical sites comprise sites having a common element.
16. The apparatus of claim 13 , wherein the plurality of clinical sites comprise sites from a single country.
17. The apparatus of claim 13 , wherein the plurality of clinical sites comprise sites from an entire data study.
18. The apparatus of claim 12 , wherein the processor further comprises a site risk profiler configured to calculate the risk indicator based on the site-level data quality score.
19. The apparatus of claim 12 , wherein the processor further comprises:
a site metric processor configured to calculate a plurality of metric values from the site data;
a metric risk profiler configured to normalize each metric value by applying to it a corresponding metric risk profile; and
an aggregator configured to aggregate the normalized metric values to calculate the site-level data quality score.
20. The apparatus of claim 19 , wherein each metric value is weighted based on significance of the metric to the data quality of the clinical site.
21. The apparatus of claim 20 , wherein the aggregating comprises combining weighted, normalized metric values.
22. The apparatus of claim 20 , wherein the weighting applied to each metric value is dynamically determined from site-based feedback concerning actual site data quality conditions.
23. The apparatus of claim 12 , wherein the risk regions correspond to percentiles of the historic data distribution modified by the ratio.
24. A computer readable storage medium, comprising computer executable instructions embodied therein, to be executed by a computer, for:
receiving site data from one or more clinical sites, the site data including clinical monitoring data;
converting, by a processor, the site data into a site-level data quality score using at least one single-sided or double-sided metric risk profile, wherein:
the site-level data quality score is based on at least two metrics; and
the at least one metric risk profile is based on at least clinical study data and historic clinical study data, the clinical study data being received from a plurality of clinical sites and the historic clinical study data having a statistical distribution and a benchmark related to a metric;
calculating a risk indicator based on the site-level data quality score; and
generating, by a processor, the at least one metric risk profile in at least substantially real-time by:
calculating a clinical study benchmark for at least one of the metrics based on the clinical study data;
automatically scaling the historic clinical study data statistical distribution by a ratio of the clinical study benchmark to the historic clinical study data benchmark; and
assigning risk regions, utilizing measures of statistical significance, to the scaled statistical distribution; and
outputting at least one of said risk indicator and said site-level data quality score.
25. The computer readable storage medium of claim 24 , further comprising computer executable instructions embodied therein, to be executed by a computer, for:
receiving site data from a plurality of clinical sites; and
calculating a higher-level data quality score for the plurality of clinical sites.
26. The computer readable storage medium of claim 25 , further comprising computer executable instructions embodied therein, to be executed by a computer, for calculating a second risk indicator based on the higher-level data quality score.
27. The computer readable storage medium of claim 24 , further comprising computer executable instructions embodied therein, to be executed by a computer, for:
calculating a plurality of metric values from the site data;
normalizing each metric value by applying to it a corresponding metric risk profile; and
aggregating the normalized metric values to calculate the site-level data quality score.
28. The computer readable storage medium of claim 27 , wherein each metric value is weighted based on significance of the metric to the data quality of the clinical site.
29. The computer readable storage medium of claim 28 , wherein the weighting applied to each metric value is dynamically determined from site-based feedback concerning actual site data quality conditions.