High Percentage of Total Overdue Queries
High Percentage of Total Overdue Queries (kri)
KEITH COMMENT: Really don't like this title. Not sure what the "total" is referring to.
| Type of indicator | Performance |
|---|---|
| Risk Category | Data Collection |
| Golden KRI | Yes |
| Therapeutic Area | General |
| IF Risk-Event | Sites don't respond to queries in timely fashion |
| DUE TO Risk Causes | Not understanding the queries, lack of responsiveness, lack of resource |
| THEN Risk Impact MAY RESULT | A concern for the sites correctly following the protocol/GCP and a potential delay to database lock with lengthened study timelines. |
| Risk Indicator | High percentage open queries overdue for response |
| Metric | Percent of queries responded to in more than XXX days of query being posted |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Comment | Calculate only for opened queries |
| Purpose | To help assess the responsiveness of the site. A high level of overdue queries for the site may be due to poor site responsiveness and might indicate challenges at the site such as resource or training which might impact other aspects of the clinical trial. |
| Description | This KRI monitors the proportion of queries that are overdue for response out of all opened queries |
| Formula | For all opened Queries understand delta between Query Open date and Query Response date, if delta is more than XXX days then consider as Overdue Query. Divide a value of metric Number of Overdue Queries by a value of Number of Open Queries for the same date and multiply by 100%. |
| Suggested Thresholds - High | >10 % |
| Suggested Thresholds - Medium | >5 % |
| Associated Metric 1 | Number of Manual Queries |
| Associated Metric 2 | Number of Automatic Queries |
| Associated Metric 3 | Days to respond to Queries |