High Number of Sites with Local Lab References Ranges Delay
| Type of indicator | Performance |
|---|---|
| Risk Category | Data Collection |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | Sites do not provide local laboratory reference ranges when required |
| DUE TO Risk Causes | Lack of awareness of the requirement, insufficient site training, or failure to request ranges from the laboratory |
| THEN Risk Impact MAY RESULT | Difficulties in interpreting laboratory results, delayed data review, and potential safety risks to subjects |
| Risk Indicator | High Number of Sites with Local Lab Reference Ranges Delay |
| Metric | Number of Sites That Did Not Provide Local Lab Reference Ranges |
| Unit | Number |
| What level should be measured | Study, Country |
| Comments | Calculate only when subject laboratory values have been entered and no corresponding reference ranges are available. |
| Purpose | Ensure the timely availability of laboratory reference ranges to support accurate data interpretation, maintain data integrity, and enable appropriate clinical decision-making. |
| Description | This KRI monitors the number of sites that have entered subject laboratory results but have not provided the associated local laboratory reference ranges. It helps identify data gaps that may compromise safety evaluations or study accuracy. |
| Formula | For each site, determine whether any subject laboratory values have been entered into the EDC system. For those sites, count how many have not entered local laboratory reference ranges. Number of Sites with Missing Local Lab Reference Ranges = Total sites with lab data entered but no reference ranges. |
| Suggested Thresholds - High | >0 |
| Associated Metric 1 | Number of Sites with Subject Lab Data Entered but Missing Local Lab Reference Ranges |