High Number of Sites with Local Lab References Ranges Delay
High Number of Sites with Local Lab References Ranges Delay</h2><table>
<tbody><tr>
<th>Type of indicator</th>
<td>Performance</td>
</tr>
<tr>
<th>Risk Category</th>
<td>Data Collection</td>
</tr>
<tr>
<th>Golden KRI</th>
<td>No</td>
</tr>
<tr>
<th>Therapeutic Area</th>
<td>General</td>
</tr>
<tr>
<th>IF Risk-Event</th>
<td>Sites do not provide local lab reference ranges when required</td>
</tr>
<tr>
<th>DUE TO Risk Causes</th>
<td>Lack of understanding of importance or not requested</td>
</tr>
<tr>
<th>THEN Risk Impact MAY RESULT</th>
<td>Difficulties in interpretation of lab results and potential safety risk to trial participants</td>
</tr>
<tr>
<th>Risk Indicator</th>
<td>Number of Sites with Local Lab References Ranges Delay</td>
</tr>
<tr>
<th>Metric</th>
<td>Number of sites that did not provide local lab ranges <br> </td>
</tr>
<tr>
<th>Unit</th>
<td>Number</td>
</tr>
<tr>
<th>What level should be measured</th>
<td>Study, Country</td>
</tr>
<tr>
<th>Comments</th>
<td>Only calculate in case subject's lab values had been entered and no reference ranges are available</td>
</tr>
<tr>
<th>Purpose</th>
<td>Ensure the availability of reference ranges for laboratory tests, facilitating reliable interpretation and appropriate clinical decision-making.</td>
</tr>
<tr>
<th>Description</th>
<td>This KRI monitors how many sites have not provided lab ranges even though they have lab results.</td>
</tr>
<tr>
<th>Formula</th>
<td><strong>KD COMMENT:</strong> I have put a formula in below for the country and study levels: For each site, determine whether any trial participant lab values have been entered into EDC. For those that have, determine the number that have not entered local lab ranges.</td>
</tr>
<tr>
<th>Suggested Thresholds - High</th>
<td>>0</td>
</tr>
</tbody></table>
High Number of Sites with Local Lab References Ranges Delay
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 lab reference ranges when required |
| DUE TO Risk Causes |
Lack of understanding of importance or not requested |
| THEN Risk Impact MAY RESULT |
Difficulties in interpretation of lab results and potential safety risk to trial participants |
| Risk Indicator |
Local Lab References Ranges Delay |
| Metric |
Number of sites that did not provide local lab ranges
|
| Unit |
Number |
| What level should be measured |
Study, Country, Site |
| Comments |
Only calculate in case subject's lab values had been entered and no reference ranges are available |
| Purpose |
Ensure the availability of reference ranges for laboratory tests, facilitating reliable interpretation and appropriate clinical decision-making.
|
| Description |
This KRI monitors how many sites have not provided lab ranges even though they have lab results. |
| Formula |
Calculate number of sites that have lab test results but have no references provided |
| Suggested Thresholds - High |
>0 |
