Using Batch Results for Stability Timepoint 0

If configured by an Admin, Lab Analysts can reuse Lab Test Results from a Batch Release Test for the Initial Timepoint (T0) Study Results of a Stability Study. This saves time and effort, preventing the analyst from needing to manually enter Lab Test Results that have already been entered elsewhere.

The action is unavailable if any of the following conditions are met:

• The Lab Test Results have no associated batch or the batch has no approved Batch Release Spec Execution
• The Lab Study has more or less than one Initial Timepoint
• The Lab Study has already been initiated
• The Stability Spec Data has no Test Actions
• The Stability Spec Data has at least one Out of Specification criteria

When the analyst performs the Initiate Lab Study from Batch action, the system finds valid and completed Batch Tests, regardless of version or variation, that are potential matches for the Lab Study being initiated and displays them in the Initiate from Batch panel. Each potential match is displayed in its own tab on the left of the panel for the analyst to view and assign to each T0 Spec Data test action that has an Out of Specification criteria.

Matches are determined based on the Spec Data Criteria on the Stability Spec Data. A Batch Test is considered a potential match for a Test Action on the Stability Spec Data if it has a Lab Test Result for each Lab Test Result Definition referenced by any such relevant Criteria for that Test Action. Potential matches are categorized into the following types:

• New Test: This means that there are no Tests in the linked Batch that match the Test Action’s Criteria and thus a new Test will be generated in the Initial Timepoint’s Spec Execution. If all potential matches fall into this category, the action proceeds like the standard Initiate Lab Study action.
• Auto Match: The Number of Tests field and Select Count on the Select action are both one, meaning that the Test Action would have exactly one Test generated for it during Spec Execution. Additionally, there is exactly one Test in the Batch’s Spec Execution(s) that matches the Criteria for the Test Action and the Test cannot match with any other Test Action’s Criteria. The system automatically matches Tests that fall into this category with the Test Action.
• Match Available: The Test Action is neither a New Test or an Auto Match, necessitating a decision to be made by the analyst. Generally, this occurs in one of the following scenarios:
  • Multiple Tests exist in the Batch’s Spec Execution(s) that match the Criteria for the Test Action.
  • There is exactly one matching Test in the Batch, but that Test is also a potential match with another Test Action’s Criteria.
  • The Test Action would have multiple Tests generated for it. In this case, even if the number of potentially-matching Tests in the Batch is equal to the number of Tests to be generated for the Test Action, the analyst must match them manually.

How to Use Batch Results for Stability Timepoint 0

In order to reuse Batch Results for a Stability Study’s Timepoint 0:

1. Navigate to the Stability Spec Execution record for the Lab Study to be initiated.
2. Select Actions > Initiate Lab Study from Batch.
3. In the resulting dialog, review the Tests listed along the left side. Tests that are matched display a icon and Tests that require decisions to be made display .
4. For each Test that requires a decision, select the Batch Result to be matched, then click Next. You can also select Generate New Test to use none of the listed Batch Results.
   1. The dialog displays Test Name, Lab Sample, and Sample Type columns followed by columns for each result including the Stability Test’s Criteria to evaluate against. You can sort these results by Test Name, Lab Sample, and Sample Type as well as filter them by Lab Sample and Sample Type.
5. Once you have reviewed each Test and made any necessary decisions, review the summary and click Confirm.

If two Tests have results that are dependent on each other, for example, one test has a result that is used as a cross-test variable in another test, the dependent tests must either all be matched, or none matched.

After matching is complete, if every Test is either an Auto Match or one for which you manually chose a match, the Spec Execution moves to Testing Complete. The criteria for any Test Result values used are evaluated. If any new Tests were generated, the Spec Execution moves to In Progress and you can enter the results as normal.

The system creates as few Lab Samples as necessary. It only creates those directly related to the T0 Test Action. Any planned parent samples or aliquots, for example, are not created.

The system also creates any dependent Tests of the Tests generated (such as those used in cross-test variables) regardless of whether they have any Out of Specification criteria, as they are needed to complete the dependent tests. When determining dependencies, the system ignores Sample scope variables.

During this process, the system ignores Auto-Generate and Auto-Match flags as well as the Prevent Sample Creation flag.

You cannot approve a Stability Spec Execution before approving the Batch Release Spec Execution from which it uses results. Additionally, you cannot re-open a Batch Release Test that has results being used in a Stability Spec Execution without first re-opening the Stability Spec Execution.

Limitations

When performing the Initiate Lab Study from Batch action, the following limitations apply:

• The T0 Spec Data cannot exceed 50 Spec Data Test Actions of object type spec_data_test_sample__v.
• The T0 Spec Data cannot exceed 100 defined Criteria Evaluations.
• The Batch cannot exceed 300 Tests.
• The Batch cannot exceed 1000 Test Results.

Related Permissions

In order to use Batch Results for Stability Timepoint Zero, you must have the LIMS User permission set and Execute permission for the Initiate Lab Study from Batch action.