Select and set up source assays

Learn how to select and set up source assays for Equivalence margin development documents.

Before you begin

We recommend becoming familiar with the development and verification assay concept of PLA 3.0 before beginning. For details, see the Development and verification assays topic.

About this task

You select source assays by adding a reference from your Equivalence margin development document to the assays in question. The target document (Equivalence margin development) then uses data aggregation to transfer data and results from the source assays. For details on this concept, see the Data aggregation topic.

Procedure

To select your source assays:
  1. In the References editor of your Equivalence margin development document, select Add reference.
  2. In the Document reference dialog, select the documents from which you want to aggregate data.
    Equivalence margin development documents can aggregate data from specific document types only. In this example, you have to select Dose-response analysis documents
  3. Confirm your selection with OK.
To set up your source assays:
  1. By default, PLA 3.0 uses all source assays as development and verification assays, deems all assays as scientifically acceptable and does not declare technical outliers. Use the references table to set up the source assays as you require.
    ColumnSetup
    Development assay To use a source assay as verification assay only, in the Development assay column, select false from the drop-down list.
    Verification assay To use a source assay as development assay only, in the Verification assay column, select false from the drop-down list.
    Scientifically acceptable If you expect an assay to be rejected by the test system, in the Scientifically acceptable column, select false from the drop-down list.
    Technical outlier To declare a source assay as technical outlier, in the Technical outlier column, select false from the drop-down list.
  2. Save the document.

Example

The following image from the 'Equivalence margin development and verification' sample document shows 12 referenced source assays. Documents 3850, 3854, and 3857 are used as verification assays only. In addition, documents 3850 and 3857 are not deemed scientifically acceptable:
Figure 1. Sample setup of source assays for equivalence margin development