Migrating Lab Data

EDC Migrator supports the migration of lab data.

Managing Lab Settings

Before initiating your lab data migration, set Enable Pending Lab Locations to No by navigating to Labs > System General Settings.

Preparing Lab Data

Prepare your lab data for migration by checking your Labs and Demographics source files. The following header fields must be present:

Labs File:

• Collection DateTime
• Lab Location

Demographics File:

• Age

The Sex field is optional and does not have to be present in the source file. In the YAML file, Lab Location is mapped to the Item Definition’s external ID.

Collection DateTime

The Migrator maps the Collection DateTime field to the Item Definition’s external ID. You can use derived columns to create separate date and time fields from your source file. This arrangement supports the typical representation of lab data, where each Form row corresponds with one item. EDC only accepts time in the dd-MMM-yyyy HH:mm format.

The system records errors in the Log Fileunder the following conditions:

• The datetime is marked as Intentionally Left Blank (ILB) in the Attributes CSV file.
• The date is present, but the time is missing.
• An unknown value is present when it shouldn’t be.

The Migrations Report does not record these errors.

The Migrator validates the Collection DateTime field based on the following lab collection time configurations:

Configuration	Description
Required	The Migrator validates that both the date and time are present and in the correct format.
Allow Unknown	The Migrator validates that the date is present and applies a transformer if the time is missing. If the date is missing, an error occurs.
Always Unknown	The Migrator only validates that the date is present. An error occurs if a time value is present.

Fasting Status & Female Cycle

You can migrate lab data with the Fasting Status and Female Cycle fields. The Migrator validates these fields by comparing your source data against system-generated codelists. An error will occur if a value doesn’t match the following predefined options:

• Fasting Status:
  • Y - Yes
  • N - No
  • U - Unknown
• Female Cycle:
  • Follicular
  • Mid-Cycle
  • Luteal
  • Post-menopausal
  • Pregnancy

Sex & Date of Birth

The subject’s sex is initially taken from the Gender field in the Demographics form within the EDC casebook variable. The sex value must match the approved codelist. If the sex value is missing, an error occurs. This also applies to the date of birth, which is obtained from the Demographics form within the EDC casebook variable.

Lab Data Migration

During the Run step, the system displays the number of created lab panels in the Item Group count found on the Load Results - Summary page.

During the Post-Run step, the system links lab data to queries and updates the Queries count in the Post-Run Summary table. Queries are obtained from the Queries CSV file.

The system also applies attributes to lab data using the Attributes CSV file. It identifies analyte in the ITEM column and their related Item Definitions in the ITEM_VALUE column. Both ITEM and ITEM_VALUE are required to apply attributes. If either field is missing, the system generates an error. The Attribute count in the Post-Run Summary table displays the applied attributes.