Data Import Configuration for Data Loader

MedTech companies that process lab samples, such as blood or DNA, for diagnostic purposes, or pharmaceutical companies that develop targeted therapies, use machines that receive samples in such large quantities that they produce a file containing the results of one or more tests. Vault EDC can import the data from those files and automatically enter it into configured Forms and their data collection Items, instead of users needing to manually enter it.

For data loaders to import this data into Vault EDC, a study designer must first create an Data Import Configuration for it. The Data Import Configuration identifies the destination Form and maps the columns in the CSV file to identifiers, such as Subject ID or Site, and data collection Items on the destination Form. When a data loader imports a CSV, they select the Data Import Configuration that Vault uses to process the data during import.

You must create an Data Import Configuration for each Form that you want to load data into. So, if you are loading machine or device data into more than one form, you must create a separate Data Import Configuration in Studio for each Form.

Create a New Data Import Configuration

1. Navigate to Studio > Studies > Data Loader for your Study.
2. Click + New.
3. Enter a Name for your Data Import Configuration. This Name can’t contain any spaces or special characters, except for dashes (-) and underscores (_).
4. Enter a Label for your Data Import Configuration.
5. Optional: Enter a Description.
6. Select the Destination Form. This is the Form that your imported data is loaded into.
7. Select your Column header creation method. See more details below.
   1. Upload file: Upload a CSV file. Vault will take each of the column headers in your CSV and create rows in the mapping table for them. Then, you can map each of those columns to a form item.
   2. Create manually: Create CSV column header mappings in the mapping table. There must be a mapping for each column in your CSV.
8. If you chose Upload file, drag and drop your file into the Drag and Drop area, otherwise click into that area and upload your file.
9. If you chose Create manually, enter your Column Header, then click + Add. Repeat this for each column.You can add up to 100 columns.
10. Create your mappings.
11. Click Save or click Save and Close to save and close the editor.

Column Headers

The primary purpose of the Data Import Configuration is to map CSV column values to an Item on the destination form or the metadata required to identify the destination form.

The following columns are required:

• Site Number: The Site Number (Name) of the subject’s Site.
• Subject ID: The Subject ID (Name) of the Subject.
• Event Group: The Name of the Event Group that contains the Event.
• Event: The Name of the Event (visit) that contains the destination Form.
• Event Date: The date of the Event (visit).
• Data Items: You must have a column for each data Item that you want to enter into the destination form.

There are two methods for column header creation.

You can choose to Upload file, where you can upload an existing CSV file, and Vault will add all of its column headers to the mapping grid.

You can also choose to Create manually. For this method, you manually enter each of your column headers. Enter the header value, then click + Add. Repeat this for each header. Click to remove a header.

Create Mappings

Your mappings identify the source, value, and format for imported values of the destination form’s Items. Vault adds the following items to the mappings table. You can map these to CSV columns (import file), collect the values as a prompt during import, or define a static value to use as the item value.

Import Source

The Import Source defines where the values come from. There are three options:

• Import File: There is a column containing this value in the import file. You can select the column in Import Value.
• Prompt: There is no column containing this value in the import file. Vault will show the data loader a prompt to enter this value when they import the data.
• Static Value: There is no column containing this value in the import file. You provide a static value in the Import Value field, and Vault uses that value to fill this field during import.

Import Value

The Import Value defines what value Vault uses to fill the field during import.

If you chose Import File for Import Source, select the Column that contains this value in your CSV file.

If you chose Static Value for Import Source, select the Value that you want to use in the Import Value field.

If you chose Prompt for Import Source, you can’t select anything in this field, as the data loader will provide the value in a prompt when initiating import.

Import Format

For Event Date and date, time, and datetime Items, where you selected Import File for Import Source, you can select the datetime format for the value in the Import Format field.

Translate Values

For codelist-type Items where you selected Import File for Import Source, you can map Codelist Values to Import Values. Values from the file can be mapped to selections in an EDC codelist for cases where values differ, such as “Yes” and “Y”.

To translate values:

1. Click the Bars in the Translate Values field.
2. Enter an Import Value for each Codelist Value.
3. Click Save.

Available Mappings

The table below lists the available mappings. All mappings are required.

Item Name	Mapping Columns	Notes
Site Number	Import Source Import Value	The Site Number (Name) of the subject’s Site.
Subject ID	Import Source Import Value	The Subject ID (Name) of the Subject.
Event Group	Import Source Import Value	The Name of the Event Group that contains the Event.
Event	Import Source Import Value	The Name of the Event (visit) that contains the destination Form.
Event Date	Import Source Import Value Import Format	The date of the Event (visit).
Data Items	Import Source Import Value Import Format (Date, datetime, and time only) Translate Values (Codelist-type Items only)	Vault creates a row in the mapping grid for each data collection Item on the destination form.

Copy a Data Import Configuration from Another Study

You can copy an Data Import Configuration from another Study that you have access to. This is useful when you use a certain Form across multiple Studies and plan to import data into both.

To copy an Data Import Configuration from another Study:

1. Navigate to Studio > Studies > Data Loader for your Study.
2. Click Copy From Study.
3. Select Create a copy or Use existing to handle duplicates. See details here.
4. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
5. Select a Study Environment to copy from.
6. Search or scroll to locate the Data Import Configuration you want to copy.
7. Select the Event Group you want to copy.
8. Optional: Select the Select all checkbox to select all Data Import Configurations for copying.
9. Click Copy Configurations. Vault begins copying the Data Import Configurations into your Study.
10. Optional: In the Copy from Study dialog:
    • Click View Summary to see a list of the copied forms and the status of the copy.
    • Click View Log to see detailed status information for each object record copied.
11. When finished, click Close. Once you click Close, you can no longer access the summary or log file.

How to Edit a Data Import Configuration

To edit an Data Import Configuration:

1. Navigate to Studio > Studies > Data Loader for your Study.
2. Locate the Data Import Configuration you want to edit in the list.
3. Hover over the definition’s Name to show the Actions menu.
4. From the Actions menu, select Edit.
5. Make your changes.
6. Click Save and Close.

How to Delete a Data Import Configuration

To delete an Data Import Configuration:

1. Navigate to Studio > Studies > Data Loader for your Study.
2. Locate the Data Import Configuration you want to edit in the list.
3. Hover over the definition’s Name to show the Actions menu.
4. From the Actions menu, select Delete.
5. In the confirmation dialog, click Delete.

Deploying to Other Environments

The Enable Data Loader setting is part of the study deployment package, so changes to this setting are included each time you deploy.

Your Data Import Configurations are also included in the package. However, these are considered versionless changes. So, changes to a Data Import Configuration apply automatically once deployed, without the need for an amendment. Consider this when making changes to your Data Import Configurations.