Batch Data Imports

TrialKit's ability to import records is a powerful feature that can be used to perform mass updates on records or to import data from external sources.

Examples:

• Continue studies that need to be moved from another platform into TrialKit

• Bulk data from an external source to avoid manual/hand-entry

• Lab values

• Adding study Participants (ePRO studies)

Pre-requisites and Assumptions:

• Access to Imports within the study role security settings

• Before configuring an import, it's important to build the form(s) in TrialKit with the appropriate data fields that you will be mapping the source data to.

Importing data is done from the Import Configurations page found under the Study menu, currently only via the web.

Follow these steps outlined in this table of contents:

Preparing the study database for importing data

To import data, the database needs the destination form(s) where the data will be imported into. It is important to build the form in a way that can hold all the data which is coming from the source file. This section describes how. 

If your forms have already been built - which is commonly the case - and you are simply add data in the study, open the form in the form builder and export an annotated PDF. This will serve as an easy reference when configuring the import. Also, take note of which field on the form is the visit transaction date. Now you are ready to configure the import.

If you are importing new sets of data that the study has not been set up for, follow these steps:

1. Create a new form

2. Insert the necessary field types that correspond with the data formats being imported. For example, a column in the data source that exists as numbers would need a number or text field on the form. 

3. After all needed fields exist to match up with the source data needed, save the form.

4. Set the form up in the study, either as a log form, a scheduled form, or an unscheduled form.

5. Prepare the import source file.

Preparing source data

Before importing data into a study, the source file must be set up in a way that can be read by the system. This is done by arranging data in columns within a spreadsheet.

The file formats that can be imported are CSV and SAS7bdat.

All rows/records in a source file must have data that correspond to the form in TrialKit where it will be imported. One file must correspond to a single form.

Importing must be done one form at a time. However, it's okay if there are extra columns of data that don't apply. These columns simply won't be mapped in the configuration.

Every data file must have a minimum of four columns: Site, Subject, Visit, and Date.

Each of these columns is described below. Note, using these exact column header names is not required.

Site:

Use the site name that corresponds to each record. The site name must match what is found in the Site Manager

Subject:

Each record must have a subject ID that matches the current subjects registered in the study.

Visit:

Each record must have a visit name identified. The visit interval map is where these visit names are defined. It is important to use the same names that are mapped.

If the records being imported are log forms or the subject registration form, the visit can be left blank

Date:

This column is required because every record in TrialKit must have a date. This will be the column that corresponds to the visit transaction date that was set when the form was built.

Lastly, review all other columns in the file to ensure the formats are consistent within each column. These data formats will need to match up with the data field they are being imported into.

Here is an example of a file being used to import Adverse Event records into a study across multiple sites and subjects. The columns described above are highlighted. 

Important Note: If subjects BPA-020 and BPA-02, from the image above, are new subjects that do not already exist in the database, they will need to first be imported before importing this file. Otherwise, select the configuration option to only import existing subjects.

Creating an Import Configuration

Open the Import configuration screen.

Data must be imported into one form at a time. Each form requires its own configuration. 

For example, if importing patient physical exam data, a configuration would be set up to import all physical exam data for all patients and all visits at once.  

All configurations are saved and can be reused in the future without needing to follow these steps.

To create a new configuration, follow the image annotations below:

1.  Map the visit intervals - Be sure the source interval column reflects exactly what the source file contains, and save the interval map. This is only done once but can be changed at any point to match what the source files contain in the visit column. 
   
   

2.  Create a new configuration
   
   

3.  Complete this form

   1. Configuration Name

   2. External Visit Date Import - Used if importing normalized tables where the data is imported into a parent record containing a different date.

   3. Destination Form - Select the form the data will go into. This is the form the source data will be mapped to in a later step.

   4. Form Table - Only if the source data is being imported into a normalized table within a form - select the table name from the destination form. 

4.  Import the source file - This must be in one of the following formats:

   1. CSV

   2. SAS7BDAT

Once the new configuration is saved, another page will open to map the fields. 

Mapping the Import

After creating the initial configuration, it will be saved, and can be accessed in the future, on the right side of the page as highlighted below.

The following descriptions correspond to the image directly below:

1. Import Configuration Basics

Select one or more options on how the import should be run. All imports will be recorded in the corresponding records' audit trails. The options selected below are a common example, where records will be created if they don't exist. Here are some useful notes on this particular configuration:

• If the system finds a record already in place, whatever data is mapped will be overwritten - unless 'Update' is not checked.

• If the source file contains a blank value for a given data point, any existing record data will NOT be overwritten - unless 'Update with null value' is checked.

• Any sites found under the source file's 'Site' column will automatically be created if they don't exist already.

• And subjects found in the Sub ID column will be automatically created.

2. Import control fields

Identify the source file column headers that correspond to: 

• Subject ID - If the subject Id in the source file does not already exist, the system will create that subject and insert a blank registration form.

• Date field - All subject records must have a date/transaction field. If the source data does not contain one, it must be created. Be sure the date field on the form that is defined as the transaction date is what is used here. This helps the system identify unique records, along with the search key in item 3 below.

• Visit Interval - This is what was mapped in the visit interval map on the right side of the page to correspond with the visit column from the source file

• Site Name - If sites already exist in the study, use the same site names in the source file. Otherwise, the system will automatically create a new site.

3. Import search key

Identify which data point(s) the system should use to identify unique records. In most cases, this will be the visit date and visit interval that is defined in the Import control fields from item 2 above. The important thing here is to be sure to identify as many items that are necessary to differentiate a record so the system can determine if it is previously existing or not.

Last, is the mapping of the data fields on the form specified above as the destination form. Map each field from the form in TrialKit to the corresponding column header from the source file. Mapping each field is NOT required. Any item not mapped will simply not be imported. If the data already exists in TrialKit for a specific field and that field is not mapped, the data will be ignored.

Testing and Importing the Data

After configuring the import, open the page titled 'Run Import' located under the Study menu.

1. Choose the configuration you wish to run the import for. The study will save all past configurations, so future imports can easily be run here without needing to re-create the configuration.

2. Upload the same source file used for the configuration mapping.

3. Test the import. This will check for any mapping errors with regard to the current data in the source file

After the test is run, results will be displayed with any errors that were caught based on mapping discrepancies.

If any errors are seen, scroll down the page to reference where the errors were seen. Then return to the Import Configuration to fix the issues, or select to Force Run the Import via the checkbox shown above. Forcing the import will bypass any records where errors were seen. 

Imports run very quickly and a confirmation message will be displayed at the top. Once complete, open the Subject Manager or Data exports to see the data.

Creating Participant Users From Batch Import

During the import test process discussed above, If the study is an ePRO study and the form being imported is the study’s defined Registration form, there will be an option to Create Participant Users:

The system will run the routine checks when creating participant users - Verifying duplicate subject emails, ensuring the user is not already a non-participant user, etc. However, it will NOT process any conditional actions, such as sending participant sign in notifications.

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