How do I set up a (local) lab data table?

Available with version 4.10.0.

Learn how to configure and use Climedo’s Lab Data feature to streamline laboratory value collection across study sites.

TABLE OF CONTENTS

• 1. How to set up lab data collection
  • 1.1 Setup lab parameters and subject-specific variables
  • 1.2 Configuring the lab data table
  • 1.3 Adding the lab data form to your workflow
  • 1.4 Setting validations and automated queries for lab references
  • 1.5 Creating labs and their reference lists
• 2. Managing labs and amending lab data tables and reference lists
  • 2.1 Managing labs in active studies
  • 2.2 Sandbox behaviour
  • 2.3 Managing lab parameters and subject variables
  • 2.4 Replacing reference lists for labs
• 3. Available management rights for configuration
• 4. Duplicating and activating a study that uses the lab data module

This feature allows you to define lab parameters centrally, set up site- or lab-specific units and reference ranges, and validate entered values. It ensures consistent and compliant handling of laboratory data across multi-site studies.

1. How to set up lab data collection

To use the Lab Data module, you must first define the lab parameters and subject variables in Step 2. Afterwards, a Lab Data Table needs to be set up in the form builder (Step 3) to collect the data. In addition, reference lists (including units and reference ranges, if applicable) must be uploaded for each lab that has been created.

1.1 Setup lab parameters and subject-specific variables

Navigate in the Study Settings to Labs → Lab parameters and subject variables (Step 2).

	Defining Lab Parameters: Add the parameters that should be collected in the study (e.g. Hemoglobin, Cholesterol). Parameters should reflect all lab values required by the protocol. Only parameters defined here will be available later in the Lab Data Table (Step 3). ⭐ Good to know: Parameters cannot be added directly from the data entry table — they must first be set up in this central parameter list.
	Adding Subject Variables (optional): Subject variables (e.g. sex, age group) can be linked to lab parameters if reference ranges depend on them. These variables can be used for all or only selected parameters and labs. A variable should only be selected if at least one of the listed parameter depends on it. Setup: Select from already existing form fields in the study (e.g. Demographics form). In this example, we have selected "Gender" as the reference variable, as the reference ranges for "Hemoglobin" will depend on it. ⚠️ Important: Subject variables must be available in the study before they can be linked here. Selection is only needed if at least one lab parameter depends on it.
	Save the configuration. To proceed with the configuration, navigate to Step 3 - Scheduled Event Forms.

For more details on managing lab parameters and subject variables throughout a study, refer to 2.3 Managing lab parameters and subject variables.

1.2 Configuring the lab data table

Navigate in the Study Settings to Forms → Scheduled Event Forms (Step 3) and open/create a form for lab data collection.

	Set up the Lab Data Table. Select the 'Table Field' input type and drag it onto the form.
	In the table field configuration popup, set the flag "Lab data" to active. A lab data table is a version of a table with pre-defined rows, which are in this case the lab parameters. ⚠️ Important: The lab data option is available for the table type "Table (one field per column)".
	Select which defined lab parameters should appear as pre-defined rows. All defined parameters appear by default. Here you have the option to re-arrange their order or remove some if not needed. The table structure is fixed based on lab parameter list configuration in Step 2; new rows cannot be added ad hoc.
	There are four columns added by default: Result, Unit, Lower Limit and Upper Limit. Where the latter three have limited advanced setting options to ensure correct matching with reference files that will be uploaded at a later stage (see 1.5 Creating labs and their reference lists). However, it is possible to update their order as well as display and export label to adapt to your study wording. These three columns Unit, Lower Limit and Upper Limit will be pre-filled based on the uploaded reference lists. It is possible to add additional columns to the lab data table.
	Save your configuration.
	In the form preview, you can view the configured lab data table. The system automatically indicates the 'Unit', 'Lower Limit' and 'Upper Limit' columns as "Prefilled" and does not allow manual data entry.

1.3 Adding the lab data form to your workflow

In Step 4 -> Workflows -> Scheduled Events, add the form with your lab data table to the workflow.

1.4 Setting validations and automated queries for lab references

Validations and automated queries help ensure the accuracy of collected lab data by comparing entered results against the uploaded reference ranges. For each lab data table, you can configure conditions such as "result is smaller than lower limit" OR "result is bigger than upper limit". When triggered, the system automatically displays a message to the site user, prompting them to double-check the value. This reduces manual monitoring effort and improves data quality from the start.

See the Validation / Automated Queries configuration here: How do I create validations – within the trigger events of my study? (Step 5) and How do I set up automated queries in my study? (Step 5)

1.5 Creating labs and their reference lists

Navigate to Step 2 -> Labs -> Lab Overview to create and manage labs.

	In the lab overview click "Create new lab" to open the lab configuration pop-up. From the lab overview, you can access and delete any existing labs at any time.
	In the lab configuration popup enter the required Lab Name and Lab ID. You can also add a description of the lab if you wish.
	In "Site(s) using this lab", select one or more sites served by this lab. ⭐ Good to know: A site can be linked to multiple labs (e.g., a central lab and a local hospital lab). However, each lab parameter at that site should be assigned to only one lab. In other words, the same parameter must not be provided by more than one lab at the same site, to avoid conflicts and duplicate data. ⚠️ Important: The selected lab at the time of data entry determines the prefilled units and reference ranges, which may provide input for optional validations.
	Download the provided reference list template (Excel file) and use it as the basis for configuring each lab. We strongly recommend working with this template, as it is aligned with previously defined parameters and ensures a consistent structure across all labs.
	Fill out the template for each lab: Lab_Parameter: Enter the parameter exactly as it appears in the central parameter list from Step 2 and in the local lab data table in Step 3. The spelling must match precisely. Subject-specific variable(here: Gender): If the parameter depends on a subject variable, enter the corresponding value (e.g., "female" / "male"). For each answer option, repeat the parameter row (e.g., "Hemoglobin (Hb)" twice - once for female, once for male). If the parameter does not depend on a subject variable, leave this cell empty. Unit: Enter the unit used by the respective lab. Lower_Limit: Enter the lab's lower limit for the parameter (adjusted for subject-specific variables if applicable). If no lower limit exists, leave the cell empty. Upper_Limit: Enter the lab's upper limit for the parameter. If not applicable, leave empty. ⚠️ Important:  Do not change the column headers. Do not add, delete, or reorder columns. It is recommended to include all lab parameters that you configured in your Lab Data Table (Step 3). Ensure to enter numeric values for Lower_Limit and Upper_Limit. Only upload finalized reference lists per lab. Draft or incomplete files should not be used. Each list must be set up carefully: either fill in values or leave the cell empty. Once a reference list is uploaded, the corresponding columns (Unit, Lower Limit, Upper Limit) will be pre-filled for enrolled subjects.
	Once you have configured and saved the reference file for a lab, click "Upload Lab References" and select the file to import it into Climedo. After upload, the file is stored under the respective lab and can be viewed, downloaded again, or removed (if applicable) at any time.
	Save the lab configuration.

2. Managing labs and amending lab data tables and reference lists

2.1 Managing labs in active studies

In active studies, you can always create new labs, edit existing labs, or delete them. Site assignments can also be managed at any time. These changes do not affect already collected data.

Reference lists for each lab can also be uploaded, replaced, or deleted directly in the active study. Once uploaded, a reference file is stored per lab and can be downloaded at any time. Completed studies follow the same rules, but no further data collection will take place there.

Lab parameters and subject-specific variables, however, cannot be changed in active studies. They are amendment-related settings and can only be updated through the sandbox.

2.2 Sandbox behaviour

All amendment-related settings are locked in the active study. This means that parameters and subject-specific variables can only be added or updated inside the sandbox.

Lab management is different: labs and their reference lists cannot be edited in the sandbox. You can open a lab in the sandbox to view its setup and download the current reference file, but creating, editing, or deleting labs is not possible. Uploading or replacing reference lists is also not possible in the sandbox.

⭐ In short: use the sandbox for structural changes to lab parameters and subject-specific variables. Use the active study for operational tasks such as creating labs, assigning sites, or maintaining reference lists.

2.3 Managing lab parameters and subject variables

• Parameters and subject-specific variables are amendment-related settings. They can only be added or updated in the sandbox once a study was set to "Active".

• Once a lab data table exists in Step 3 or a reference list is uploaded, parameters can no longer be removed or updated. To make such changes, you must first delete all uploaded reference lists and remove the lab data table, then reconfigure and re-upload.

• Variables can always be added. Once a variable is added, it appears as a new column in the template. If reference lists are already uploaded, the new column will appear empty in downloaded files.

• Variables cannot be removed or updated once reference lists are uploaded. To change them, all uploaded reference lists must be deleted first.

• Input fields used as subject variables cannot be removed or edited in Step 3/4. Their option values and export labels are locked once they are linked to lab references.

2.4 Replacing reference lists for labs

Once an initial reference list has been uploaded and saved for a lab, the option to replace it becomes available. Select the new reference file for this lab, upload, and save it. After saving, the linked Lab Data Table in Step 3 as well as any configured validations in Step 5 will automatically apply the updated units and reference ranges for all newly entered lab data.

⚠️ Please note: Existing entries in scheduled events will not be updated. This means that reference values may differ between subjects, or even within a subject over time, if a replacement is performed for that lab.

3. Available management rights for configuration

To view all relevant management rights for this module, see the "Labs" section of the following article: All Climedo management rights and their explanation.

4. Duplicating and activating a study that uses the lab data module

When you duplicate a study or activate it via the study cards, any lab parameters and subject variables that were configured in the original study are automatically copied to the new version. This ensures that existing lab data tables continue to work without interruption. You can then decide whether or not to also copy the labs and their uploaded reference lists. If you choose to copy them, all labs and reference lists will be cloned so that lab data tables are immediately ready to use in the duplicated or activated study. If you prefer a clean setup, you can leave this option off and create labs and upload reference lists later in the active study.