Collecting lab data with site-/lab-specific references

Available with version 4.10.0.

Learn how to use lab data tables during data entry — how pre-filled values work, what is saved, and how validations and exports help ensure accuracy.

TABLE OF CONTENTS

• 1. Where to find the lab data table
• 2. Entering lab results in the lab data table
• 3. Reference files and versions
• 4. Exports

Climedo’s lab data tables make it easier for site users to enter lab results in a structured way. Units and reference ranges are pre-filled automatically based on the assigned lab for each site. This reduces manual work, ensures consistency, and supports automatic validations.

1. Where to find the lab data table

Lab Data tables are only available in scheduled event forms where the study team has marked a table as "Lab Data" during setup. They are not shown in (S)AE forms, unscheduled events, or sample forms.

2. Entering lab results in the lab data table

	Prefilling of data: The lab data table automatically prefills the Unit, Lower Limit, and Upper Limit for each parameter based on the reference list of the lab assigned to the subject's site. These values provide context for your data entry and are not editable. If no information is available in the reference list, the field will automatically be marked as unavailable.
	Subject-specific variable dependency of certain parameters: Some parameters may depend on subject-specific variables such as gender or age. Once you select the correct value, the system applies the appropriate reference ranges from the lab’s reference file to the table. In this example "Female" was selected for the subject-specific variable "Gender" in the "Screening" form and was mirrored into this form for context.
	Validations and automated queries (if configured): When you enter a result, the system checks it against the configured reference range. If the value falls outside of the defined limits, a validation message appears and an automated query is raised. These queries are logged and can later be tracked in query management and the subject overview.
	Save data: Click "Save changes" to store your entries. Both your manually entered values and the prefilled context values (unit and reference ranges) are saved together. All actions are reflected in the audit trail, including the user who performed the save and the timestamp.

3. Reference files and versions

When you enter and save lab results, the system always applies the reference file that is currently active. Previously saved data will not change, even if the study team later uploads a new file. As a result, a subject's lab data may be linked to different versions of the reference file if results were entered at different times.

4. Exports

Lab data tables can be exported just like any other table, either in vertical or horizontal format (Excel/CSV). Units and reference ranges will only appear in the export if the data has been saved.