Bluefin supports importing participant actuals into your study to augment your existing forecasts with data from your IRT system.
Navigating to the Participant Actuals Import Page
Within a study, click on the dropdown menu highlighted below. Then, click the gear button to the right to "Actuals."
Prepare a CSV to Import Participant Actuals Data
Format your participant actuals data (likely from an RTSM/IRT system). The following table describes the CSV import format that Bluefin supports. An import template is available by clicking the question mark next to the Import CSV button.
Field Name | Required? | Description |
Participant ID | Yes | An unique identifier for the participant. Participants with the same ID will be merged during imports. Participants with an ID not yet in Bluefin will be added. |
Site | Yes | The name of the site the participant was assigned. If the site does not exist in your organization, you will have the chance to create it during import. Note that the site must be linked in the Enrollment Tab of your scenario for the actual participant to be considered. |
Treatment Arm | Yes | The name of the treatment arm the participant was assigned. If the treatment arm doesn't exist in the study, you will have the chance to create it during import. Note that the treatment arm must be linked in the Cohorts Tab of your scenario for the actual participant to be considered. |
Enrollment Date | No | The date the participant was enrolled. This value may be omitted if the participant hasn't been enrolled (e.g. is in screening). |
Treatment End Date | No | The date when treatment ended for the participant. Leave this field blank if the participant is still enrolled in the study. |
Status | No | The current status of the participant. Defaults to SCREENED if omitted. Must be one of (case insensitive):
|
Date of Birth | No | The date the participant was born. This value may be omitted if this information isn't known. This value may be required if "Weight-Based Dosing" is enabled in the Dosing Tab of your scenario - typical for studies involving infants where weight changes are expected. |
Sex | No | The sex of the participant. May be omitted if unknown. Must be one of (case insensitive):
|
Weight (kg) | No | The weight in kilograms (kg) when the participant was enrolled. This value may be required if "Weight-Based Dosing" is enabled in the Dosing Tab of your scenario. |
Body Surface Area (m2) | No | The body surface area in meters squared (m²) of the participant at enrollment. This value may be required if "Surface Area-Based Dosing" is enabled in the Dosing Tab of your scenario. |
Import Participant Actuals Data
Click Import CSV
Select the formatted CSV file with your participant actuals data.
Review and confirm or update the mapping from your CSV file column/header names, and data fields, to what should be used in Bluefin.
Review your data to confirm it is correct before importing.
Click Import.
