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Importing Participant Actuals

Bringing participant actuals into your study through CSV upload.

M
Written by Mark Lopez
Updated over a month ago

Bluefin supports importing participant actuals into your study to augment your existing forecasts with data from your IRT system.

The following table describes the CSV import format that Bluefin supports. Field names are case insensitive and may differ. If the field names differ, manual mapping may be required during import.

Field Name

Required

Description

Sequence ID

Yes

An unique identifier for the participant. Participants with the same sequence ID will be merged during imports.

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 (in screening).

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.

Weight

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.

Status

No

The current status of the participant. Defaults to SCREENED if omitted. Must be one of (case insensitive):

  • ACTIVE

  • SCREENED

  • SCREEN FAIL

  • INACTIVE

  • DISCONTINUED

  • COMPLETED

Body Surface Area

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.

Sex

No

The sex of the participant. May be omitted if unknown. Must be one of (case insensitive):

  • MALE or M

  • FEMALE or F

Treatment End Date

No

The date when treatment ends for the participant. May be omitted if unknown.

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