Oracle Clinical One Analytics supports replacing a subject number with a randomization number

Replacing a subject number with a randomization number in an Oracle Clinical One Platform study is now supported in Oracle Clinical One Analytics datasets.

Details for Oracle Clinical One Analytics users

The setting, Replace Subject Number with Randomization Number, was introduced in a previous Oracle Clinical One Platform release. When enabled, the randomization number replaces the subject number throughout the study after randomizing a subject.

More information about this setting is available in the Sponsor and CRO User Guide under Specify study, enrollment, and visit settings.

This enhancement impacts the following Oracle Clinical One Analytics datasets, starting with this release:

Blinded Kits dataset
Blinded Subject Event dataset
Queries dataset
Subject dataset
Subject Form Items dataset
Subject Forms dataset
Unblinded Kits dataset
Unblinded Subject Event dataset

Impact to datasets

A new column, SCREENING_NUMBER, is available in the Subject folder for each dataset.

For a new subject, the values displayed under SUBJECT_NUMBER and SCREENING_NUMBER match after you create a subject, as seen in the table below.

Table 2-3 Example dataset output before randomization

SUBJECT_NUMBER	SUBJECT_STATE	PREVIOUS_SUBJECT_NUMBER	SCREENING_NUMBER
001-001	Screened	This cell is initially blank	001-001

If the Replace Subject Number with Randomization number setting is enabled and you randomize a subject:

SUBJECT_NUMBER displays the randomization number.
PREVIOUS_SUBJECT_NUMBER displays the original subject number.
SCREENING_NUMBER remains unchanged, as it always displays the original screening number for a subject.

Table 2-4 Example dataset output after randomization, where 123456 is the randomization number

SUBJECT_NUMBER	SUBJECT_STATE	PREVIOUS_SUBJECT_NUMBER	SCREENING_NUMBER
123456	Active	001-001	001-001

If you re-randomize a subject:

SUBJECT_NUMBER displays the new randomization number.
PREVIOUS_SUBJECT_NUMBER displays the initial randomization number.
SCREENING_NUMBER remains unchanged, as it always displays the original screening number for a subject.

Table 2-5 Example dataset output after re randomization, where 789101 is the new randomization number

SUBJECT_NUMBER	SUBJECT_STATE	PREVIOUS_SUBJECT_NUMBER	SCREENING_NUMBER
789101	Active	123456	001-001

You can find additional information in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade.