Subject Folder

This table describes the data elements included in the Subject folder.

Table 3-80 Data elements in the Subject folder

Data element Description
PREVIOUS_SUBJECT_NUMBER

When a subject number change is applied, this field holds the number that was assigned to the subject before the change. Otherwise, this field is blank.

SUBJECT_NUMBER

The number currently assigned to the subject in the system as its identifier within the study.

Note: NULL is displayed if a subject was removed using the Undo Add Subject feature.

SUBJECT_STATE A subject's state in Clinical One Cloud Service. Values can be:
  • New: The subject was added to the study but has not been screened yet.
  • Screen_Failed: The subject was manually screen failed by a site user.
  • Auto_Screen_Failed: The subject failed the validations required for screening.
  • Screening_initiated: When a subject is Screened , Oracle Clinical One Analytics displays screening_initiated until the next visit is complete and the subject becomes Active.
  • Active: The subject is currently active in an ongoing study. Typically used in studies with randomization for subjects that have been randomized.
  • Enrolled: The subject is enrolled in a study. Typically used for studies without randomization or for subjects enrolled in a rollover study.
  • Complete: The subject completed the study.
  • Withdrawn: The subject was withdrawn from the study.
SCREENING_NUMBER

Always displays the original screening number, assigned to the subject at screening.