Subject dataset

You can use the Subject dataset to analyze and visualize subject level details and the audit history of a subject's data.

Modes

Available in all 3 modes: Testing, Training, and Production

What type of data can I include in a custom report or visualization on subject data?

With this dataset, you can find information such as:

  • The number of subjects that have been screened at a specific site
  • All subjects over 60 that have been screened failed
  • All the reasons why subjects have failed screening at a specific site
  • The number of subjects that have been randomized in a selected country

For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.

Browse descriptions of data elements included in this dataset:

Note:

Blank columns in Oracle Clinical One Analytics indicate null or not applicable.

Tip:

In order for Oracle Clinical One Analytics to perform optimally, begin by adding data elements from the Required folder to your workbook. For more information, see Create and edit a data visualization.

Parent topic: Dataset descriptions

Study folder

This table describes the data elements included in the Study folder

Table 3-54 Data elements in the Study folder

Data element Description
STUDY_MODE
Indicates the study mode used in the referencing data in a custom report. Values can be:
  • Testing
  • Training
  • Active
STUDY_ID_NAME

The study ID as specified when the study was created. The study ID typically includes the protocol acronym or protocol number and must be unique within a tenant.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

STUDY_TITLE

The Study Title as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

STUDY_REFNAME

Indicates the study's reference name used by the system.

This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed.
STUDY_PHASE

The study phase as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The study phase is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.studyPhase codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

THERAPEUTIC_AREA

Indicates the therapeutic area as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The therapeutic area is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.therapeuticArea codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

BLINDING_TYPE

Indicates the blinding type of the study (whether the study is open-label or blinded) as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The blinding type is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.openLableBlinded codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

STUDY_VERSION

Indicates the study version of the referencing data in a custom report.

The study version is associated to a subject and corresponds to that on which a subject was added to the study. This value does not change for a subject, regardless of the creation of new study versions for a given mode.
STUDY_SERIAL_NUMBER

For Oracle use only.

Internal Clinical One study identifier.

Parent topic: Subject dataset

Site folder

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

Note:

A site may have multiple addresses added that are used for different purposes (primary address, shipping address, billing address, alternate address), but only one address can and must be configured as the main primary address.
  • Only a site's main primary address is transmitted to Oracle Clinical One Analytics for the address data elements (those starting with ADDRESS_).
  • The shipping address data elements (those staring with SHIPPING_) return the site's shipping address details only if added in Clinical One Cloud Service, otherwise it will return null.

    If a site has multiple shipping addresses, only the first entered shipping address is transmitted to Oracle Clinical One Analytics.

Table 3-55 Data elements in the site folder

Data element Description
ADD_SUBJECTS
Setting defined at the study site level to allow site users to add subjects. Values can be:
  • true
  • false
ADDRESS_CITY

The city of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_COUNTRY

The country of the site's main primary address, as entered when the site was created or last modified.

This field displays the country's two-digit ISO code.
ADDRESS_POSTALCODE

The zip postal code of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STATE_OR_PROV_OR_CNTY

The state, province or county of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STREET_1

The first line of the site's main primary address, as entered in the Address Line 1 field when the site was created or last modified.
ADDRESS_STREET_2

The second line of the site's main primary address, as entered in the Address Line 2 field when the site was created or last modified.
DEA_NUMBER

The DEA registration number of the site's contact.
DISPENSE_TO_SUBJECTS
Setting defined at the study site level to allow site users to dispense kits to subjects. Values can be:
  • true
  • false
DRUG_DESTRUCTION_CAPABLE
Indicates if the site has drug destruction capabilities. Values can be:
  • true
  • false
EMAIL

The email address associated to the site's main primary address, as entered when the site was created or last modified.
EXPIRATION

The expiration date of the DEA registration number of the site's contact.
FAX

The fax number associated to the site's main primary address, as entered when the site was created or last modified.
INITIAL_SUBJECTS_COUNT

Total count of initial subjects in a site that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
INITIAL_SUBJECTS_SDV_TYPE
Type of Source Data Verification (SDV) applied to initial subjects, as defined in the SDV strategy. Values can be:
  • All Questions: meaning all questions must be verified for the subject.
  • Critical Questions Only: meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
PHONE

The phone number associated to the site's main primary address, as entered when the site was created or last modified.
PI_PREFIX
Indicates the prefix for the site's principal investigator. Values can be:
  • First Liutenant
  • Admiral
  • Attorney
  • Brother
  • Captain
  • Chief
  • Commander
  • Colonel
  • University Dean
  • Doctor
  • Elder
  • Father
  • General
  • Fees
  • Honorable
  • Liutenant Colonel
  • Major
  • Major/Master Sergeant
  • Mister
  • Married Woman
  • Single or Married Woman
  • Prince
  • Professor
  • Rabbi
  • Reverend
  • Sister
RANDOMIZE_SUBJECTS
Setting defined at the study site level to allow site users to randomize subjects. Values can be:
  • true
  • false
REMAINING_SUBJECTS_PERCENTAGE

Percentage of remaining subjects in a site, after the initial subjects, that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
REMAINING_SUBJECTS_SDV_TYPE
Type of Source Data Verification (SDV) applied to the remaining subjects, as defined in the SDV strategy. Values can be:
  • All Questions: meaning all questions must be verified for the subject.
  • Critical Questions Only: meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
SCREEN_SUBJECTS
Setting defined at the study site level to allow site users to screen subjects. Values can be:
  • true
  • false
SDV_GROUP_NAME

Name of the SDV strategy that is associated with the site. This name is entered by the user when creating an SDV strategy.
SHIPPING_ADDRESS_1

The first line of the site's shipping address, as entered in the Address Line 1 field when the site was created or last modified.
SHIPPING_ADDRESS_2

The second line of the site's shipping address, as entered in the Address Line 2 field when the site was created or last modified.
SHIPPING_ATTENTION

Indicates the name of the person who will receive shipments at the site, as specified when the site was created or last modified.
SHIPPING_CITY

The city of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_COUNTRY

The country of the site's shipping address, as entered when the site was created or last modified. This field displays the country's two-digit ISO code.
SHIPPING_EMAIL

The email address associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_FAX

The fax number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_PHONE

The phone number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_STATE_OR_PROV_OR_CNTY

The state, province, or county of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_ZIP

The zip postal code of the site's shipping address, as entered when the site was created or last modified.
SITE_ID_NAME

The site ID, as entered when the site was created or last modified.
SITE_STATUS
Indicates the status of the site within the study. Values can be:
  • New: the site is new within the study.
  • Active: the site is currently active within the study.
  • Retired: the site is no longer active in the study.
SITE_STUDY_VERSION

The latest study version associated with the site. This is defined in the Sites & Labs tab of the study's settings.
TIMEZONE

Indicates the time zone for the site, as specified when the site was created or last modified.

Values can be, for example, EST5EDT or America/New_York. Depends on the selected value in Clinical One Cloud Service.

INVESTIGATOR

Last name of the principal investigator associated with the site.
SITE_NAME

Name of the site, as entered when the site was created or last modified.
SITE_SERIAL_NUMBER

For Oracle use only.

Internal Clinical One site identifier.
FROM_SITE_NAME

If a subject is transferred, this field is populated with the site the subject was transferred from.
SITE_TYPE
Indicates the type of organization. Values can be:
  • Site
  • Depot
EHR_ENABLED
Indicates if a site is currently enabled for Electronic Health Record (EHR) data import.
  • Displays Y (yes) for sites currently enabled for EHR data import.
  • Displays N (no) if EHR has never been enabled for a site or if a site was disabled for EHR.

Parent topic: Subject dataset

Country folder

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

Table 3-56 Data elements in the Country folder

Data element Description
COUNTRY_NAME

The country of the site's main primary address, as entered when the site was created or last modified.

This field displays the country's two-digit ISO code.

Parent topic: Subject dataset

Subject (Required) folder

This table describes data elements in the Subject (Required) folder.

Table 3-57 Data elements in the Subject folder

Data element Description
CODE_BREAK Indicates if a subject went through a Code Break event.
DOB

Indicates the subject's date of birth.

Currently, this is a placeholder column that does not contain any data. This column is planned for a future release.
EHR_LINK_STATUS Indicates if a subject is currently linked for Electronic Health Record (EHR) data import. This data element displays:
  • Y for yes.
  • N for no.
ENROLLMENT_DATE Indicates the date when a subject got enrolled in a study. This is the date when the state became Enrolled for a subject.
ENROLLMENT_FAILURE

Indicates whether a subject could not be enrolled in the study.

Currently, this is a placeholder that does not contain any data. This data element is planned for a future release.
ENROLLMENT_OVERRIDE

Indicates a subject's enrollment override.

Currently, this is a placeholder that does not contain any data. This data element is planned for a future release.
EXTERNAL_SOURCE_STATUS_DATE Indicates the date on which the subject status was updated by an external source.
GENDER

The selected gender a subject identifies as.

Currently, this is a placeholder that does not contain any data. This data element is planned for a future release.
INFORMED_CONSENT_DATE

The date on which the informed consent was signed by the subject.

Currently, this is a placeholder that does not contain any data. This data element is planned for a future release.
OLD_SUBJECT_NUMBER A subject's previously assigned number in the system for a transferred subject.
PREVIOUS_SUBJECT_NUMBER When a subject number change is applied, this field holds the number that was assigned to the subject before the change.
RESCREEN_INSTANCE_NUM Instance number of the re-screening event for the subject. If this is the second time a subject is re-screened, the instance number would be 2.
SCREEN_FAILURE_COMMENT Comment added by the site user for a subject's screen failure event.
SCREEN_FAILURE_DATE The date and time when the subject failed screening.
SCREENING_DATE Date of the subject's initial screening visit.
SCREENING_FAILURE Indicates the reason provided by the site user for the subject's screen failure.

The reason to screen fail is specified by selecting an option from a drop-down list of options, which is populated with the labels from the ScreenFailureReason codelist within the system codelist selected for the study.

Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

SCREENING_NUMBER Always displays the original screening number, assigned to the subject at screening.
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.
  • Complete: The subject completed the study.
  • Withdrawn: The subject was withdrawn from the study.
STATE_DATE The date and time when the subject entered a given state.
STUDY_COMPLETION_DATE The date and time when the subject completed the study.
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.
WITHDRAWAL_COMMENT Comment added by the site user for the subject's withdrawal event.
WITHDRAWAL_DATE The date and time when the subject was withdrawn from the study.
WITHDRAWAL_REASON The reason provided for a subject's withdrawal from the study.

The reason to withdraw from the study is specified by selecting an option from a drop-down list of options, which is populated with the labels from the WithdrawReason codelist within the system codelist selected for the study.

Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

Parent topic: Subject dataset

Event folder

This table describes data elements in the Events folder.

Table 3-58 Data elements in the Event folder

Data element Description
EVENT_TYPE Displays the type of event that impacts a subject or its state. Upon selecting this data element, only events that occurred in your study are displayed. This data element displays any of the following subject events:
  • New
  • Screened
  • Withdrawn
  • Undo_Withdrawn
  • Transferred
  • Screen_Failed
  • Screen_Fail_Update
  • Code_Break
  • Complete
  • Undo_Complete
  • Undo_ScrFailed
  • SubjectNumberChanged
  • WithdrawalUpdate
  • Enrolled
  • Undo_Enrolled
  • SubjectPatientLinkCreated
  • SubjectPatientLinkRemoved
  • Randomized
  • ScreenUpdate
  • SubjectNumberReplaced
  • CompletionUpdate
  • EnrollUpdate

Parent topic: Subject dataset

Audit folder

Note:

Consider the following notes for the REASON data element:
  • Only the reason specified for a subject's screen failure or withdrawal events is displayed. In Clinical One Cloud Service, you are not required to specify a reason for the subject's study completion, therefore there is no reason to display for this event in the Subjects dataset.
  • While you can see the reason for change that is specified anytime an update occurs for a subject's screen failure, study completion, or withdrawal event, you cannot view any updates to the event's specific reason. For example, if a subject's Reason for Screen Fail is updated in Clinical One Cloud Service, this update is not specified in this dataset.

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

Table 3-59 Data elements in the audit folder

Data element Description
VERSION_START

As this dataset contains past and current records of changes applied to the subject, the version start indicates the date and time when a subject acquired a given state.

To be used in combination with VERSION_END to determine if the record is current or version ended.
VERSION_END

As this dataset contains past and current records of changes applied to the subject, the version end indicates the date and time when a subject changed from the given state to a different one.

If the given subject state is current, then the version end is not defined, and '31/12/3099 12:00:00 a.m.' displays by default.

OPERATION_TYPE Audit trail field that represents the type of operation performed on the record:
  • CREATED: a given action resulted in a new record.
  • MODIFIED: a given action resulted in the update of an existing record.
  • REMOVED: a given action resulted in the data removal for an existing record.
  • CLEARED: a given action resulted in the clearing of data for an existing record.
USER_NAME

Audit trail field that represents the user who performed the action that generated the record.

The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS.

OBJECT_VERSION_NUMBER

Audit trail field that represents a sequential number for records of a same subject.

For example, if a subject is first in a New state and then changes to Screen_Failed:
  1. Is for the OBJECT_VERSION_NUMBER for the subject at state New.
  2. Is for the OBJECT_VERSION_NUMBER for the subject at state Screen_Failed.
REASON Indicates a reason for the applied changes on the record, if applicable. Otherwise this field is blank.

The reason for change is specified by selecting an option from a drop-down list of options, which is populated with the labels from a codelist within the system codelist selected for the study.

Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

COMMENTS This data element may contain Clinical One Cloud Service system-generated values populated by asynchronous event processing, depending on the record type and workflow.

This field is intended for internal system context and should not be relied on for analytic interpretation.
IS_CURRENT Audit trail field to indicate if the record represents current data. Displays:
  • Y for Yes.
  • N for No.
CURRENT_STUDY_ROLE_NAME Specifies of the role of the user who performed the action associated to the given record.

Even if the user's study role changes, this field always shows the current study role of the given user.

Parent topic: Subject dataset

Aggregation

Note:

If a form contains a hidden and required question that wasn’t answered, the form’s status is considered Incomplete and is not counted in the COMPLETED_FORMS data element, despite its status being displayed as Complete in the Clinical One Cloud Service.

This table describes data elements in the Aggregation folder.

Table 3-60 Data elements in the Aggregation folder

Data element Description
COMPLETED_FORMS

Count of completed forms for a subject, irrespective of visit status and form status.

Note: Each instance of a repeating form is counted as one form.
COMPLETED_VISITS

Count of completed visits for a subject.

Note:
  • This count does not include unscheduled visits.
  • When there are incomplete visits, the count is recalculated.
TOTAL_FORMS

The total number of forms across visits in the study version.

Note:
  • A repeating form instance is counted as one form.
  • Forms in unscheduled visits are not included in this count.
TOTAL_FORMS_COMPLETED_VISITS

The total count of completed forms in completed visits.
TOTAL_VISITS

The total number of visits in a study version.

Note: This count does not include unscheduled visits.

Parent topic: Subject dataset

Reference folder

This table describes data elements in the Reference folder.

Note:

Although WID values are unique identifiers at the study level, they may change over product releases and should not be used as identifiers in your reports.
Data element Description

USER_WID

A number that represents the user, as a unique identifier within the study.

SOFTWARE_VERSION_NUMBER

A number that increases incrementally every time a data point is modified.

DH_TIMESTAMP

A timestamp that indicates when the data became available in the dataset.
FROM_SITE_WID A number that represents the site from which a subject was transferred from, as a unique identifier within the study.

SUBJECT_WID

A number that represents the subject, as a unique identifier within the study.
DESCRIPTION This is a placeholder column that does not contain any data.

STUDY_WID

A number that represents the site, as a unique identifier.

SITE_WID

A number that represents the site, as a unique identifier within the study.

COUNT

Represents the count of records in the dataset.

CURRENT_STUDY_ROLE_WID

A number that represents the role of the user who updated the given record, as a unique identifier within the study.

Even if the user study role changes, this field always shows the current study role of the given user.

Parent topic: Subject dataset