Subject Forms dataset
You can use the Subject Forms dataset in Oracle Clinical One Analytics to analyze and visualize audit history of forms attributed to individual subjects. Current and audit form records are included.
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 forms?
With this dataset you can get valuable information, such as:
- How many incomplete forms are there for a specific site, visit, and subject.
- What forms are available for Source Data Verification (SDV) at a particular site (CRA).
- When you should schedule a site visit based on the amount of completed forms there are at a site (CRA).
- The percentage of forms with a status of Incomplete, Completed, Frozen, SDV Complete, Signed or locked by either country, site, subject, and visit.
For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.
Note:
Blank columns in Oracle Clinical One Analytics indicatenull 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.- Study folder
- Site folder
- Country folder
- Subject folder
- Event folder
- Form (Required) folder
- Form Association folder
- Audit folder
- Aggregation folder
- Reference folder
Parent topic: Dataset descriptions
Study folder
This table describes the data elements included in the Study folder
Table 3-69 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:
|
| 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. |
Parent topic: Subject Forms 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 returnnull.If a site has multiple shipping addresses, only the first entered shipping address is transmitted to Oracle Clinical One Analytics.
Table 3-70 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:
|
| 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:
|
| DRUG_DESTRUCTION_CAPABLE |
Indicates if the site has drug destruction capabilities. Values can be:
|
|
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:
|
| 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:
|
| RANDOMIZE_SUBJECTS |
Setting defined at the study site level to allow site users to randomize subjects. Values can be:
|
| 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:
|
| SCREEN_SUBJECTS |
Setting defined at the study site level to allow site users to screen subjects. Values can be:
|
| 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:
|
| 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_TYPE |
Indicates the type of organization. Values can be:
|
| EHR_ENABLED |
Indicates if a site is currently enabled for Electronic Health Record (EHR) data import.
|
Parent topic: Subject Forms dataset
Country folder
This table describes the data elements included in the Country folder.
Table 3-71 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 Forms dataset
Subject folder
This table describes the data elements included in the Subject folder.
Table 3-72 Data elements in the Subject folder
| Data element | Description |
|---|---|
| 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:
|
| PREVIOUS_SUBJECT_NUMBER | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
| SCREENING_NUMBER | Always displays the original screening number, assigned to the subject at screening. |
Parent topic: Subject Forms dataset
Event folder
This table describes the data elements included in the event folder.
Table 3-73 Data elements in the event folder
| Data element | Description |
|---|---|
| EVENT_TITLE | The event's title, defined by the user when an event is created. |
| EVENT_REFNAME |
The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
| EVENT_ID_NAME | The event's id as in Clinical One Cloud Service. |
| VISIT_IS_REQUIRED | Indicates if a visit is required. |
| IS_SCHEDULED_VISIT | Indicates if the visit is scheduled. |
| SCHEDULED_FROM_EVENT_NAME |
Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
| VISIT_STATUS | Indicates a visit's status in the system. Can have one of the following values:
|
| VISIT_START_DATE | Date stamp of a visit's start date. |
| VISIT_TYPE | Displays the type of visit:
|
| EVENT_TYPE |
Displays the type of event that impacts a visit. Upon selecting this data element, only events that occurred in your study are displayed. This data element displays any of the following events:
|
| PROJECTED_VISIT_START_DATE | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
| PROJECTED_VISIT_END_DATE | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
| PROJECTED_VISIT_DATE | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
| DELAY_DAYS | The number of days between the prior scheduled visit. |
| DELAY_HOURS | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
| VISIT_WINDOW_BEFORE_DAYS | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
| VISIT_WINDOW_BEFORE_HOURS | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
| VISIT_WINDOW_AFTER_DAYS | Indicates how many days after the scheduled date and time the visit can occur. |
| VISIT_WINDOW_AFTER_HOURS | Indicates how many hours after the scheduled date and time the visit can occur. |
| EVENT_INSTANCE_NUM | Indicates the unscheduled visit instance number as designed by the study designer. |
| VISIT_ORDER | The order in which subject visits occur, as configured in the study design. |
| SCHEDULED_FROM_EVENT_REFNAME |
Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit’s own refname.. |
Parent topic: Subject Forms dataset
Form (Required) folder
Note:
- If a form contains a hidden and required question that wasn’t answered, the status of the form is considered Incomplete and reflected in the FORM_STATUS data element, despite its status being displayed as Complete in Clinical One Cloud Service.
- For repeating forms, this dataset includes separate records for each section (the whole form and each individual repeating instance), showing the status for the given section. Both current and audit records are included for each.
- As soon as a dynamic form is triggered, it is included in this dataset as a scheduled form.
- All form records display the current status for Signed, Verified, Freeze and Locked (SVFL) actions. If you need to work with the audit history of form SVFL actions, you may use the Subject Form SVFL dataset.
Table 3-74 Data elements in the Form folder
| Data Element | Description |
|---|---|
| FREEZE | Indicates if a form is frozen by a data manager or CRA. |
| VERIFIED |
Indicates the form's verification status. Data element can be populated with the following values:
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. |
| SIGNED | Indicates if a valid casebook signature is applied to the form. |
| FORM_NAME | The name of the form, as specified by the study designer. |
| FORM_REFNAME | A form's reference name. |
| REPEAT_SEQUENCE_NUMBER |
Refers to the row instance number of all applicable form types with repeating data:
|
| FORM_STATUS | The status of the given form. Can have one of the following values:
|
| IS_REPEATING | Indicates if it is a repeating form. |
| IS_ROLLOVER | Indicates whether the form contains a rollover type of question. |
| REPEAT_FORM_NUMBER |
Refers to the form instance number of all applicable form types with repeating data:
|
| INNER_REPEAT |
Refers to the Section Repeat values of all applicable form types with repeating data:
|
| OUTER_REPEAT |
Refers to the Form Repeat values of all applicable form types with repeating data:
|
| IS_MISSING_FORM |
Note: For forms in the Logs visit, IS_MISSING_FORM is reported as N. This is expected behavior because Logs visits, unlike scheduled visits, do not have a visit start date or a projected visit end date. |
| LOCKED | Indicates the lock status of the given form. This field can have the following values:
|
| LAST_UPDATED_BY |
Indicates the information of the user who made the last change on the clinical data. This is only populated for the record of the latest change and it is associated with the data stored in the LAST_UPDATED_DATE data element. Note: The data contained in this element can only be used for current records from the dataset, marked as IS_CURRENT=Y, as the data updates independently of form status versioning. |
| LAST_UPDATED_DATE |
Indicates the time of the most recent clinical data change within a particular form. This includes entering data, clearing data, or restoring data. If no clinical data has been entered in a form, this data element displays a value of Note: The data contained in this element can only be used for current records from the dataset, marked as IS_CURRENT=Y, as the data updates independently of form status versioning. Moreover, the data contained within this element does not change as a result of Sign, Freeze, Verify, and Lock (SVFL) actions, nor does it change as a result of form associations or site transfers. |
Parent topic: Subject Forms dataset
Form Association folder
Note:
Only current records show the form association details. Audit records do not include any form association information.| Data element | Description |
|---|---|
| ASSOCIATED_EVENT_INSTANCE_NUM |
The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
| ASSOCIATED_EVENT_NAME | The name of the associated event. |
| ASSOCIATED_FORM_NAME | The name of the associated form. |
| ASSOCIATED_FORM_REFNAME | Indicates the reference code of the associated form. |
| ASSOCIATED_FORM_TYPE | Indicates the form type of the associated form. |
| ASSOCIATED_REPEAT_SEQUENCE_NUM | When association is with a repeating form, indicates the associated sequence number. |
| ASSOCIATED_STUDY_VERSION | Indicates the study version of the associated form. |
| ASSOCIATED_REPEAT_FORM_NUM | When association is with a repeating form, indicates the associated repeating form number. |
Parent topic: Subject Forms dataset
Audit folder
Table 3-75 Data elements in the audit folder
| Data element | Description |
|---|---|
| IS_CURRENT |
Audit trail field to indicate if the record represents current data. Displays:
Note:
|
| VERSION_START |
As this dataset contains past and current records, the version start indicates the date and time when a given record was created. This data element indicates the moment when the form got associated with the subject:
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, the version end indicates the date and time when a change was applied that made the given record to stop being current. If the record 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:
Note: For form records in skipped visits, OPERATION_TYPE is set to CLEARED. |
| 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. |
| 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. |
| FORM_EVENT_TYPE | Indicates the type of event for changes in form status records. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL.
|
| OBJECT_VERSION_NUMBER | Audit trail field that represents a sequential number for records about operations on a same element. |
| REASON | For data entry, clear form, and delete form actions, you see system generated values such as Other or the form name. For the restoration of a deleted form, you see the user-entered value. |
| 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. |
Parent topic: Subject Forms dataset
Aggregation folder
This table describes the data elements included in the Aggregation folder.
Table 3-76 Data elements in the Aggregation folder
| Data Element | Description |
|---|---|
| TOTAL_ITEMS |
Number of total questions in a form. |
| ENTERED_ITEMS |
Number of questions answered in a form. |
Parent topic: Subject Forms dataset
Reference folder
This table describes the data elements included 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 |
|---|---|
| SCHEDULED_FROM_EVENT_WID |
A number that represents the parent visit from which the associated visit was scheduled, as a unique identifier within the study. |
|
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. |
|
SUBJECT_WID |
A number that represents the subject, as a unique identifier within the study. |
|
EVENT_WID |
A number that represents the event, as a unique identifier within the study. |
| SUBJECT_EVENTINST_FORM_WID |
A number that represents a subject form associated with a specific visit instance, as a unique identifier within the study. |
| FORM_WID |
A number that represents the form, as a unique identifier within the study. |
|
USER_WID |
A number that represents the user, as a unique identifier within the study. |
|
DH_TIMESTAMP |
A timestamp that indicates when the data became available in the dataset. |
| SUBJECT_EVENT_INST_WID |
A number that represents the subject's event instance, as a unique identifier within the study. |
|
COUNT |
Represents the count of records in the dataset. |
| ASSOCIATED_EVENT_WID |
When a form association is present, indicates a number that represents the event to which the form is assigned, as a unique identifier within the study. |
| ASSOCIATED_FORM_WID | A number that represents the associated form, if present, as a unique identifier within the study. |
|
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. |
| LAST_UPDATED_BY_WID |
A number that represents the user who performed the last update, as a unique identifier within the study. |
|
SOFTWARE_VERSION_NUMBER |
A number that increases incrementally every time a data point is modified. |
Parent topic: Subject Forms dataset