Study Design dataset
You can use the Study Design dataset to analyze and visualize data collection design data in Oracle Clinical One Analytics that will allow you to identify differences between study versions and across modes.
Modes
This dataset displays data collection design details of a study version available in any mode. However, this datset does not include study design details from any study version moved directly from draft mode to archived.
Note:
For a study version in draft mode to be available, you need to manually publish data by clicking Send to Analytics in the draft mode dropdown. This option is only available to the following template study roles:- Study Designer
- View Study Design
- Data Manager
- User Administrator
What type of data can I include in a custom report or visualization on Data Collection design?
With this dataset you can:
- Create a report to analyze data collection design and schedule
- Identify visits schedule and forms design
- Identify differences between study versions and modes
- Verify changes made in a study version before moving it to production
- Create a time and events table
For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.
Browse description of data elements included in this dataset:
Parent topic: Dataset descriptions
Study folder
This table describes the data elements included in the Study folder
Table 2-39 Data elements in the Study folder
Data element | Description |
---|---|
STUDY_ID_NAME | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
STUDY_TITLE | A protocol's title as specified by the study manager. |
STUDY_REFNAME | The STUDY_ID_NAME data element that is converted to uppercase and spaces are removed. This value never changes after created even if STUDY_ID_NAME changes. |
STUDY_PHASE | A study's phase as indicated by the study manager when they created the study. |
THERAPEUTIC_AREA | Indicates the therapeutic area as specified by the study manager when they created the study. |
BLINDING_TYPE | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. |
STUDY_VERSION | Indicates the study version number of the referencing data in a custom report. |
STUDY_DESIGN_STATUS |
Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. |
DH_TIMESTAMP | A timestamp that indicates when the data became available in the dataset. |
MODIFIED_BY | The user who last modify the study. |
VERSION_END | Indicates the date and time of when data was changed, if the data is not current. |
VERSION_START | Indicates the date and time of when the data was changed. |
Parent topic: Study Design dataset
Branch folder
This table describes the data elements included in the Branch folder
Data element | Description |
---|---|
BRANCH_TITLE | Indicates the branch title or name. |
IS_CYCLE_BRANCH | States whether the branch is cycled or not. |
CYCLE_COUNT | Specifies the number of cycles in case the branch is cycled. |
ASSIGN_SUBJECTS_USING_TREATMENT_ARM | Indicates if subjects are assigned to the branch by Treatment arm. |
ASSIGN_SUBJECTS_USING_FORM_QUESTION | Indicates if subjects get assigned to branch by a form question. |
BRANCH_ARM | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
BRANCH_FORM | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
BRANCH_QUESTION | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
BRANCH_ANSWER | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
BRANCH_VISIT | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
Parent topic: Study Design dataset
Event folder
This table describes the data elements included in the event folder.
Table 2-40 Data elements in the event folder
Data element | Description |
---|---|
VISIT_IS_REQUIRED | Indicates whether or not a visit is required. |
IS_SCHEDULED_VISIT | Indicates whether the visit is scheduled or not. |
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, as it is the first visit in the schedule. |
VISIT_TYPE | Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion. |
EVENT_TYPE | Displays the type of event:
|
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). |
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 Oracle Clinical One Platform 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 Oracle Clinical One Platform. |
VISIT_HOUR_SEQ_ORDER | The order in which subject visits occur, as configured in the study design. |
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. |
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. |
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 the visit’s own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
Parent topic: Study Design dataset
Form folder
This table describes the data elements included in the Form folder.
Table 2-41 Data elements in Form folder
Data element | Description |
---|---|
FORM_NAME | The name of the form, as specified by the study designer. |
FORM_TYPE | Indicates the type of form:
|
FORM_IS_ROLLOVER | Indicates whether the form is rollover or not. |
FORM_IS_REPEATING | Indicates whether the form is repeating or not. |
FORM_REFNAME | A form's reference name. |
ALLOW_ADDITIONAL_ROWS | Indicates if this is a repeating form that allows additional rows. |
SOURCE_DATAVIEW_NAME | If it is a copied form, indicates the original form it was copied from. |
SOURCE_STUDY_NAME | If it is a copied form, indicates the name of the study it was copied from. |
SOURCE_STUDY_VERSION | If it is a copied form, indicates the study version of the study it was copied from. |
SOURCE_VERSION_START | If it is a copied form, indicates the date and time of when the copied data was entered. |
RULE_COPY_STATUS | If it is a copied form, indicates the status of the source form rules copy. |
Parent topic: Study Design dataset
Item folder
This table describes the data elements included in the Item folder.
Table 2-42 Data elements in Item folder
Data element | Description |
---|---|
ITEM_NAME | Indicates the title of the question, as entered by a study designer |
GROUP_TYPE | Indicates if this is a group question. |
MEASURE_UNIT | Indicates the measure of unit specified by a study designer for a Number type of question |
QUESTION_HINT | Indicates information that a study designer provided as a hint to help answer a question. |
QUESTION_TYPE | Indicates the type of question as defined by a study designer. |
FORMITEM_IS_REQUIRED | Indicates whether the question is required or not. Required questions must be answered in order to save the form that contains it. |
READONLY | Indicates that the question is marked as read-only by a study designer |
SAS_VARIABLE | Indicates the SAS Variable of a form defined by a study designer |
SAS_LABEL | Indicates the SAS Label of a form defined by a study designer |
REFERENCE_CODE | Indicates a question's reference code |
ITEM_GROUP | If this is a group question, indicates the group question title. |
HIDDEN | Indicates whether a question is hidden or not, as marked by a study designer |
ITEM_VALUES | The raw value of the form question value (can be an array in questions with decodes) |
CODELIST_VALUES | Lists the codelist values added as answers to the current question. |
VALIDATION_RULES | Specifies the question's validation rule if any.
Validation rules types available depend on the type of question:
|
RULE_ERROR | Reason for failure if validation status is failed or the rule validation failed |
ACTION_RULES | Details the action rule of a question which can be of
the types:
|
SDV | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). |
CODE_QUESTION | If the question has a Coding Question
property, lists the following information:
|
FORMAT | Specifies the answer format. For example an specific date format, or the number of decimals after the point |
Parent topic: Study Design dataset
Reference folder
This table describes the data elements in the Reference folder.
Data element | Description |
---|---|
SOURCE_DATAVIEW_WID | If it is a copied form, indicates the numeric identifier of the form it was copied from. |
SOURCE_STUDY_WID | If it is a copied form, indicates the numeric identifier of the study it was copied from. |
STUDY_WID |
A number that represents the unique identifier of the study. |
BRANCH_WID | Indicates the unique numeric identifier of the branch. |
EVENT_WID |
A number that represents the unique identifier of an event. |
FORM_WID | A number that represents the unique identifier of a form. |
ITEM_WID | A number that represents the unique identifier of an item. |
MODIFIED_BY_WID |
The unique numeric identifier of the user who modified the study. |
CURRENT_STUDY_ROLE_WID |
Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
Parent topic: Study Design dataset
Audit folder
This table describes the data elements included in the Audit folder.
Data Element | Description |
---|---|
CURRENT_STUDY_ROLE_NAME | Specifies of the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user. |
Parent topic: Study Design dataset