Subject Data Extract

Data managers and statisticians can extract cumulative subject data for data analysis or regulatory reporting of a given study.

The Subject Data Extract is particularly useful for improving the overall data collection process and making sure the study's data is of the best quality, as well as proving the study's efficacy through data analysis.

Note:

In Oracle Clinical One Platform, SAS Transport File Formats are currently running on Version 8, so make sure you use a SAS client that's on version 9.3 or later. For more details, see the SAS documentation platform.^Foot 1

Modes

Available for all 3 modes: Testing, Training, and Production.

Roles that can extract data

Any user that's assigned the Run the Subject Data Extract permission can generate this report. Users with this permission can only see the data that they're allowed to either view or edit, based on their access to classified data.

The Subject Data Extract can contain blinded or unblinded data, depending on your permissions within the study. Hidden questions are included in the report only if the user generating the report has the permissions to view or edit hidden data.

Output details

Here is a list of details on how data may be displayed in the Subject Data Extract:

For any code lists you use in your study for answer options in forms, the codes will be displayed in the data extract, to follow the SDTM terminology.
If a numeric value that contains leading zeros (0) is collected through a form, that numeric value is displayed without its leading zeros in the data that you extract in either a CPORT or XPORT format.
For example, if a site user collects a value of "0001.12345", the data extracted in a SAS format displays that value as "1.12345".
Make sure you define SAS properties. If the SAS properties are not defined in a study's design, the form reference code is used instead and it is also displayed in the Subject Data Extract.
For a two-section form, questions in the Questions Before the Table section and the Questions in the Table section are merged to offer you a consolidated view of what data to analyze.
For a lab form, the Sample Collection Date and the Fasting questions are merged, as well, for the same reasons.
Records of cleared forms are not included. This also applies to deleted repeating forms.
If you clear all elements in a form, the record is not included. Similarly, if you clear the data from the parent question of a dynamic form, which results in dynamic form being hidden, no record of that form will be included in the extract.
If a site user does not answer a question or they apply a data flag to it, the corresponding field in the extract will be populated with a code specific to each data flag. The following codes can be displayed:
- Not Applicable (NA): C48660
- Not Done (ND): C49484
- Unknown (UNK): C17998
- Not Answered: -99999
- Note:
  If all questions of a form have had the Not Answered flag applied, the form will not be included in the report.
In the extract's columns, the code for every data flag is displayed in the QUESTIONLABEL_D column. Depending on a question's type, the code can also be displayed in the QUESTION LABEL column. The abbreviation (such as NA) is displayed in the QUESTIONLABEL_R column. For more details see Form item output mapping in data extracts.

Settings

Filter	Description
File Name	Select the appropriate name convention for your data extract. These naming conventions are only available for data extracted in a CSV format: <Form Name> <Study Name>_Form Name>_<Time stamp> <Study Name>_<Form Name> <Form Name>_<Time stamp>
Site	Choose one or more sites that you're assigned to. This drop-down includes sites in all states: New, Active, Retired.
File Type	Choose the output type for the report: Transport (XPORT), CPORT, CSV, or sas7bdat. A CSV or SAS file is generated for each form designed in the study. Each question or item in each form will contain four corresponding columns as described in the Field descriptions section below. If generated in a SAS format, such as Transport (XPORT) or CPORT, the data extract will consist of a ZIP file containing a SAS proprietary dataset for each form with the SAS Label and Variable for each data element within a form. A sas7bdat extract is generated in a ZIP file format. If you only need to view data in a Subject Data Extract, then we recommend you extract data in a CSV format for a more flexible and faster user experience.

Field descriptions

Key Column	SAS Label	Description
TENANTID	Tenant Identifier	Indicates the organization identifier.
STUDYID	Study Identifier	A study ID as specified by the study manager when they created the study.
COUNTRY	Country of Investigator Site	A site's country as specified by the site manager when they created the sites in Oracle Clinical One Platform.
SITEID	Site Identifier	Indicates the site's ID.
INVID	Investigator Identifier (DEA Number)	A principal investigator's ID as specified by the site manager when they created the sites in Oracle Clinical One Platform.
INVNAM	Investigator First and Last Name	A principal investigator's name as specified by the site manager when they created the sites in Oracle Clinical One Platform.
USUBJID	Unique Subject ID (GUID)	Unique subject ID across all studies for all applications or submissions involving the product.
SCRNID	Screening Number	The number assigned to a subject after screening or enrollment. Note: This matches the SUBJID column unless you are Replacing the Subject Number with the Randomization Number.
SUBJID	Subject Identifier (Subject Number)	Indicates the unique subject number within the study.
VISITNUM	Visit Identifier	Indicates a visit's ID as specified by the study designer.
VISIT	Visit Title	Indicates a visit or event title as specified by the study designer.
UNSCHED	Unscheduled Visit Instance Number	Indicates the unscheduled visit instance number as designed by the study designer.
SVSTDTC	Visit Start Date (Start Date/Time of Visit)	Indicates a visit's start date, represented in ISO 8601 character format.
LABID	Lab ID	The Lab ID.
NAM	Lab Name	The Lab name.
DOMAIN	Form Reference Code	Indicates the form's reference code as a two-character abbreviation.
REPEATNUMBER	Row number in a repeating form.	For different types of forms, this column displays data in the following ways: For one-section (flat) forms, these fields are not populated. For repeating forms, this column is populated with the number of repeating form instances used in a study. For lab forms and two-section forms, this column is populated with the instance number of each lab form.
ENTERED BY	The user who initially entered data into the form.	Indicates the user name of the user who initially entered data into the form or answered a question.
ENTERED DATE	The date when the user entered data into the form. Date is UTC Timezone.	The UTC time and date of when the user entered data into the form or answered a question, represented in ISO 8601 character format.
LAST CHANGED BY	The latest user or system user who modified any form item.	Indicates the user name of the latest user to have modified any questions on the form. Queries are not taken into account as form updates.
LAST CHANGED DATE	The latest date of any form item that is modified. Date is UTC Timezone.	The UTC time and date of when a question was last modified, represented in ISO 8601 character format.
QUESTION LABEL	The answer to the question label.	Indicates the answer to a question as entered by a site user.
QUESTION LABEL_R	The question label's raw value.	Indicates the raw value: alphanumeric value as entered in Oracle Clinical One Platform with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts.
QUESTIONLABEL_F	The question label's data type.	Indicates the formatted value: value as entered in Oracle Clinical One Platform converted to the question data type as per form design. For more details see Form item output mapping in data extracts. Note: Incomplete date/time data will not be exported under this column, but will still be available under QUESTION LABEL_R. This means that all date/time data collected prior to the Oracle Clinical One Platform 22.3 upgrade will not be available under this column.
QUESTIONLABEL_D	The question label's data type for the answer.	Indicates the decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts.
DeletedQn	Deleted Questions	If a form item was deleted in a previous version of the study, but data had been collected for it, this data will be displayed under this column. Note: The SAS Label of the deleted form item will be displayed as D<GUID>, using the deleted form's GUID.
SOURCEFORMID	Source Form ID	Indicates the ID of the source form, that is the form which contains the question that launches a form association.
SOURCEITEMID	Source Item ID	Indicates the source item ID. The source item is the question/item that launches a form association.
RVISITNUM	Related Visit ID	Indicates the ID of the visit that contains the form with which the source form is related/linked.
RVISIT	Related Visit Title	Indicates the name of the visit that contains the form with which the source form is related/linked.
RVISITINST	Related Unscheduled/Cycle Instance	Indicates the instance number of the unscheduled visit or cycle visit that contains the form with which the source form is related/linked.
RSVSTDTC	Related Visit Start Date	Indicates the start date of the visit that contains the form with which the source form is related/linked.
RELID	Related Record ID	Indicates the ID of the repeating form instance with which the source form is related/linked.
RDOMAIN	Related Form Name	Indicates the name of the form with which the source form is related/linked.
RFORMID	Related Form ID	Indicates the name of the form with which the source form is related/linked.
RREPEATNUMBER	Related Repeat Number	Indicates the number of the repeating form instance with which the source form is linked.
RSREPEATID	Related Repeating Section Unique Identifier	Indicated the instance number of the flat section with which the source form is linked.
RSREPEATNUMBER	Related row number in a repeating section	Indicated the instance number of the section with which the source form is linked.
REPEATNUMBER	Row number in a repeating form	In case of a two-section form or a lab form, this number indicates the instance ID of a two-section form. The same ID is displayed for the Questions Before the Table section and the Questions in the Table section. As the SAS Label indicates, this also represents the row number for a repeating row.
SREPEATID	Repeating Section Unique Identifier	This is a unique number assigned to the Questions in the Table section of a two-section form, including a lab form.
SREPEATNUMBER	Row number in a repeating section	This is a row's unique number (whether located in a lab form or a two-section form). This number is unique for every section (in a two-section form), form, and event for a subject.

Related Topics

Parent topic: Data extract descriptions

Footnote Legend

Footnote 1: SAS is a registered trademark or trademark of SAS Institute, Inc. in the USA and other countries. Other brand and product names are registered trademarks of their respective companies.