Subject Data Extract
Data managers and statisticians can extract cumulative subject data for data analysis or regulatory reporting of a given study.
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 1Modes
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
- 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.
- If you generate a data extract to include form association, the output will
be in a separate file in a CSV or sas format, named either
FORMASSOCIATION.csv or FORMASSOCIATION.sasbdat, generated from XPORT/CPORT
formats. For example, if an Adverse Event includes a form association to
Concomitant Medications where each adverse event has one or more
associations to concomitant medications. The output form association file
will show all form associations between the source, in this case, the
Adverse Event, and linked forms, respectively Concomitant
Medications.
Note:
An existing study can generate a Subject Data Extract to include any form association data set only if it's included in the study design.
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:
|
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.
|
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:
|
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.