Subject Randomization Data Extract

Extract cumulative data including randomization details, such as randomization number, associated treatment and startification data. Blinded and unblinded extracts are available depending on your permissions.

Modes

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

Roles that can extract data

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

The Subject Randomization Data Extract can contain blinded or unblinded data, depending on your permissions within the study. Having at least one of the following permissions makes unblinded data available in the generated extract:

WARNING:

If you generate this extract as an unblinded user, you must be careful when sharing to protect other users blinding.

Receive the Unblinded Dose Hold Notification
Upload and Generate Inventory Lists
View Dispensation Exceptions
Create and Manage Dispensation Exceptions
Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies
Manage Study Inventory for Unblinded Users
Manage Randomization Lists
Create and Manage Lots
Create Shipments to Depots
Upload and Generate Randomization Lists
Receive the Unblinded Kit Misallocation Notification
View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies
Run the Unblinded Randomization Report

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 Randomization Data Extract:

This report includes only records of randomized subjects.
If the extract is generated before the first subject is randomized, an empty dataset is created that includes all fields except for the stratification factors. Stratification factors are added to the dataset when the first subject is randomized. To view this data you need to generate a new extract.
Only values that were used for a given subject as stratification factors at the time of randomization are populated for the subject. This means that, even if the site updates this data for a subject after randomization, the values that were actually used to determine randomization are retrieved.
Whenever a subject is re-randomized, a second record is created for the same subject in the report.

Note:
For manual updates to a subject's randomization details (randomization number and treatment arm), no new record is created and the original data is displayed.
If a subject is re-randomized and no new randomization number is assigned, the second record for the subject displays empty fields for Randomization Number, Treatment Arm, and Block ID.
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, XPORT or sas7bdat 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 and question label are used instead.

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

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: <Study Name>_File Name>_<Time stamp> <Study Name>_<File Name> <File Name>_<Time stamp> <File Name>
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)	This field is usually blank. 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 in the format: <Last Name>, <First Name>.
USUBJID	Unique Subject ID (GUID)	Unique subject ID across all studies for all applications or submissions involving the product.
SUBJID	Subject Identifier (Subject Number)	Indicates the unique subject number within the study.
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.
VISITNUM	Visit Identifier	Indicates a visit's ID for the visit where randomization event occured.
VISIT	Visit Title	Indicates the title for the visit where randomization event occurred, as specified by the study designer.
UNSCHED	Unscheduled/Cycle Visit Instance Number	Indicates the unscheduled visit instance number, and cycle number for cycle visits, as designed by the study designer.
SVSTDTC	Visit Start Date (Start Date/Time of Visit)	Indicates the randomization visit's start date, represented in ISO 8601 character format.
DOMAIN	Form Reference Code (Source Form)	Indicates the source form's reference code. This value, for the source dataset of this data extract, is always RAND_SYS.
ENTEREDBY	Initial user to enter data into the Visit/Stratification	Indicates the user name of the user who first enetered any stratification data or who started the randomization visit, whichever happens first. In case of re-randomization, only the newest randomization event is considered.
ENTEREDDT	Initial date data entered into the Visit/Stratification	The UTC time and date of when the user first enetered any stratification data or started the randomization visit, whichever happens first. This date is represented in ISO 8601 character format (YYYY-MM-DDTHH:MM:SSZ). In case of re-randomization, only the newest randomization event is considered.
LASTCHANGEDBY	Last user to modify data prior to Randomization	Indicates the user name of the latest user to have modified any stratification factor value or randomization visit data prior to randomization. Queries are not taken into account as updates. In case of re-randomization, only the newest randomization event is considered.
LASTCHANGEDDATE	Last date data modified prior to Randomization	The UTC time and date of when a stratification factor value or randomization visit data was last modified, prior to randomization. Represented in ISO 8601 character format (YYYY-MM-DDTHH:MM:SSZ).
DSSTDAT	Randomization Date	The UTC time and date of when the subject was randomized, represented in ISO 8601 character format (YYYY-MM-DDTHH:MM:SSZ). In case of re-randomization, only the newest randomization event is considered.
SUBJDOB	Subject Date of Birth	Indicates the subject's date of birth, as entered by the user including unknown elements. This field is populated with the value from the question identified with the Date of Birth Subject Tag, as per design. If the tag is not used in the study or there are multiple fields collecting a subject's date of birth, this field is blank. The raw (_R), formatted (_F) and decoded (_D) values are also available as part of this extract. For more details see Form item output mapping in data extracts.
SUBJDOB_R	Subject Date of Birth	Indicates the raw value for the subject's date of birth: as entered, in alphanumeric format (no date format). For more details see Form item output mapping in data extracts.
SUBJDOB_F	Subject Date of Birth	Indicates the formatted value for the subject's date of birth: as a complete date or date/time using the format specified in the form's design in Oracle Clinical One Platform. For more details see Form item output mapping in data extracts.
SUBJDOB_D	Subject Date of Birth	Indicates the decoded value for the subject's date of birth: using an ISO 8601 date format (YYYY-MM-DDTHH:MM:SSZ), managing partial and full datetime values (unknown elements are omitted). For more details see Form item output mapping in data extracts.
RANDID	Randomization Number	Indicates the randomization number assigned to the subject. Note: In the case of re-randomization, if a treatment arm is already mapped, a new randomization number isn't assigned to the subject and the randomization information is not updated.
BLOCK	Block Number	Indicates the block number of randomization to which the subject is assigned. This field remains empty for blinded users.
COHORT	Cohort Label	Indicates the label for the cohort where the subject belongs. This value is `null` for a minimization randomization.
STRATUM	STRATUM GROUP	Indicates the stratum group where the subject belongs. This value is `null` for a minimization randomization.
TREATARM	Treatment Arm	Indicates the treatment arm that is assigned to the subject. This field remains empty for blinded users.
Stratification factors Note: There is one entry for each stratum factor defined in the randomization design. These columns' titles are dynamically fetched based on how the SAS Variable is defined for each stratification factor at the form level.	Label as defined for the form item.	Lists the stratification factors data. A stratification factor is any form question identified in the randomization design as a stratum factor. Site, region and country data are not included. The values for the stratum factors, defined in any version for the given mode, are listed in separate columns for each, considering the following: Four columns are added for each stratum factor: the item itself, the raw (_R), formatted (_F) and decoded (_D) values. Differences between them depend on the answer's data type. For more details, see Form item output mapping in data extracts. Only values that were used for a given subject as stratification factors at the time of randomization are populated for the subject. If stratification factors are not specified, no stratification factors will be listed. In case of re-randomization, these fields are blank for the newly created record. For the stratification factors collected in repeating forms or in forms present in more than one instance prior to randomization, the stratum factors are not included in the extract. In Testing mode, if a stratification factor is removed from the design after a subject has been randomized, that question is not included in the extract. Note: This is not applicable to Production mode as questions cannot be deleted from an approved version.

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.