Subject Data report

The report includes audit information on several levels:

For every question, you can see who entered the data and whether any changes were made to it, including the date and time of any changes.
For every visit, you'll see one row for every time something happens in a visit, such as when a new form is started and saved.

There are no standard data points in this report, and that's because form design in Oracle Clinical One Platform is flexible: You can collect whatever data points that you want in a study. For instance, if you want the report to include information about a subject's date of birth, you must include a DOB question on a form, or the data point won't be included in the report.

The following information appears in the report header:

Name of the report
Name of your organization and the study
Mode the report was run for
User who ran the report and the date and time the report was run

The body of the report contains one entry for each time a site user enters or updates a value, along with the following information for the data point that was collected:

Study version for which the data was collected
Site that the data was collected at
Subject ID and subject number for whom the data was collected
Date the data was entered
Visit, form, and question the data was collected for
Value entered by the site user
Unit of measure on the question, or N/A if not relevant
Reason for change and a comment, if a value was updated; or N/A if not relevant
Note:
If the verified information collected on a repeating form is deleted, two records are added under the Reason for change column of the report:
- The first will reflect DELETE REPEATING FORM.
- The second will reflect N/A.
Under the Reason for change column of the report, the first record will reflect DELETE REPEATING FORM. The second record will reflect N/A under the same column.
Validation error on the question, or N/A if not relevant
User who entered the data

Note:

Hidden questions are included in the report only if the user generating the report has the permissions to view or edit hidden data.

Modes

Available in all 3 modes: Testing, Training, and Production

Permission required to run the report

Any user who's assigned the Run the Subject Data Report permission can generate this report.

Filters

Filter	Description
Study Version	Choose a study version to include only data collected for that study version, or choose All to include data collected in all study versions.
User Name	Choose a user to include only the changes made by that user, or leave the filter blank to include changes made by all users.
Location	Choose a site or depot to include only the data collected at the location, or leave the filter blank to include changes at all locations.
Subject Number	Choose a subject to include only the data collected for the subject, or leave the filter blank to include data for all subjects. Note: If a subject is removed from a study and its subject number is subsequently reused, then there will be two entries for that subject within the report.
Visit Title	Choose a visit to include only data collected during that visit or leave it blank to include data collected in all visits.
Form Title	Choose a form to see only data collected with that form or leave it blank to include data collected for all forms included in a visit or in a study version.
Question label	Select a question label to see the data collected for that question or leave it blank to view data that was collected for all questions included in the form you previously selected.
File Type	Choose the output type for the report: CSV, HTML, or PDF.
Include/ Exclude cleared Data	Choose to include or exclude cleared data from the Subject Data Report. Note: Default permissions are set to exclude the data.

Field descriptions

Note:

Fields that don't have any corresponding values are marked as N/A in the report.

Initial fields	Description
Customer Name	A customer's name used to purchase the cloud subscription
Study Name	A study's ID as entered by the study manager when they created the study
Mode	The mode in which you ran this report. For example, you may run a report in Testing mode to verify the data before going live with your study
Study version	The number of the study version for which the subject data was collected
Form Title	Name of the form you selected to include in the report
Report Generated By	User name of the user who generated this report
Created Date	UTC time and date of the current generated report
Visit Title	Name of the visit you selected to include in the report

Fields in every subject's section	Description
Study Version	Study design version for the visit
Site	A site's name
Subject ID	A subject's GUID in the system
Screening Number	The number assigned to a subject after screening or enrollment. Note: This matches the Subject Number column unless you are Replacing the Subject Number with the Randomization Number.
Subject Number	User-friendly subject identifier
Lab ID	A lab's GUID in the system
Lab Name	A lab's name
Entry	UTC time and date of when the subject was first added into the system
Visit/Event Title	Name of the visit from study design. It includes branch visits and unscheduled visits and events
Visit/Event Instance	Displays every instance of an unscheduled visit or cycled branch visit for a subject
Form Title	Name of the form from study design
Repeating Form Number	A unique sequence number that is automatically assigned to a repeating form. This column also displays the unique sequence number of a two-section form instance, as well as the sequence number of a lab form.
Question Label	Name of the question from study design
Type of Change	Indicates whether a question was created, modified, signed (at the form, visit, or subject level), unsigned, verified, unverified, locked. unlocked, or frozen by a lead site user or Clinical Research Associate (CRA)
Value	Data entered, including calculated values, drop-down answer options, as well as answers for a question with check boxes or radio buttons
Unit of Measure	Value from study design when a question is designed as a number type of question
Reason for Change	Indicates a reason for changes in a subject's data. Populated by drop-down list
Reason for Change Comment	Required comment in a reason for change if ‘Other’ is selected Populated as Rule Execution for calculated values
Validation Error	Populated if the form field has validation failure due to rule execution. For example, age is outside the allowed range
User Name	User name of the user responsible for this transaction