Lab Normal Data report

Find details about registered data for lab normal ranges entered at a single site and across all sites, labs and periods.

Details in the report include the following:

• The total number and details for data entered for all sites, lab names and date ranges.
• An audit history option in the data entry field for the date range.
• All changes that have been made to the lab data (only if historical information is included).
• View of only the associated labs when you select specific sites.

Modes

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

Permissions required to run the report

Users with the right to enter and view lab normal ranges, such as Data Manager, CRA, and View Only Unblinded Support template roles, who are assigned the permissions LabNormalReportPost and Lab Normal Range Report can generate this report.

Initial field details

If no data was entered for a lab, the filter list still shows in the drop-down and the report shows test results listed with the indicator N/A for all values.

Filter	Description
Customer Name	The customer name.
Study Name	The given name of the study.
Mode	Testing, Production, or Training
Report Generated By	Email address of the user who generated the report.
Created Date	Date and time (in UTC) when the report was generated.
Include Audit Trail (optional)	Select whether to include historical audit information or not.
Date Range (optional)	Date and time (in UTC) to determine the date range for the changes to be included in the report. The date range applies only if the Include Audit Trail option is selected.

Field descriptions

Field	Description
Lab ID	The number assigned to the lab.
Lab Test Name	The name of the lab test to which the normal range is associated to. Values as entered by the user.
Lab Unit	The unit of measure used for collecting and measuring data for the lab test. For example, U/L or ng/mL for a creatine kinase (CK) test. Values as entered by the user in the code list.
Low Range	The lower limit of the lab normal range.
High Range	The upper limit of the lab normal range.
Normal Text Result	The value that can be used as a reference for a lab test. For example, Negative for an HPV test.
Fasting	The value entered by the user in the code list. Options Yes, No, and All are predefined in the system, but a study designer can use other options, such as Fasting and Not Fasting, when defining the code list for the Fasting question on a lab form.
Gender	The gender that the lab test normals applies to. If All is displayed, means it applies to all genders defined. Note: The All option is typically used when a study doesn't collect geneder data.
Age From	A number for the minimum age included in the age range for a lab test.
Age From Units	The unit of measure for a subject's age (months, years, etc).
Age To	A number for the maximum age included in the age range for a lab test.
Age To Units	The unit of measure for a subject's age (months, years, etc).
Race	The values entered by the user in the code list. If All is displayed, means it applies to all races defined in the lab normals. Note: The All option is typically used when a study doesn't collect race data.
Effective Date	The date from which the lab normal range became effective at the laboratory.
Entered by	Indicates the user name of the user who initially entered data into the form.
Entered date	Date and time (in UTC) when the item was first added.
Last Updated By	Identifies the user who last modified the item.
Last Updated Date	Date and time (in UTC) that a user last modified the item.
Action	The type of action that was performed on the data. The options are: Created Modified Deleted
Associated Site(s)	One or more sites that the lab assigned to, including retired labs. The list only shows options based on your access, on the selected period, and currently associated labs with the selected site.