Titration Summary (Unblinded) report

In this report, you view titration details for all subjects and visits at a site or at multiple sites. This report is useful for unblinded users who want to verify dispensation and titration data at a site, as well as treatment arm information.

Modes

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

Permission required to run the report

Any user who's assigned the Run the Unblinded Titration Summary Report permission can generate this report.

Filters

Filter	Description
Site	Select a specific site to only include visits and titration data for that specific location or leave it blank to include visits and titration data for all sites in a study.
Treatment Arm	Choose a treatment arm to only include the visits during which a specific treatment arm was assigned to subjects or leave it blank to include data for all treatment arms.
Subject	Choose one or more subjects to only include visits for these specific subjects or leave it blank to receive visit data for all subjects included in the study.
File Type	Choose the output for the report: CSV, HTML, or PDF.

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.
Report Generated By	User name of the user who generated this report.
Created Date	UTC time and date of when this report was run.
Site	The site you selected for this report.
Subject	The subjects you selected for this report.
Treatment Arm	The treatment arms you selected for this report.

Fields about titration data in a study	Description
Subject	This data point is displayed in a report's header. The subject's number.
Treatment Arm	This data point is displayed in a report's header. The treatment arm the subject is on.
Visit	A visit's name as completed by a site user.
Titration	Kit type titration associated with a visit.
Unscheduled Visit Number	An unscheduled visit's number during which dose changes were performed.
Title of Dose Level	Dose level title assigned to each blinded kit type titration.
Kit Number	Kit numbers used in titrations, as well as their descriptions. Includes calculated dose level description and locally sourced number if applicable.
Duration from Last Dose Change	Number of days from a subject's last dose change.
Dispensation Date	Date stamp of when the last dispensation occurred.
Projected Dispensation Date	Date of the upcoming dispensation visit.
Last Modified By	User name of the user who last performed this transaction.

Titration Settings	Description
Maximum Dose Changes	Indicates the maximum number of dose changes for a subject. Can display the limit for total titrations or for up and down titrations separately, depending on the study design configuration.
Minimum Time Between Dose Changes	Indicates the minimum time allowed between dose changes. Can display the limit for total titrations or for up and down titrations separately, depending on the study design configuration.
Dispense when on Highest Dose and Site Wants Higher Dose	Indicates whether a site user is allowed to dispense when a subject requests a higher dose but they're already on the highest dose. Yes means to keep a subject on their current dose level when the subject is already on the highest dose and the site asks to titrate up. No means to prevent dispensation when the subject is already on the highest dose and the site asks to titrate up. The subject remains in the study, and if subject decides to maintain their current dose, dispensation can still occur.
Message for Site Users	Indicates the custom message to display at dispensation when an up titration request occurs and the subject is already on the highest dose.
Dispense when on Lowest Dose and Site Wants Lower Dose	Indicates whether a site user is allowed to dispense when a subject requests a lower dose but they're already on the lowest dose. Yes means to keep a subject on their current dose level when the subject is already on the lowest dose and the site asks to titrate down. No means to prevent dispensation when the subject is already on the lowest dose and the site asks to titrate down.
Message for Site Users	Indicates the custom message to display at dispensation when a down titration request occurs and the subject is already on the lowest dose.

Titration Excepetions	Description
Titration Exception Type	Indicates whether the exception is applied to an up titration or a down titration.
Starting Dose Level Description	Indicates the description of the starting dose for the titration to which an exception is applied. Includes the calculated dose level description if applicable.
Minimum Time Between Dose Changes	Indicates the minimum time allowed between dose changes as an exception to the standard time in the titration settings (see table above).
Ending Dose Level Descritpion	Indicates the description of the ending dose for the titration to which an exception is applied. Includes the calculated dose level description, if applicable.