Viewing Compliance in Study Home

Study team members have access to view Study Home, where study and compliance data is available and totaled as overall amounts and by site.

Accessing Study Home

To open Study Home, access the study and select Open Study Home ().

Viewing the Overview

The data in Study Home is updated hourly, and you can see the amount of time that has passed in the top right corner of the Overview and site-specific pages. To see the exact time when it was last updated, position your pointer over the text, and the date and time are displayed.

Totals

In the totals section, you can see the totals for the following information over the duration of the study:

• Sites: The total number of sites on this study who have activated at least one version.
• Participants: The total number of participants on this study who have been activated for ePRO.
• Completed Surveys: The total number of ePRO and eClinRO surveys that have been completed on the study.
• Missed Surveys: The total number of ePRO and eClinRO surveys that have been missed on the study.

Compliance

In the pie charts, the percentage of ePROs and eClinROs that were completed on time is displayed. Completed surveys are scheduled surveys that were successfully completed on time. Missed surveys are past their due date and have not yet been submitted. As Needed, cancelled, and currently available surveys are not included in these metrics.

You can select the ePRO and eClinRO tabs to view additional compliance information by site with specific percentages and totals. To reorder the table, select the Site, Percentage, or Total column header.

Viewing Site-Specific Information

In the Sites tab, you can see general site information, including the site ID, site name, country, version status, active version, number of participants, ePRO compliance percentage, and eClinRO compliance percentage.

To view site-specific information, you can select the site you want to view in the compliance section on the Overview tab, or you can select the Sites tab. The information below is displayed:

Version Information

• Active Version: The current, active ePRO version at this site.
• Version Status: The status of the version at this site.
• Languages: The number of languages that are available to this site.

Totals

• Participants: The total number of participants at this site.
• Completed Surveys: The total number of ePRO and eClinRO surveys that were completed at this site.
• Last Survey: The submission date of the last survey that was submitted at this site.

Compliance

In the pie charts, the percentage of ePROs and eClinROs that were completed on time is displayed. Completed surveys are scheduled surveys that were successfully completed on time. Missed surveys are past their due date and have not yet been submitted. As Needed, cancelled, and currently available surveys are not included in these metrics.

You can select the ePRO and eClinRO tabs to view additional compliance information by site with specific percentages and totals. To reorder the table, select the Participant, Percentage, or Total column header.

Running Reports

In the Reports tab, you can run the following reports:

• Survey Data: This report contains the current data for ePRO and eClinRO surveys. It also includes any scoring associated with a survey.
• Compliance: This report contains a record for every survey with its related compliance status.
• Audit Trail: This report contains the audit activities, which includes all changes that are made in Studio.
• Data Changes: This report contains all data changes that were made after initial collection.

To view a report, select it and then select Run. When you run the Data Changes report, you can also select an option from the dropdown to run it for a specific site.

The report will run the report in the background, so you don’t have to stay on the page. When it’s complete, it will be downloaded to your device.

Survey Data Specifications

Exporting survey data from MyVeeva Studio generates a .CSV file with the following data specifications.

Actual Column Heading	Full Name of Column Heading	Description of Data
ROWID	Row ID	The unique identifier of the row in the data export
STUDYID	Study ID	The study name as it appears in Clinical Operations Vault
USUBJID	Participant ID	The participant's ID as it appears in SiteVault
VISITNAM	Event Name	The name of the event from the collection that started the schedule for this survey
VISITSEQ	Event Sequence	The sequence number of the event from the collection that started the schedule for this survey
QSCATID	Completed Survey Unique ID	The unique identifier of the completed survey
QSCAT	Survey Name	The official name of the survey
QSCATCD	Study Survey ID	The unique identifier of the survey in the study collection
QSCATDIS	Survey Display Name	The display name of the survey
QSSEQ	Question Number	The question number of this question
QSTEST	Question	The question text
QSTESTCD	Question Unique Identifier	The unique identifier of this question
QSTYPE	Question Type	For survey questions, the type of question For calculated scores, score"
QSMETHOD	Question Method	or survey questions, the method by which the question was answered. For calculated scores, Score
QSSTAT	Question Status	The status of a question Populates as NOT DONE if the participant selected an optional answer Does not populate if the participant provided a standard response
QSREASND	Question Not Done Reason	If the respondent selected an optional answer, the selected value Does not populate if the respondent selected or provided a standard response
QSORRES	Answer	For question blocks, the value selected or provided by the respondent For calculated scores, the score value and any text configured to appear with the score
QSORRESU	Answer Label	Only populates for number entry questions The label of the number entry question's answer field
QSSTRESC	Answer Unique ID	The unique identifier for the value selected or provided by the respondent Answers that do not have an identifier (eg. number scale) are included as-is
QSSTRESU	Answer Name	Only populates for number entry questions The identifier of the number entry question's answer field
QSDRVFL	Derived Flag	Populates as Y if the data was derived by a scoring calculation Does not populate if the data represents a survey question
QSTESTDT	Question Completion Time (UTC)	The UTC datetime when the question was completed by the respondent
QSLANG	Language	The language the survey was displayed in at the time the respondent submitted the survey
QSDTCST	Start Time (UTC)	The UTC datetime when the survey was started by the respondent
QSDTC	Completion Time (UTC)	The UTC datetime when the survey was submitted by the respondent
QSTZ	Time Zone	The time zone of the respondent at the time they submitted the survey
QSEVAL	Completed By	Who completed the survey The value of PARTICIPANT, CAREGIVER or SITE STAFF is displayed in this field.

Adherence Data Specifications

Exporting adherence data from MyVeeva Studio generates a .CSV file with the following data specifications:

Column Heading	Description of Data
Study Number	The study name as it appears in Clinical Operations Vault
Site ID	The applicable site's ID as it appears in SiteVault
Participant ID	The participant's ID as it appears in SiteVault
Event Name	The name of the survey's start event
Event Sequence	The sequence number of the survey's start event
Item Type	The type of the survey This field always populates as either ePRO Survey or eClinRO Survey.
Item Unique ID	The unique identifier of the completed survey
Item Name	The survey's official name
Item Display Name	The survey's display name
Adherence Status	The adherence status of the survey Options include AVAILABLE, COMPLIANT, LATE, and MISSED
First Available Datetime (UTC)	The UTC datetime when the survey first became available to the respondent
Due Datetime (UTC)	The UTC datetime when the survey was due for the respondent
Start Datetime (UTC)	The UTC datetime when the respondent started the survey Only populates if the survey was started
Completion Datetime (UTC)	The UTC datetime when the respondent submitted the survey Only populates if the survey was submitted
Completion Time Zone	The time zone of the respondent at the time they submitted the survey Only populates if the survey was submitted
Completed By	Who completed the survey The value of PARTICIPANT, CAREGIVER, or SITE STAFF is displayed in this field. Only populates if the survey was submitted
Database Entry Datetime (UTC)	The UTC datetime when the data for the survey entered the database Only populates if the survey was submitted
Platform	If an ePRO survey, The MyVeeva for Patients application platform the participant or caregiver used to submit Options include Android, iOS, and Web Only populates if the survey was submitted
Language	The language the survey was displayed in at the time the respondent submitted the survey or the survey was due

Audit Trail Data Specifications

Exporting audit trail data from MyVeeva Studio generates a .CSV file with the following data specifications:

Column Heading	Description of Data
Vault Id	The unique identifier of the Clinical Operations Vault
Study Id	The unique identifier of the study in Clinical Operations Vault
Study Name	The study name as it appears in Clinical Operations Vault
User Id	The unique identifier of the Clinical Operations Vault user who performed the action
Vault Username	The username of the Clinical Operations Vault user who performed the action
Action Performed At (UTC)	The UTC datetime when the action was performed
Audit Action	The action being audited Examples include CREATE_COLLECTION, ADD_LANGUAGE, UPVERSION_STUDY_SURVEY, and CAREGIVER_ASSIGNED
Event Description	Full description of the audited event Examples include Collection created, Language added, Study Survey up-versioned, and Caregiver assigned to a participant
Item Name	The name of the item being audited Examples include COLLECTION, EVENT, and STUDY_SURVEY
Item Id	The unique identifier of the audited item
Item Data	The referenced data within the item being audited Examples include Collection v1 : Study Withdrawal and Collection v1 : Japanese (ja)
Field	The referenced field within the item being audited Does not populate if no field exists Examples include reviewed, licensed, and display_name
Old Value	The old value of the referenced field within the item being audited Does not populate if no old value exists Examples include No, Easy, and Pain Survey
New Value	The new value of the referenced field within the item being audited Does not populate if no new value exists Examples include Yes, Moderate, and New Pain Survey
Reason for Change	Contains the reason for a data change This field only populates if a data change is requested by a site and processed by Veeva.