Exporting Survey, Adherence, and Audit Trail Data

Export ePRO-related data in Study Connect

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Note Veeva ePRO is only available to sites conducting a study whose sponsor is utilizing Veeva ePRO in a Clinical Vault.

Overview

You can export survey response, adherence, and audit trail data for your study in Study Connect. Below is a brief description of each export:

• Survey Data: Downloads all submitted participant responses for all surveys in your study. Use this export to review your participant’s responses to surveys. For more information, see the Survey Data Specifications section below.
• Adherence Data: Downloads all participant adherence data for your study. Use this export to see if ePRO surveys are completed, missed, or are currently available to participants. For more information, see the Adherence Data Specifications section below.
• Export ePRO Audit Trail: Downloads Study Connect user audit trail entries and MyVeeva for Patients participant audit trail entries related to ePRO for your study. For more information, see the Audit Trail Data Specifications section below.

To generate and export ePRO data, complete the following steps:

1. In Study Connect, select ePRO on the left menu.
2. On the Overview page, locate the Export section and select the data set you want to export.
3. Select Generate New. Once the export starts, it may take a few minutes before the file is ready.
4. When the export finishes, you receive an email and Study Connect notification with a link to the export. To view the notification, select the notification bell () on the ePRO Overview page and select the link in the related notification. The document viewer opens in a new window and the data export is displayed.
5. To download the file, select the download source file icon () on the upper-right corner of the page. The file begins downloading.

To download your latest exported ePRO data, complete the following steps:

1. In Study Connect, select ePRO on the left menu.
2. On the Overview page, locate the Export section and select the data set you want to export.
3. Select Download. The file begins downloading.

Survey Data Specifications

Exporting survey data from Study Connect generates a .CSV file with the following data specifications:

Actual Column Heading	Description of Data
Study	The study name as it appears in SiteVault
Participant ID	The participant’s ID as it appears in SiteVault
Event Name	The name of the ePRO’s start event
Event Sequence	The sequence number of the ePRO’s start event
Survey Unique ID	The unique identifier of the completed ePRO
Survey Name	The official name of the ePRO
Survey Display Name	The patient-facing name of the ePRO
Question Unique ID	The unique identifier of this question
Question Number	The question number of this question
Question	The question text
Question Type	The type of question Options include Single Choice, Visual Analog Scale, and Numeric Rating Scale
Answer	The answer text entered or selected by the user
Language	The language the ePRO was displayed in at the time the participant submitted the ePRO
Start Time (UTC)	The UTC datetime when the ePRO was started by the participant
Completion Time (UTC)	The UTC datetime when the ePRO was submitted by the participant
Completed By	Who completed the ePRO This field always populates as STUDY SUBJECT.

Adherence Data Specifications

Exporting ePRO adherence data from Study Connect generates a .CSV file with the following data specifications:

Column Heading	Description of Data
Study	The study name as it appears in SiteVault
Participant ID	The participant’s ID as it appears in SiteVault
Event Name	The name of the ePRO’s start event
Event Sequence	The sequence number of the ePRO’s start event
Survey Unique ID	The UUID of the completed ePRO
Survey Name	The ePRO’s name as defined in the ePRO collection at the time the participant submitted the ePRO
Survey Display Name	The ePRO’s patient-facing name as defined in the ePRO collection at the time the participant submitted the ePRO
Adherence Status	The adherence status of the ePRO Options include Available, Compliant, Late, and Missed
First Available Datetime (UTC)	The UTC datetime when the ePRO first became available to the participant
Due Datetime (UTC)	The UTC datetime when the ePRO was due for the participant
Start Datetime (UTC)	The UTC datetime when the participant started the ePRO If the ePRO is missed and never started, this field doesn’t populate.
Completion Datetime (UTC)	The UTC datetime when the participant submitted the survey If the survey is missed, this field doesn’t populate.
Time Zone	The time zone of the participant at the time they submitted the survey If the ePRO is missed, this field doesn’t populate.
Completed By	This field always populates as Study Subject.
Platforms	The MyVeeva for Patients application platform the participant used to submit the survey Options include Android, iOS, and Web
Language	The language the ePRO was displayed in at the time the participant submitted the ePRO

Audit Trail Data Specifications

Exporting ePRO audit trail data from Study Connect generates a .CSV file with the following data specifications:

Actual Column Heading	Full Name of Column Heading	Description of Data
study_name	Study Name	The study name as it appears in SiteVault
user_id	User ID	The SiteVault or MyVeeva for Patients user ID of the user who performed the action
action_performed_at	Action Performed At (Time)	The time when the action was performed
audit_action	Audited Action	The action being audited Examples include CONNECT_EPRO, EXPORT_SITE, and NEW_PARTICIPANT_EVENT
event_description	Description of the Audited Event	Full description of the audited event Examples include Site Study Connected to ePRO, Site Study Data Exported, and Triggered New Participant Event
item_name	Name of the Audited Item	The name of the item being audited Options include STUDY and PARTICIPANT
item_id	Unique Identifier of the Audited Item	The unique identifier of the audited item
item_data	Human-Readable Description of the Audited Item	The referenced data within the item being audited Examples include FEZZIK-07 : ePRO Collection v1 and FEZZIK-07 : 00001 : Dose 1
field	Field on the Audited Item	The referenced field within the item being audited If no field exists, this populates as null. Examples include supported_languages and actual_datetime
old_value	Old Value of the Field	The old value of the referenced field within the item being audited If no old value exists, this populates as null. Examples include “English” and “2022-08-16T12:34:30Z”
new_value	New Value of the Field	The new value of the referenced field within the item being audited If no new value exists, this populates as null. Examples include “Japanese” and ““2022-08-16T15:00:00Z”
reason_for_change	Reason for Change	Contains the reason for a data change This field only populates if a data change is requested by your site and processed by Veeva.

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Managing Participant Event Dates and Times

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