Export ePRO-related data in SiteVault.
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, 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.
- Audit Trail Data: Downloads SiteVault 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 export these data sets, complete the following steps:
- On the study record page, select the ellipses menu (
).
- From the dropdown menu, select the action for the data set you want to export.
- Once the export starts, it may take a number of minutes before the file is ready. When the export finishes, you’ll receive an email and notification with a link to the export in SiteVault. Alternatively, you can navigate to Documents > Library and filter your library by Document Type = ePRO Export to locate the exported file there.
Survey Data Specifications
Exporting survey data from SiteVault 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 SiteVault 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 SiteVault 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.
|