Note Veeva ePRO is only available to sites whose sponsors are using Veeva ePRO in Clinical Operations.
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 surveys are completed, missed, or are currently available to participants. For more information, see the Adherence Data Specifications section below.
- Export Audit Trail: Downloads Study Connect user audit trail entries and MyVeeva for Patients participant audit trail entries related to surveys for your study. For more information, see the Audit Trail Data Specifications section below.
To generate and export survey data, complete the following steps:
- In Study Connect, select Surveys on the left menu.
- On the Overview page, locate the Export section and select the data set you want to export.
- Select Generate New. Once the export starts, it may take a few minutes before the file is ready.
- 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 Surveys Overview page and select the link in the related notification. The document viewer opens in a new window and the data export is displayed.
- 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 survey data, complete the following steps:
- In Study Connect, select Surveys on the left menu.
- On the Overview page, locate the Export section and select the data set you want to export.
- Select Download. The file begins downloading.
Survey Data Specifications
Exporting survey data from Study Connect generates a .CSV file with the following data specifications:
Full Name of Column Heading |
Description of Data |
Row ID |
The unique identifier of the row in the data export |
Study ID |
The study name as it appears in Clinical Operations Vault |
Participant ID |
The participant’s ID as it appears in SiteVault |
Event Name |
The name of the event from the collection that started the schedule for this survey |
Event Sequence |
The sequence number of the event from the collection that started the schedule for this survey |
Completed Survey Unique ID |
The unique identifier of the completed survey |
Survey Name |
The official name of the survey |
Study Survey ID |
The unique identifier of the survey in the study collection |
Survey Display Name |
The display name of the survey |
Question Number |
The question number of this question |
Question |
The question text |
Question Unique Identifier |
The unique identifier of this question |
Question Type |
- For survey questions, the type of question
- For calculated scores, score”
|
Question Method |
- or survey questions, the method by which the question was answered.
- For calculated scores, Score
|
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
|
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
|
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
|
Answer Label |
- Only populates for number entry questions
- The label of the number entry question’s answer field
|
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
|
Answer Name |
- Only populates for number entry questions
- The identifier of the number entry question’s answer field
|
Derived Flag |
- Populates as Y if the data was derived by a scoring calculation
- Does not populate if the data represents a survey question
|
Question Completion Time (UTC) |
The UTC datetime when the question was completed by the respondent |
Language |
The language the survey was displayed in at the time the respondent submitted the survey |
Start Time (UTC) |
The UTC datetime when the survey was started by the respondent |
Completion Time (UTC) |
The UTC datetime when the survey was submitted by the respondent |
Time Zone |
The time zone of the respondent at the time they submitted the survey |
Completed By |
- Who completed the survey
- This field always populates as PARTICIPANT or SITE STAFF.
|
Adherence Data Specifications
Exporting survey adherence data from Study Connect 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
- This field always populates as PARTICIPANT or SITE STAFF.
- 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 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 survey audit trail data from Study Connect 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, and UPVERSION_STUDY_SURVEY
|
Event Description |
- Full description of the audited event
- Examples include Collection created, Language added, and Study Survey up-versioned
|
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.
|