Exporting Survey, Adherence, and Audit Trail Data

Export survey-related data in Study Connect

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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:

1. In Study Connect, select Surveys 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 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.
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 survey data, complete the following steps:

1. In Study Connect, select Surveys 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:

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.

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