Exporting ePRO Data

  • You can export three types of data from MyVeeva Studio:
    • Survey Data: Downloads all submitted responses for all surveys in your study as a .CSV file
      • Only available if your study has at least one survey that’s been completed by a respondent
    • Adherence Data: Downloads all adherence data for your study as a .CSV file
      • Only available if your study has at least one survey that’s been made available to a respondent
    • Audit Trail Data: Downloads MyVeeva Studio user audit trail entries and MyVeeva for Patients participant and/or caregiver audit trail entries as a .CSV file
  • Only one export per study can run at any time; additional requests are denied until the export in progress has completed.
  • Exports are included in the audit trail, with user-initiated exports showing who performed the export.

Exporting Survey Data on an Ad Hoc Basis

All users with access to MyVeeva Studio can export survey, adherence, and audit trail data on an ad hoc basis.

To request an export, complete the following steps:

  1. From the Collections list, select the Export Data menu in the upper-right corner.
  2. From the drop-down menu, select one of the following actions:
    • Export Survey Data: Downloads all submitted responses for all surveys in your study as a .CSV file
    • Export Adherence Data: Downloads all participant and/or caregiver adherence data for your study as a .CSV file
    • Export Audit Trail Data: Downloads MyVeeva Studio user audit trail entries and MyVeeva for Patients participant and/or caregiver audit trail entries as a .CSV file

Using a File Transfer Protocol (FTP) Connection to Automatically Transfer Survey Data

If you’re a Vault Owner, you can create an FTP connection to automatically transfer survey data from MyVeeva Studio.

Overview

  • Exports run as an automatic daily transfer with the option to request immediate ad hoc transfers as needed.
  • You can choose to export to one of the following locations:
    • Veeva Clinical Database Vault (CDB): Creating an FTP connection with a CDB Vault requires that your study’s site and participant records match in both the CDB Vault and the Vault connected to your study. For example, if a site connected to your study doesn’t match a site in CDB, the FTP upload will be successful, but the data isn’t visible in CDB because no matching record exists. CDB creates error logs in these instances.
    • External FTP: Use an external FTP of your choice. This option allows you to tailor your file names and zipped folder options.
  • Audit trail data can’t be transferred via an FTP connection.
  • If selected, External FTP exports can include a log.txt file containing the following information about each CSV file included in the upload:
    • CSV File Name
    • Extract Start Datetime
    • Extract End Datetime
    • Number of Records
  • Daily survey data transfers occur at 03:00 UTC.

Creating an FTP Connection

To create an FTP connection, complete the following steps:

  1. From the Collections list, select the Actions menu in the upper-right corner.
  2. From the drop-down menu, select Create Connection.
  3. In the FTP Connection pop-up, you can create either a CDB connection or an external FTP site connection using the following steps:
    • CDB: The CDB Connection switch is automatically enabled. To create a CDB connection, enter your CDB Vault credentials in the following fields:
      • Server URL: Provide your Veeva CDB URL.
      • Port: Not required for CDB connections.
      • Destination Folder: If you're a CDMS Vault Owner, enter your user folder as the destination folder (for example, uVaultUser123/workbench/). If you're not a CDMS Vault Owner, enter workbench/ as the destination folder.
      • Username: The username format is server+email. For example, if your Vault server is us.veeva.com and your email is user@veeva.com, enter us.veeva.com+user@veeva.com.
      • Password: Enter your Vault password and continue to step 4 below.
    • External FTP: Toggle the CDB Connection switch to off and enter the following information about the external FTP in the following fields:
      • Connection: The connection type. You can select FTPS or SFTP. This field is required.
      • Server URL: The FTP's URL. This field is required.
      • Port: The FTP's port. This field may or may not be required by your FTP site.
      • Destination Folder: The FTP folder path where the ePRO data is uploaded. If you don't enter a destination folder, we'll upload the data to the FTP's home directory.
      • Username: Your FTP site username. This field is required.
      • Password: Your FTP site password. This field is required.
      • Settings: Specify your preferred export settings. You can configure your filenames to include or tokens to include the exact date and datetime. Special characters and whitespace are not permitted.
        • Zip Together: Select to export all items into the same zipped folder.
        • Survey Data: Select to export survey data and name per your requirements. At least one data export must be selected.
        • Adherence Data: Select to export adherence data and name per your requirements. At least one data export must be selected.
        • Log: Select to include the log file described in the overview above and name per your requirements.
  4. Select Test Connection to test your connection with your credentials. The result shows either Passed or Failed. If your result shows Failed, confirm your credentials and try again.
  5. When your result shows Passed, select Submit.

Initiating a Transfer on an Ad Hoc Basis

Vault owners can initiate a transfer on an ad hoc basis.

To initiate an immediate transfer, complete the following steps:

  1. From the Collections list, select the Actions menu in the upper-right corner.
  2. From the drop-down menu, select **Run Now**.
  3. One of the following options will display:
    • If CDB Connection, confirm your intent to run the export.
    • If External FTP, confirm the following:
      • Files to include in the export
      • File names
      • To receive separate files or a single zipped file

Updating an FTP Connection

After you create an FTP connection, you can update the FTP connection information.

To update an FTP connection, complete the following steps:

  1. From the Collections list, select the Actions menu in the upper-right corner.
  2. From the drop-down menu, select Update FTP Connection.
  3. Follow the steps in the Creating an FTP Connection section.
  4. After you test your connection and your result shows Passed, select Submit.

Inactivating an FTP Connection

After you create an FTP connection, you can disable the FTP connection information. The initial connection details will be retained.

To inactivate an FTP connection, complete the following steps:

  1. From the Collections list, select the Actions menu in the upper-right corner.
  2. From the drop-down menu, select Inactivate Connection, Click Continue.

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.