Capturing Data

Record study events and submit participant surveys

Managing Data Changes

Updating Survey Data

This option may be unavailable or limited to a certain timeframe based on how your study is configured. Contact your study sponsor if you are not able to update survey data and you think you should be able to.

If a survey contains restricted data, you are not able to view or update that data if you do not have permission to view it.

  1. On the participant’s page, select the event the survey is associated with.
  2. Select the completed survey you want to update. You may need to change the selection on the Display Surveys list to see the survey.
  3. Select Start Data Change from the Actions menu {Actions menu button}.
  4. Make all updates and enter the reason for the changes.
  5. Select Submit.
  6. In the confirmation that is displayed, select Continue to update the survey answers.

Viewing Survey Change History

  1. Open the survey.
  2. From the ellipsis menu {Actions menu button} select View History.
  3. Use the arrows at the top of the page to move between versions of the survey.
  4. For each version, you can also view the survey change history by selecting View Changes from the Actions menu {Actions menu button}.
  5. When you’re finished, select Close.

Omit Survey Data Collected in Error from Report

Note This option may be unavailable based on how your study is configured. Contact your study sponsor for more information.

  1. On the participant’s page, select the event the survey is associated with.
  2. Select the completed survey you want to remove. You may need to change the selection on the Display Surveys list to see the survey.
  3. Select Remove Survey from the Actions menu {Actions menu button}.
  4. Enter a Reason for Change, and select Submit.

The survey is displayed in the list with a line through the survey title and it will not be included in future reports.

Restoring Survey Data to a Report

  1. On the participant’s page, select the event the survey is associated with.
  2. Select a survey that has been removed that you want to add back to reporting. You may need to change the selection on the Display Surveys list to see the survey.
  3. Select Restore Survey from the Actions menu {Actions menu button}.
  4. Enter a Reason for Change, and select Submit.

The line is removed from the survey title, and it is included in any future reports.

Requesting Other Survey Data Changes

If you become aware of an error you can’t update yourself, you can submit a data change request to Veeva.

To submit a survey data change request to Veeva for other data, complete the following steps:

  1. Download the Veeva eCOA Data Change Request Form.
  2. Complete the form. Only one change can be requested per form. The following fields are required unless noted that they can be left blank. Fields may be left blank if they are not applicable to the change you’re requesting.
    1. Email Address Used to Access eCOA: The email address you use to log in to eCOA for the study.
    2. Study Sponsor: The company name of the sponsor or CRO that you are working on this study with. If you are unsure, you can look for the Company Name associated with your current eCOA system on your VeevaID Home page.
    3. Protocol Number: The identifier of this study. Look at the top of the page next to the eCOA logo.
    4. Site Number: The identifier of your site for this study. Look at the top of the page next to the eCOA logo and find the value in parenthesis
    5. Participant ID
    6. Event Name (if applicable): The event name of the affected participant event as it appears on your survey exports. If you aren’t changing any data related to a participant event, leave this field blank.
    7. Survey Unique ID (if applicable): To locate the survey unique ID, export Survey Data or Adherence Data and look beneath the Survey Unique ID column. See Running Reports for more information.
    8. Question Unique ID (if applicable): To find the question unique ID, export Survey Data and look beneath the Question Unique ID column. See Running Reports for more information.
    9. Current Value: The incorrect value that requires a data change exactly as it appears in the survey. If you are requesting the transcription of data, please attach the survey to the form with PII removed or obfuscated.
    10. New Value: The corrected value that the data should reflect.
    11. Reason for Change
  3. Print the form and have the study’s principal investigator or their designated representative sign it. It is your responsibility to store the signed paper form.
  4. Email the signed form to dcr@veeva.com with a title of eCOA Data Change Request. We’ll review your request and, if approved, process the change in our system. If we have questions, we will contact you through email. After we process the data change, we’ll send you a confirmation email.
  5. View the audit trail entries we provide you and export the survey data to verify that the change is correct. The exported data includes the updated data and an entry for the data change. See Running Reports for more information.
  6. If the change is correct, respond to the email to confirm it. If we don’t receive confirmation after three follow-up attempts, we’ll close the ticket.

Note

  • You can send multiple requests in the same email if it is more convenient. Each change request needs its own signed form.
  • Veeva will attempt to complete data changes within 20 business days. If the request is urgent and you need it to be completed sooner than 20 business days, please communicate a requested timeline and reason in your email.
  • Veeva’s turnaround time begins when we receive the request from you and ends when we send evidence of the change back to you for confirmation. The turnaround time may vary depending on how many changes you request, how urgent they are, and the amount of time required for support to triage the request.