Working with Study Data

Access reports, dashboards, and analytics to maintain compliance

Understanding Report Data

Select a report below to view the related definitions.

For more information on how to run a report, see Running Reports.

Standard Reports

Survey Data

This report contains the current data for all surveys. It also includes any derived scores associated with a survey.

Exporting this report generates a .CSV file with the data below.

Column Description of Data
Study The study number
Participant ID The participant’s ID as entered by the site
Event Label The label of the survey’s start event
Event Sequence The sequence number of the survey’s start event
Additional Schedule Detail Details of the schedule that made the survey available
Survey Unique ID The system-generated unique ID of this instance of the completed survey or survey part
Survey Group Unique ID
  • The system-generated unique ID of the parent survey.
  • Populates only surveys with multiple parts or respondents, otherwise null.
Survey The label of the survey
Survey Instance
  • The instance of the survey.
  • For As-Needed surveys, the instance number indicates the number of times it has been filled out.
Survey Display Label The display label of the survey
Question Sequence The question number of this question
Entry Instance
  • For sets of questions that can be repeated by respondents, this value is the instance of the entry of this repeating question.
  • Does not populate for non-repeating question sets.
Question The question text
Repeating Question Section Name
  • For sections with questions that can be repeated by respondents, this value is the name of the repeatable section.
  • Does not populate for non-repeating sections.
Question Type
  • For survey questions, the type of question
  • For calculated scores, “score”
Question Status
  • The status of the question
  • Populates as NOT DONE if the respondent selected an optional answer
  • Does not populate if the respondent 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
  • The value selected or provided by the respondent to answer a question.
    • For more information about interactive image answers, see the [Interactive Image Answers]/gr/ecoa/working-with-study-data/understanding-report-data/#interactive-image-answers">section.
    • For attachment questions, the filename is included.
  • 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 ID for the value selected or provided by the respondent
  • Answers that do not have an ID (eg. number scale value) are included as-is
Question Completion Time
  • The site datetime when the question was completed by the respondent.
  • Does not populate if the survey was transcribed. Note: If viewing in Excel, review the date format to make sure it is displayed how you expect. Otherwise it is displayed in a regionally expected format.
Language The language the survey was displayed in at the time the respondent submitted the survey
Start Time
  • The site datetime when the question was started by the respondent.
  • Does not populate if the survey was transcribed.
  • Note: If viewing in Excel, review the date format to make sure it is displayed how you expect. Otherwise it is displayed in a regionally expected format.
Completion Time
  • The site datetime when the survey was submitted by the respondent.
  • If the survey was transcribed, this is the original assessment datetime in UTC, as entered during the transcription. If an original assessment time was not provided, the time will be displayed as 00:00:00.
  • Note: If viewing in Excel, review the date format to make sure it is displayed how you expect. Otherwise it is displayed in a regionally expected format.
Time Zone
  • ePRO: The time zone of the respondent at the time they submitted the survey.
  • eClinRO: The time zone of the site at the time the site staff submitted the survey.
  • If the survey was transcribed, this is the timezone entered during the transcription.
Completed By
  • The user who completed the survey
  • The value of PARTICIPANT, CAREGIVER, or SITE STAFF is always displayed in this field.

Interactive Image Answers (QSORRES)

  • PainDETECT: For the PainDETECT interactive image, the answer is a label that refers to the region selected by the user. Labels are defined by Veeva. See eCOA PainDETECT Possible Answers for a comprehensive list of labels.
  • Joint Counts: For Joint Count interactive images, the answer is either Y (selected) or N (not selected) for the row that corresponds to a specific joint and laterality. See Joint Count 28, Joint Count 44, Joint Count 66, or Joint Count 68 for a comprehensive .CSV list of joint rows.

Participant Events

This report contains each participant event along with the corresponding entered event datetime.

Exporting this report generates a .CSV file with the following data:

Column Description of Data
Study The study number.
Site The study site number.
Participant ID The participant’s ID.
Event The label of the event.
Event Sequence The sequence label of the event.
Event Datetime
  • The datetime entered for the event.
  • Full timestamp without time zone.
  • Displayed in the timezone it was entered in.
  • Format: yyyy-MM-ddTHH:mm:ss
Populated By
  • The type of user who entered the event datetime.
  • User is populated if a user entered the date; otherwise the cell is blank.
Did Not Occur True is listed if it did not occur.
Scheduled Date When an event is tied to another event that needs to happen first, this is the calculated expected date.
Scheduled Window The number of days before and days after that comprise the scheduled window of availability. For example, -3/+2 days
Last Updated
  • The timestamp from the last update to the actual event datetime.
  • Displayed as a full timestamp without the timezone that it was entered in
  • Format: yyyy-MM-dd'T'HH:mm:ss
Time Zone The timezone of the site. For example, Eastern Time (UTC-04:00).

Participant Groups

The report is only available if the study has groups configured. This report shows the current groups each participant is assigned to.

Exporting this report generates a .CSV file with the following data:

Column Description of Data
Study The study number.
Site The study site number.
Participant ID The participant’s ID.
Participant Status
  • The participant’s eCOA status.
  • Options include ACTIVE or INACTIVE.
Group Type The group type.
Group The Group for the corresponding group type that the site assigned the participant to.

Compliance Data

This report contains a record for every survey with its related adherence status.

Exporting this report generates a .CSV file with the data below.

Column Description of Data
Study Number The study number
Participant ID The participant’s ID
Event Label The label of the survey’s start event
Event Sequence The sequence number of the survey’s start event
Additional Schedule Detail Details of the schedule that triggered the survey
Survey Type
  • The type of the survey
  • This field always populates as either ePRO Survey or eClinRO Survey.
Survey Unique ID The system-generated unique ID of this completed survey or survey part.
Survey Group Unique ID </ul>
  • The system-generated unique ID of the parent survey.
  • Populates only surveys with multiple parts or respondents, otherwise null.
    • </ul>
    Survey The survey’s label
    Survey Instance
    • The instance of the survey.
    • For As-Needed surveys, the instance number indicates the number of times it has been filled out.
    Survey Display Label The survey’s display label
    Assigned To
    • The role of the person responsible for responding to the survey.
    • The value of PARTICIPANT, CAREGIVER, or SITE STAFF is displayed in this field.
    Adherence Status
    • The adherence status of the survey
    • Options include AVAILABLE, COMPLIANT, INTENTIONALLY LEFT BLANK, LATE, and MISSED. Note: Reports with an adherence status of CANCELED are excluded from this report.
      • AVAILABLE: Survey is available for completion.
      • COMPLIANT: Survey was submitted before the due datetime. Transcribed surveys are also marked as COMPLIANT.
      • INTENTIONALLY LEFT BLANK: Survey was marked as intentionally left blank by the site.
      • LATE: Survey was submitted after the due datetime. This occurs if the respondent has the survey open when the window closes.
      • MISSED: Survey was not completed before the due datetime.
    Origin When the adherence status is COMPLIANT, this indicates whether the survey was completed electronically (SOURCE) or transcribed later (TRANSCRIBED).
    Transcription Datetime The UTC datetime when a transcribed survey was submitted.
    Transcription Reason The transcription reason the transcriber selected.
    First Available The site datetime when the survey first became available to the respondent
    Due Datetime The site datetime when the survey was due for the respondent
    Start Datetime
    • The site datetime when the respondent started the survey
    • Only populates if the survey was started
    Completion Datetime
    • The site datetime when the respondent submitted the survey
    • If the survey was transcribed, this is the UTC datetime when the assessment was entered. If a time is not provided, the time will be displayed as 00:00:00.
    • Only populates if the survey was submitted
    Time Zone
    • The time zone of the respondent at the time they submitted the survey.
    • If the survey was transcribed, this is the timezone entered during the transcription.
    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
    Completed By (Site User)
    • The username of the site user who completed the survey
    • Only populates for eClinRO surveys if the survey was submitted
    Platform
    • The application platform the respondent used to submit the survey
    • For ePRO surveys, options include Android, iOS, and Web
    • For eClinRO surveys, Web is displayed
    • 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

    Data Changes

    This report contains all data changes that were made after initial collection. Survey questions that have been changed or removed are included in this report.

    Exporting this report generates a .CSV file with the data below.

    Note The report includes data changed by the following actions:

    • Changing survey responses
    • Removing surveys
    • Restoring removed surveys

    Column Description of Data
    Study Number The study number
    Participant ID The participant’s ID
    Event Label The label of the survey’s start event
    Event Sequence The sequence number of the survey’s start event
    Additional Schedule Detail Details of the schedule which triggered the survey
    Survey Type
    • The type of the survey
    • This field always populates as either ePRO Survey or eClinRO Survey.
    Survey Unique ID The system-generated unique ID of this completed survey or survey part
    Survey Response Version The version of the completed survey. If applicable, this will be a value of 2 or higher, because the initial version does not count as a data change.
    Survey The survey’s label
    Data Change ID The ID for the data change.
    Entry Instance
    • For sets of questions that can be repeated by respondents, this value is the instance of the entry of this repeating question.
    • Does not populate for non-repeating question sets.
    Question The question text
    Method
    • For survey questions, the method by which the question was answered.
    • For calculated scores, “Score”
    Previous 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 entered by the user who performed the change
    Vault Username The username of the eCOA Vault user who performed the action
    Date Change Datetime (UTC) The site datetime of when the data change was made.
    Initial Completion Datetime (UTC) The site datetime when the respondent initially submitted the survey.

    Audit Trail Reports

    Non-Clinical Data

    This report contains all the audited non-clinical activities performed by site users and participants.

    Exporting this report generates a .CSV file with the following data:

    Column Description of Data
    Vault ID The ID of the eCOA Vault
    Study ID The ID of the study
    Study Name The study number
    Site ID The study site number
    Site Number The study site number
    Participant ID
    • The participant’s ID
    • Does not populate if action was not performed on a specific participant
    User ID The ID in eCOA Vault of the user who performed the action
    Vault Username The username in eCOA Vault of the site 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 ACTIVATE_PARTICIPANT, UPDATE_CONTACT, and SITE_DOWNLOAD_REPORT
    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 label of the item being audited
    • Examples include PARTICIPANT, USER, SURVEY, EVENT, and STUDY_SURVEY
    Item ID The ID of the audited item
    Item Data
    • The referenced data within the item being audited
    • Examples include Collection Version : 2.0 : Languages : en-US,fr-FR
    Field
    • The referenced field within the item being audited
    • Does not populate if no field exists
    • Examples include reviewed, licensed, and display_label
    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 change entered by the user who performed the change

    Clinical Data

    This report contains audited actions that involve creating, modifying, or removing clinical data.

    Exporting this report generates a .CSV file with the following data:

    Column Description of Data
    Vault ID The ID of the eCOA Vault
    Study ID The ID of the study
    Study Name The study number
    Site ID The study site ID
    Site Number The study site number
    Participant ID
    • The participant’s ID
    • Does not populate if action was not performed on a specific participant
    User ID The ID of the user who performed the action
    Vault Username The username of the site 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 ACTIVATE_PARTICIPANT, UPDATE_CONTACT, and SITE_DOWNLOAD_REPORT
    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 label of the item being audited
    • Examples include PARTICIPANT, USER, SURVEY, EVENT, and STUDY_SURVEY
    Item ID The ID of the audited item
    Item Data
    • The referenced data within the item being audited
    • Examples include Collection Version : 2.0 : Languages : en-US,fr-FR
    Field
    • The referenced field within the item being audited
    • Does not populate if no field exists
    • Examples include reviewed, licensed, and display_label
    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 change entered by the user who performed the change

    Criteria Check Reports

    Criteria Check Event Output

    These reports are only available if the study has criteria check events configured. Criteria check rule output reports are named based on the name of the criteria check event, and can be generated separately for each criteria check event. The report will contain data from each time a site user ran the criteria check.

    Exporting this report generates a .CSV file with the following data:

    Column Description of Data
    ID The system-generated unique ID of the row in the data export.
    Study The study number
    Global Study ID The unique ID of the study
    Site The study site number
    Participant The participant’s ID
    Event The label of the criteria check event associated with this rule output
    Rule Execution Datetime (UTC) The UTC datetime when the criteria check was executed.
    Rule Execution Datetime
    • The local datetime of the site where the criteria check was executed.
    • The timestamp includes the local offset from UTC.
    Time Zone The time zone of the site where the criteria check was executed. For example, Eastern Time (UTC-04:00).
    [Dynamic Columns: Rule Expression Calculation]
    • The report will include a column whose header value comes from the criteria name for each expression configured in the rule, for example max_temp.
    • If no data is available for a criteria, the cell will be left blank.
    • If a criteria name is changed, a new column will be added for it on the report.
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