Understanding Report Specifications

Select one of the following links to view the related specifications:

• Standard Reports
  • Survey Data Specifications
  • Compliance Data Specifications
  • Participant Events Specifications
  • Participant Groups Specifications
  • Data Changes Specifications
• Audit Trail Reports
  • Studio and Study Home Specifications
  • Site Non-Clinical Data
  • Site Clinical Data
• Criteria Check Reports
  • Criteria Check Event Output Report Specifications

Standard Reports

Survey Data Specifications

Exporting survey data from MyVeeva Studio generates a .CSV file with the data below.

Actual Column Heading	Full Name of Column Heading	Format	Description of Data
ROWID	Row ID	None enforced	The unique identifier of the row in the data export.
STUDYID	Study Label	Char(128)	The study label as it appears in eCOA Vault.
SITEID	Site ID	Char(128)	The study site number as it appears in eCOA Vault.
USUBJID	Participant ID	Char(128)	The participant's ID as entered by the site.
VISITNAM	Event Label	Char(100)	The label of the event from the collection that started the schedule for this survey.
VISITSEQ	Event Sequence	None enforced, typically Num(4)	The sequence number of the event from the collection that started the schedule for this survey.
SCHED	Additional Schedule Detail	Char(128)	Details of the schedule that triggered the survey.
QSCATID	Survey ID	None enforced	The survey's unique ID in eCOA Vault.
QSCAT	Survey Label	Char(100)	The official label of the survey.
QSINST	Survey Instance	None enforced, typically Num(4).	The instance of the survey. For As-Needed surveys, the instance number indicates the number of times it has been filled out.
QSCATCD	Study Survey ID	Char(36)	The unique identifier of the survey in the study collection.
QSCATDIS	Survey Display Label	Char(100)	The display label of the survey.
QSSEQ	Question Number	Char(255)	The question number of this question.
QSSPID	Repeating Question Entry Instance	Num(3)	For a block in a repeating section, this value is the instance of the entry of this repeating question. Does not populate for a block in a non-repeating section.
QSTEST	Question	None enforced, typically Char(2500)	The question text.
QSGRPID	Repeating Question Section Name	Char(100)	For a block in a repeating section, this value is the name of the section of the repeating block. Does not populate for a block in a non-repeating section.
QSTESTCD	Question Unique Identifier	Char(100)	The unique identifier of this question.
QSTYPE	Question Type	Char(100)	For survey questions, the type of question. For calculated scores, score.
QSMETHOD	Question Method	Char(100)	For survey questions, the method by which the question was answered. For calculated scores, Score.
QSSTAT	Question Status	Char(8)	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	None enforced, typically Char(100)	If the respondent selected an optional answer, the selected value. Does not populate if the respondent selected or provided a standard response.
QSORRES	Answer	Char(1500)	For question blocks, the value selected or provided by the respondent. For more information about interactive image answers, see the Interactive Image Answers section. For calculated scores, the score value and any text configured to appear with the score.
QSORRESU	Answer Label	Char(100)	Only populates for number entry questions. The label of the number entry question's answer field.
QSSTRESC	Answer Unique ID	Char(1500)	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	Char(100)	Only populates for number entry questions. The identifier of the number entry question's answer field.
QSDRVFL	Derived Flag	Char(1)	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)	date	The UTC datetime when the question was completed by the respondent. Does not populate if the survey was transcribed.
QSLANG	Language	Char(200)	The language the survey was displayed in at the time the respondent submitted the survey.
QSDTCST	Start Time (UTC)	date	The UTC datetime when the survey was started by the respondent. Does not populate if the survey was transcribed.
QSDTC	Completion Time (UTC)	date	The UTC datetime when the survey was submitted by the respondent. 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.
QSTZ	Time Zone	Char(200)	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.
QSEVAL	Completed By	Char(200)	The user who was intended to complete the survey. The value of PARTICIPANT, CAREGIVER, or SITE STAFF is displayed in this field.

Interactive Image Answers (QSORRES)

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.

Participant Events Specifications

Exporting participant events data from Studio generates a .CSV file with the following data:

Actual Column Heading	Full Name of Column Heading	Description of Data
Study	Site Study Name	The study name as it appears in eCOA Vault.
Site	Sponsor Site Name	The applicable site’s name as it appears in eCOA Vault.
Participant ID	Participant Study ID	The participant’s ID as entered by the site.
Event	Event Label	The Event Label from the event defined in ePRO Studio that triggered this survey.
Event Sequence	Event Sequence	The Sequence from the event defined in ePRO Studio that triggered this survey.
Event Datetime	Event Datetime	The site-entered Event Datetime. Full timestamp without timezone. Displayed in the timezone it was entered. Format: yyyy-MM-ddTHH:mm:ss
Populated By	Populated By	The type of user that entered the event datetime. Either System or User is populated.
Scheduled Date	Scheduled Date	When it has an anchor event, this is the calculated expected date.
Scheduled Window	Scheduled Window	The number of days before and days after that comprise the scheduled window of availability, as configured by the study builder. For example, -3/+2 days
Last Updated	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	Time Zone	The timezone that the event datetime was entered in. For example, Eastern Time (UTC-04:00)

Participant Groups Specifications

Exporting participant groups data from Studio generates a .CSV file with the following data:

Actual Column Heading	Full Name of Column Heading	Description of Data
Study	Site Study Name	The study name as it appears in eCOA Vault.
Site	Sponsor Site Name	The applicable site’s name as it appears in eCOA Vault.
Participant ID	Participant Study ID	The participant’s ID as entered by the site.
Participant Status	Participant Status	The participant’s status. Contains a value of Active or Inactive.
Group Type	Group Type	The Group Type as defined in ePRO Studio.
Group	Group	The site-selected group for the corresponding group type.

Compliance Data Specifications

Exporting compliance data from MyVeeva Studio generates a .CSV file with the following data:

Column Heading	Description of Data
Study Number	The study label as it appears in eCOA Vault.
Site ID	The applicable site's ID as it appears in eCOA Vault.
Participant ID	The participant's ID as it appears in eCOA Vault.
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.
Item Type	The type of the survey This field always populates as either eCOA Survey or eClinRO Survey.
Item Unique ID	The survey's unique ID.
Item Label	The survey's label.
Item Instance	The instance of the survey For As-Needed surveys, the instance number indicates the number of times it has been filled out.
Item Label	The survey's label.
Item Display Label	The survey's display label.
Assigned To	The role of the person responsible for responding to the survey.
Adherence Status	The adherence status of the survey Options include AVAILABLE, CANCELED, COMPLIANT, INTENTIONALLY LEFT BLANK, LATE, and MISSED: AVAILABLE: Survey is available for completion. CANCELED: Survey available but then was made not available due to site user action or the creation of a new study version. Scenarios include: The event that started the survey schedule had the date and time removed. The survey schedule was ended by another event. A new study version was activated with a change that affected the ongoing schedule. 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 submission type occurs in the rare scenario where the respondent has the survey open when the datetime passes and then submits it. MISSED: Survey was not completed before the due datetime.
Origin	When the survey status is COMPLIANT, this indicates whether the survey was completed electronically (SOURCE) or transcribed later (TRANSCRIBED).
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. 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.
Completion 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.
Transcription Datetime (UTC)	The UTC datetime when a transcribed survey was submitted.
Transcription Reason	The transcription reason the transcriber entered.
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 eCOA 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.

Data Changes Specifications

Exporting data changes data from Studio generates a .CSV file with the data specifications below. Survey questions that have been changed or removed are included in this report.

Column Heading	Description of Data
Study Number	The study name as it appears in eCOA Vault.
Site ID	The applicable site’s ID as it appears in eCOA Vault.
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 which triggered the survey.
Survey Type	The type of the survey. This field always populates as either eCOA Survey or eClinRO Survey.
Survey Label	The survey’s label.
Survey ID	The UUID of the completed Survey.
Survey Responses 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 Instance	The instance of the survey. For As-Needed surveys, the instance number indicates the number of times it has been filled out.
Survey Label	The survey’s official label.
Data Change ID	The identifier for the data change.
Entry Number	For a block in a repeating section, this value is the instance of the entry of this repeating question. Does not populate for a block in a non-repeating section.
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 “No”, “Easy”, 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.
Vault Username	The username of the eCOA Vault user who performed the action.
Date Change Datetime (UTC)	The UTC datetime of when the data change was made. Only populates if the survey was submitted.
Initial Completion Datetime (UTC)	The UTC datetime when the respondent submitted the survey. Only populates if the survey was submitted.

Audit Trail Reports

Studio and Study Home Specifications

Exporting Studio and Study Home audit trail data from Studio generates a .CSV file with the following data:

Column Heading	Description of Data
Vault ID	The unique identifier of the eCOA Vault.
Study ID	The unique identifier of the study in eCOA Vault.
Study Name	The study label as it appears in eCOA Vault.
User ID	The unique identifier of the eCOA Vault user who performed the action.
Vault Username	The username of the eCOA 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 label 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_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 a data change. This field only populates if a data change is requested by a site and processed by Veeva.

Site Non-Clinical Data

Exporting site non-clinical audit trail data from Studio generates a .CSV file with the following data:

Column Heading	Description of Data
Vault ID	The unique identifier of the eCOA Vault.
Study ID	The unique identifier of the study in eCOA Vault.
Study Name	The study label as it appears in eCOA Vault.
Site ID	The study site ID as it appears in eCOA Vault.
Site Number	The study site number as it appears in eCOA Vault.
Participant ID	The participant’s ID as entered by the site.
User ID	The unique identifier of the eCOA Vault user who performed the action.
Vault Username	The username of the eCOA 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 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, and SURVEY, 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 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 a data change. This field only populates if a data change is requested by a site and processed by Veeva.

Site Clinical Data

Exporting site clinical audit trail data from Studio generates a .CSV file with the following data:

Column Heading	Description of Data
Vault ID	The unique identifier of the eCOA Vault.
Study ID	The unique identifier of the study in eCOA Vault.
Study Name	The study label as it appears in eCOA Vault.
Site ID	The study site ID as it appears in eCOA Vault.
Site Number	The study site number as it appears in eCOA Vault.
Participant ID	The participant’s ID as entered by the site.
User ID	The unique identifier of the eCOA Vault user who performed the action.
Vault Username	The username of the eCOA 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 label 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_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 a data change. This field only populates if a data change is requested by a site and processed by Veeva.

Criteria Check Reports

Criteria Check Event Output Report Specifications

Exporting criteria check rule output data from Studio generates a .CSV file with the following data:

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 Label	The study label as it appears in eCOA Vault.
SITEID	Site ID	The study site number as it appears in eCOA Vault.
USUBJID	Participant ID	The participant’s ID as entered by the site.
VISITNAM	Event Label	The label of the criteria check event from the collection.
Rule Execution Datetime	Rule Execution Datetime	The UTC timestamp of the moment when the criteria check was executed.
Local Event Datetime	Local Event Datetime	The local datetime of the site user at the moment the criteria check was executed. This timestamp includes the user’s offset from UTC.
Time Zone	Time Zone	The time zone of the site user that was in effect when the criteria check was run.
[Dynamic Columns: Rule Expression Calculation]	[Rule-Based 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.