Understanding Report Specifications

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

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

Standard Reports

Survey Data Specifications

Exporting survey data from Study Home generates a .CSV file with the following data.

Actual Column Heading	Full Name of Column Heading	Format	Description of Data
ROWID	Row ID	None enforced	The system-generated unique ID of the row in the data export
STUDYID	Study Label	Char(128)	The study number in eCOA Vault
SITEID	Site ID	Char(128)	The study site number 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 survey’s start event
VISITSEQ	Event Sequence	None enforced, typically Num(4)	The sequence number of the survey’s start event
SCHED	Additional Schedule Detail	Char(128)	Details of the schedule that made the survey available
QSCATID	Survey ID	Char(36)	The system-generated unique ID of this instance of the completed survey or survey part
QSCATGID	Survey Parent Unique ID	Char(36)	The system-generated unique ID of the parent survey. Populates only for multi-part or composite surveys, otherwise null.
QSCAT	Survey Label	Char(100)	The 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 system-generated unique ID 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 ID of this question within the survey
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 the question Populates as NOT DONE if the respondent selected an optional answer Does not populate if the respondent 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 attachment blocks, the filename is included. 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 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
QSSTRESU	Answer Name	Char(100)	Only populates for number entry questions The unique ID 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. 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.
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 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.
QSDTC	Completion Time (UTC)	date	The UTC 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.
QSTZ	Time Zone	Char(200)	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.
QSEVAL	Completed By	Char(200)	The user who completed the survey The value of PARTICIPANT, CAREGIVER, and/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 in the MK domain, 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 Specifications

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

Actual Column Heading	Description of Data
Study	The study number in eCOA Vault.
Site	The study site number in eCOA Vault.
Participant ID	The participant’s ID as entered by the site.
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 that entered the event datetime. Either System or User is populated.
Scheduled Date	When it has an anchor event, 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 Specifications

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

Actual Column Heading	Description of Data
Study	The study number in eCOA Vault.
Site	The study site number in eCOA Vault
Participant ID	The participant’s ID as entered by the site.
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 Specifications

Exporting compliance data from Study Home generates a .CSV file with the data below. When exporting the report, you can select whether datestimes are in UTC or local time of where the data was collected.

Column Heading	Description of Data
Study Number	The study number in eCOA Vault
Site ID	The study site number 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 that triggered the survey
Item Type	The type of the survey This field always populates as either ePRO Survey or eClinRO Survey.
Item Unique ID	The system-generated unique ID of this completed survey or survey part.
Item Parent Unique ID	The parent survey’s unique ID. Populates only for multi-part or composite surveys, otherwise null.
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 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 (UTC)	The UTC datetime when a transcribed survey was submitted.
Transcription Reason	The transcription reason the transcriber selected.
First Available Datetime	The 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.
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 that completed the survey Only populates for eClinRO surveys 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	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 Specifications

Exporting data changes data from Study Home 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 number in eCOA Vault
Site ID	The study site number 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 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 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 “Yes”, “Moderate”, and “New Pain Survey”
Reason for Change	Contains the reason for a data change entered by the user that performed the change
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.
Initial Completion Datetime (UTC)	The UTC datetime when the respondent initially submitted the survey.

Audit Trail Reports

Studio and Study Home Specifications

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

Column Heading	Description of Data
Vault ID	The ID of the eCOA Vault
Study ID	The study ID in eCOA Vault
Study Name	The study number in eCOA Vault
User ID	The ID 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 type of item being audited Examples include COLLECTION, 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 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 change entered by the user that performed the change

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 ID of the eCOA Vault
Study ID	The ID of the study in eCOA Vault
Study Name	The study number in eCOA Vault.
Site ID	The study site number in eCOA Vault.
Site Number	The study site number in eCOA Vault
Participant ID	The participant’s ID as entered by the site 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

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 ID of the eCOA Vault
Study ID	The ID of the study in eCOA Vault
Study Name	The study number in eCOA Vault.
Site ID	The study site ID in eCOA Vault.
Site Number	The study site number in eCOA Vault
Participant ID	The participant’s ID as entered by the site 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 Specifications

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

Actual Column Heading	Description of Data
ID	The system-generated unique ID of the row in the data export.
Study	The study number in eCOA Vault.
Global Study ID	The unique ID of the study in eCOA Vault
Site	The study site number in eCOA Vault
Participant	The participant’s ID as entered by the site.
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.

Outbound API Reports

Outbound API Call Log Specifications

Exporting the daily API call log from Studio provides a technical record of all communication between Veeva eCOA and external systems. Each row in the log represents a specific event that triggered an API call. Logs will be empty if no outbound calls were made.

Column Heading	Description of Data
Internal ID	The unique ID generated for each log item
Execution ID	The ID that links the log to detailed log data
Instance ID	The ID that tracks data updates when information is changed or removed
Correlation Group ID	The ID of the rule group associated with the API call
Outbound Integration Config ID	The ID that identifies the credentials used for the outbound API integration
Study Participant ID	The unique internal study participant ID that is being used for the rule evaluation
Execution Type	The type of rule associated with the API call Examples include SURVEY and CRITERIA_CHECK
Status	The status of the API call Examples include PENDING, SUCCESS, MAPPING_FAILURE, EXCEPTION, and DISABLED
Call Type	The type of the API call Examples include EDC_UPDATE_FORM_DATA
Sponsor Study ID	The unique ID of the study in MyVeeva
Failure Reason	The response reason for API call failure
Created At (UTC)	The time the log was created at
Updated At (UTC)	The time the log was last updated
Resolved At (UTC)	The time the log call was completed