Understanding the Study Design Specification

The Study Design Specification (SDS) is a PDF document you can generate in Studio that details the configuration of your study. It includes the definition of the study settings, events, surveys, and logic for a specific collection version.

The SDS provides an accurate record of the study build at the time of generation. This document is not intended to be used as a requirements document for User Acceptance Testing (UAT).

Collection Version History

This section tracks the changes associated with the collection version.

Column	Description
Version	The major version (for example, 1.0) or the minor version if the collection is in a draft state.
Approval Date	The date the major version was approved. This field is left empty for versions still in a draft state.
Change History	A summary of the change reasons included since the version was created.

Related Topic: Working with Collections

Study Settings

This section lists global configurations and parameters for the study.

Resources

This table lists the resource files configured for the study.

Column	Description
Resource Name	The resource file name that is referenced throughout Studio.
Language	The language assigned to the resource.
Display Label	The text label displayed to the user.
URL	A clickable link that directs to the resource file.
Available to Participants?	Indicates whether the resource is visible to participants. Displays Yes or No.

Related Topic: Managing Resource Links

Data Changes

Survey Data Changes

These tables define whether users can modify data after submission. We display separate tables for ePRO, eClinRO, and Composite surveys.

Column	Description
Survey Name	The name and the display label of the survey.
Allowed?	Indicates whether data changes are permitted for the survey. Displays Yes or No.
Submission Window	The configured window of time after the survey submission that data changes are allowed. Displayed as N Days, for example, 7 Days.

Related Topic: Managing Survey Data Change Permissions

Transcriptions

This table defines whether users can transcribe survey data on behalf of a participant. We display separate tables for ePRO, eClinRO, and Composite surveys.

Column	Description
Survey Name	The name and the display label of the survey.
Allowed?	Indicates whether transcriptions are permitted for the survey. Displays Yes or No.

Related Topic: Managing Survey Data Change Permissions

Remove Survey

This table defines whether users can remove a completed survey that was collected in error from reports.

Column	Description
Survey Type	The category of survey. Displays one of the following options: ePRO, eClinRO, or Composite.
Allowed?	Indicates whether surveys of this type can be removed. Displays Yes or No.

Related Topic: Managing Survey Data Change Permissions

Requires Site Signature

This table details the requirements for Principal Investigator (PI) reviews.

Column	Description
Data Type	The category of data. The following types are included on this table: Transcriptions, Source ePRO, Source eClinRO.
Requires PI Review?	Indicates whether a review is required. Displays one of the following options: Yes, Only Surveys with Data Changes; Yes, All Surveys; or No.

• Signature Statement Type: Indicates which type of statement is displayed when PIs review data. Displays Default or Custom.
• Custom Statement: If used, the Custom Statement is displayed only in the source language.

Related Topic: Managing Site Signatures

Participant ID Format

This table defines the structure of participant identifiers.

Column	Description
Format	The required character format for the ID. For example, [@@]-[##]-[###].
Example Value	A sample ID that matches the configured format.

Related Topic: Managing the Participant ID Format

In-Person Access

This table details the configuration for in-clinic participant access.

Column	Description
Enabled	Indicates whether the participants can complete surveys while in clinic. Displays Yes or No.
Access Type	The method used to access the device. Displays one of the following options: Streamlined, Password authenticated, or empty.

Related Topic: Managing In-Person Survey Access

Study Details

This section provides general study information and participant grouping structures.

Column	Description
Description	The description that was added for the study.
Image URL	A clickable link to the image that is displayed for the study in MyVeeva for Patients. Typically a company or study logo.

Related Topic: Working with Collections

Included Supported Languages

This table lists all languages active in the collection.

Column	Description
Language	The name of the language in English.
Patient	Indicates whether the language is supported for MyVeeva users. Displays Yes or No.
Site	Indicates whether the language is supported for eCOA site users. Displays Yes or No.

Related Topic: Managing Study Languages and Translations

Groups

This table outlines the group types and specific groups defined in the study.

Column	Description
Group Type	The configured type used for the group.
Groups	A list of the specific groups that have been configured within this row’s group type.

Related Topic: Managing Groups

Events

This section lists all events configured in the study sequence.

Column	Description
Event Name	The event name that is referenced throughout Studio.
Event Label	The name of the event displayed to users.
Type	The type of this event, such as Scheduled Event, Unscheduled Event, or Criteria Check.
Sequence	The sequence number of the event.
Available When	The logic that determines when the event becomes available. Displays one of the following options: Always, When Criteria Check is Passed, or After Previous Event.
Populated By	The source that triggers the event date. Displays one of the following options: Sites, Rule, or API.
Protocol Expected Date	Details the following setting information if an anchor event is used: Anchor Event: The event label of the anchored event. Offset Days: The number of days after the Anchor Event that the event will occur. Default Event Time: Not shown when an event is populated by a rule. Automatic Datetime Population: Not shown when an event is populated by a rule. Visit Window: The preferred timeframe that was configured for the event. Displayed as the number of days before and after the default event time.
Groups	A list of groups the event applies to. Includes the group type and group name. If the event applies to all groups, displays All Groups.
Event-Triggered Group Assignment	Indicates whether the group is event-triggered. Displays Yes or No. On the next line, lists any new group types that need to be assigned during this event.

Related Topic: Managing Events

Schedule Visualization

Includes a link to the study schedule preview.

Related Topic: Previewing the Study Schedule and Surveys

Surveys

This section details every survey in the collection. It begins with an overview table that provides a high-level summary of all surveys, and is followed by detailed breakdowns for each survey.

Column	Description
Survey Name	The name of the survey that is referenced throughout Studio.
Display Label	The name of the survey displayed to users.
Type	The type of survey. Displays one of the following options: ePRO, eClinRO, Composite.
Respondents	The user type who completes the survey. For composite surveys, multiple user types are listed.
Sequence	The sequence number of the survey.
Restricted Data	Indicates whether the survey includes restricted data. Displays Yes or No.
Source	The origin of the survey. Displays one of the following options: Study Specific, Library, Veeva Library.

[Survey Display Label]

The following survey overview information is displayed:

• Preview: A clickable link that takes you to the survey preview.

• Domain: The domain the survey is configured in. Displays one of the following options: QS, FT, RS, or MK.
• As Needed Display Label: The As-Needed Display label if the survey has an As-Needed schedule associated with it.
• Respondent: The type of respondent who is responsible for answering the survey. For a composite survey, the respondents are included in a comma separated list.
• Reviewed: Indicates whether the survey has been reviewed. Displays one of the following options: Yes, No, or N/A
• Licensed: Indicates whether the survey has been licensed. Displays one of the following options: Yes, No, or N/A
• Respondent Burden: Indicates the anticipated difficulty level of the survey for the respondent. Displays one of the following options: Very Easy, Easy, Moderate, Hard, or Very Hard.

Related Topic: Configuring Surveys

Survey-Level Parameters

• Survey Type: Indicates the type of survey. Displays one of the following options: ePRO, eClinRO, Composite
• Survey Sub Type: Indicates the survey subtype. Displays one of the following options: Standard, Training, Diary
• Language Override: Indicates whether the default language settings should be overridden to allow a site to view the survey in a participant language. Displays Site or Patient.
• Label: The participant-viewable label of the survey.
• Description: The participant-viewable description of the survey.
• License Text: The license and copyright information.
• License Image: A clickable link to the license image.
• License Image Description: The description of the license image that can be read by screen readers.
• Review Prompt: Indicates whether a prompt is displayed at the end of a survey instructing the respondent to view their responses before submitting. Displays true or false.
• Additional Details: Any additional details or licensing information for the survey.
• Overt Navigation: Indicates whether navigation buttons are included as part of the survey experience. Displays true or false.

Related Topic: The Universal Survey Parameters section of the Understanding Survey Parameters page

Diary Settings

The following information is displayed when the survey has a subtype of Diary:

• Diary Label: The label that is displayed with the diary item on the To Do page.
• Action Label: The additional text that is displayed with the diary item on the To Do page.
• Description: The diary description that is displayed on the diary page.
• Show Responses: Indicates whether a participant can open and view responses to diaries they already submitted. Displays true or false.
• Summary Blocks: The block in this survey that is used to summarize the instance when it is referenced in other questions or previews to help users identify which survey it is.

Related Topic: The Universal Survey Parameters section of the Understanding Survey Parameters page

Questions

The following information is displayed for multi-part surveys:

• Part Name: The survey part name that is referenced throughout Studio.
• Part Label: The label of the part that is viewable by MyVeeva Users.
• Respondent: The type of respondent who is responsible for answering this part of the survey.
• Survey Type: The type of survey for this survey part. Displays ePRO or eClinRO

Related Topic: The Configuring Composite and Multi-Part Surveys section of the Understanding Survey Parameters page

All Section Parameters

The following information is displayed for all sections:

• Section Name: The section name that is referenced throughout Studio.
• Type: Indicates the section type. Displays one of the following options: serial, table, repeat
• Condition: The condition that causes the section to be displayed for the respondent when it evaluates to true.
• Heading: The participant-viewable heading that is displayed at the top of the section.
• Sticky Heading: Indicates whether the section heading will stay visible when the users scroll down the survey page. Displays true or false.

Related Topic: The Universal Section Parameters section of the Understanding Survey Parameters page

Repeat Settings

The following information is displayed for repeat section types:

• Question Number: The number that is displayed before the heading.
• Heading: The text that provides instructions for the set of repeating questions.
• Summary Block: The block in this section that is used to summarize the set of repeating questions when the user answers them.
• Minimum Entry: The minimum number of times a respondent must answer the set of repeating questions (entries).
• Maximum Entry: The maximum number of times a respondent can answer the set of repeating questions (entries).

Related Topic: The Universal Section Parameters section of the Understanding Survey Parameters page

Table Columns

The following information is displayed for table section types (one pair per table column):

• Heading: The participant-viewable heading that is displayed at the top of the table.
• Width: The width of the column. The sum of the widths across all columns has to be 1.

Related Topic: The Universal Section Parameters section of the Understanding Survey Parameters page

Question Block Information

This table details the configuration of every question block in a survey.

Column	Description
Question Number	The number assigned to the question.
Question Name	The question name that is referenced throughout Studio.
Question Type	The type of question. Displays one of the following options: Text, Single Choice, Multiple Choice, Number Scale, Visual Scale, Number Entry, Text Entry, Date Entry, Time Entry, Datetime Entry, Interactive Image: Pain Detect, Interactive Image: Joint Count, Link, Site Media.
Table Position	The position of the question if it is used in a table section. This column is hidden if no table sections are included in the survey or survey part.
Question Text	The heading or prompt text displayed to the respondent.
Response Configuration	Detailed settings for the answer format, such as codes, scores, and ranges. See the Related Topics below the table for more information on what responses can be configured for each question type.
Optional Answers	Lists choices like "Don't Know" and their associated scores.
Condition	The condition that has to evaluate to true before the question is displayed. This column is hidden if no conditions are included in the survey or survey part.
Validation	Checks applied to the answer to ensure validity. This column is hidden if no validations are included in the survey or survey part.

Related Topics:

• Configuring a Single Choice Question Type
• Configuring a Multiple Choice Question Type
• Configuring a Number Scale Question Type
• Configuring a Visual Scale Question Type
• Configuring a Number Entry Question Type
• Configuring a Text Entry Question Type
• Configuring a Date Entry Question Type
• Configuring a Time Entry Question Type
• Configuring a Datetime Entry Question Type
• Configuring an Interactive Image Question Type
• Configuring an Attachment Upload Question Type
• Configuring a Linked Survey Question Type

Export Mappings

This table shows survey data that has been mapped for export. A row is populated for each block in the survey that has at least one value mapped.

Column	Description
Question Name	Displays the Original name used throughout Studio and the Mapped export name.
Question Text (Heading)	Displays the Original question text and the Mapped export text.
Answer Name	Displays the Original answer name used throughout Studio and the Mapped export name.
Answer Text	Displays the Original answer text and the Mapped export text.

Related Topic: Configuring Export Mapping

Conditions

This table lists the logical conditions configured for the survey.

Column	Description
Condition Name	The condition name that is referenced throughout Studio.
Type	The type of condition. Displays Single or Compound.
Condition	The information used to build the logic statement. For example: Block: Q1 Operation: == Answer Type: Number Answer number: 20

Related Topics: Configuring Conditions

Validations

This table lists the cross-question validation functions used in the survey.

Column	Description
Validation Name	The validation name that is referenced throughout Studio.
Function	The formula used to validate the answer.

Related Topic: Configuring Survey Cross-Question Validations

Scores

This table details any scoring logic applied to the survey.

Column	Description
Score Name	The score name that is referenced throughout Studio.
Label	The participant-viewable label for the score.
Display	Indicates whether the score is displayed to the respondent. Displays Yes or No.
Function	The formula used to calculate the score.
Result	The condition and output value or text based on the result.

Related Topic: Configuring Scores

Schedules

This table outlines when the survey is available to respondents.

Column	Description
Schedule Name	The schedule name that is referenced throughout Studio.
Description	Text describing the purpose of the schedule.
Groups	The participant groups this schedule applies to.
Location	The location where the survey is taken. Displays Home or Clinic.
Events	The Start Events and End Events that trigger the schedule.
Configuration	The following configuration details: Timepoint Label: The label used to differentiate between survey submissions for surveys that are included in multiple schedules. Export Details: The additional schedule details that are included in adherence and survey data reports. Delay: The amount of time that the schedule is offset from the Start Event by. Available: The availability type of the schedule. Displays one of the following options: For, Between, As Needed, Open-Ended. Also displays availability time or duration if configured. Partial Window: For As Needed and Between Schedules, defines whether or not the schedule will start when within a partial window. Displays true or false. Recurrence: The interval, frequency, and number of times the schedule is set to recur before it ends. For example, a survey that should be available for a MyVeeva user once a week for six weeks looks like this: INTERVAL=1;FREQ=WEEKLY;COUNT=6 Start Multiple: Indicates whether respondents can have multiple instances of a diary answer in progress at one time.

Related Topic: Configuring Schedules and Notifications

Notifications

This table lists the alerts sent based on the survey schedule.

Column	Description
Schedule Name	The schedule name that is referenced throughout Studio.
Notification Name	The notification name that is referenced throughout Studio.
Template	The message template used.
Type	The notification type. Displays one of the following options: Available, Due, Complete, Missed.
Recurrence	The following information that indicates how often the notification will repeat before the schedule ends: Interval: The number associated with the frequency. Frequency: The unit of time associated with the interval. Displays Daily, Weekly, or Monthly. Count: The number of times the notification should be sent. Default Delivery Time: The time of day for the participant when the recurring notification should be delivered, in 24-hr format.
Additional Configuration	The following information is included: Survey Part: For composite surveys, the survey part the notification is sent for. Offset: How far before the due date and time the notification should be sent. Number Missed: For notifications with a type of missed, the number of surveys that must be missed before the notification is sent.

Related Topic: Configuring Schedules and Notifications

Rules

This section details the automation rules configured for the study. The document displays expressions with line breaks to match the view in the Studio editor.

Survey-Based Notification Rules

These rules allow you to configure notifications to be sent when specific conditions are met.

[Rule Name]

These rules trigger notifications based on survey responses. The section includes a Variable Definitions table and a Notifications table.

• Description: The description of what the rule is for.
• Survey Reference: The reference for the survey that triggers the rule evaluation.

Variable Definitions Table

Column	Description
Variable Name	The name of the variable used in the rule expression.
Definition	The source data defining the variable.

• Preconditions: The preconditions that must be met before the system will evaluate the rule expression.
• Expression: The definitions of how the data in a rule should be evaluated. When an expression evaluates to True, the rule evaluation is triggered.

Notifications Table

Column	Description
Notification Name	The notification name that is referenced throughout Studio for this rule-based notification.
Recipients	The roles or email addresses that receive the message.
Title	The subject line of the notification.
Body	The body text of the message.
Restricted Data	Indicates whether the notification contains restricted data. Displays Yes or No.

Related Topic: Creating a Survey-Based Notification Rule Template

Criteria Check Rules

These rules evaluate participant data against defined criteria.

[Criterial Check Rule Name]

• Description: The description of what the rule is for.
• Criteria Check Event: The name of the event that triggers the check.
• Restricted Data: Indicates whether restricted data is included in the check. Displays Yes or No.

Variable Definitions Table

Column	Description
Variable Name	The name of the variable used in the rule expression.
Definition	The source data defining the variable.

• Preconditions: The preconditions that must be met before the criteria check can be run.
• Missing Preconditions Message: The message the system displays when the preconditions are not met.

Actions

• Section: The name of the criteria section, if applicable
• Hide from Site Users: Indicates whether the section is hidden from site users. Displays Yes or No.

Column	Description
Criteria Configuration	Displays the following information: Criteria Name: The name of the criteria that is used throughout Studio. Hide from Site Users: Indicates whether the criteria is hidden from site users. Displays Yes or No. Display Label: The user-understandable description of what the topic the criteria evaluation is answering.
Expression	The logic used to evaluate the criteria.

Conditional Actions

• Action Expression: Another expression that is run after the criteria check.

Column	Description
Action	The action that is taken when a conditional action expression evaluates to True. Displays one of the following options: Make Events Available, Trigger FTP Export, or API Call.
Action Details	Make Events Available: A list of events that become available. Trigger FTP Export: The names of the export jobs this rule is connected to. API Call: The following information is included: Call Name: The API Call Name Credentials: The connected credential label Field Mapping: The .JSON mapping information. Call Mapping: The API call mapping details below. Event Group Name: The event group name. Event Name: The event name. Form Name: The form name. Study Name (if populated): The study name. UAT Study Name (if populated): The related UAT study name.

Related Topic: Creating a Criterial Check Rule Template

Populate Event Rules

These rules automatically set the date and time for an event.

Populate Event Rules Table

Column	Description
Rule Name	The rule name that is referenced throughout Studio.
Description	Text describing the rule.
Variable Definitions	Includes the following information: Variable Name: The name of the variable used in the rule expression. Variable Definition: The source data defining the variable.
Survey Reference	The survey that triggers the rule.
Actions	Includes the following information: Selected Event: The event that is selected. Populate With: What time information the event is populated with. Displays one of the following options: Datetime, Date and Time, or Date. Depending on the populate option, the related following information is included: Datetime Datetime Reference: The datetime reference that the event is populated based on. Override Time: Included if rule is configured to override the time provided with survey data. Date and Time Date Reference: The date the event is populated based on, and the time in 24-hr format. Time Reference: The time reference the event is populated based on. Date Date Reference: The date the event is populated based on. Time: The time in 24-hour format.

Related Topic: Creating a Populate Events Rule Template

[Rule Name]

Description: The description of what the rule is for.

Survey Reference: The survey that triggers the rule.

Variable Definitions Table

Column	Description
Variable Name	The name of the variable used in the rule expression.
Definition	The source data defining the variable.

• Preconditions: The preconditions that must be met before system will evaluate the rule expression.
• Expression: The definitions of how the data in a rule should be evaluated. When an expression evaluates to True, the rule evaluation is triggered.

Actions Table

Column	Description
Start With	The trigger condition. Displays one of the following options: Survey Completion Datetime, Question Answer, Start Event Datetime.
Populate With	If it starts with a Question Answer, includes what time information the event is populated with. Displays one of the following options: Datetime, Date and Time, or Date. Depending on the populate option, the related following information is included: Datetime Datetime Reference: The datetime reference that the event is populated based on. Override Time: Included if rule is configured to override the time provided with survey data. Date and Time Date Reference: The date the event is populated based on, and the time in 24-hr format. Time Reference: The time reference the event is populated based on. Date Date Reference: The date the event is populated based on. Time: The time in 24-hour format.

Related Topic: Creating a Schedule Trigger Rule Template

Send Survey Data Rules

These rules trigger the API to send survey data to another system.

[Rule Name]

Description: The description of what the rule is for.

Survey Reference: The survey that triggers the rule.

Variable Definitions Table

Column	Description
Variable Name	The name of the variable used in the rule expression.
Definition	The source data defining the variable.

• Preconditions: The preconditions that must be met before the system will evaluate the rule expression.
• Expression: The definitions of how the data in a rule should be evaluated. When an expression evaluates to True, the rule evaluation is triggered.

Actions

Send Missed Surveys: Indicates whether missed surveys should also be sent. Displays Yes or No.

Column	Description
Action	The type of action that is taken when the expression evaluates to True. Displays API Call.
Action Details	The following information is included: Call Name: The API Call Name Credentials: The connected credential label Field Mapping: The .JSON mapping information. Call Mapping: The API call mapping details below. Event Group Name: The event group name. Event Name: The event name. Form Name: The form name. Study Name (if Populated): The study name. UAT Study Name (if Populated): The related UAT study name.

Related Topic: Creating a Send Survey Rule Template