Study Design report

In this report, you view all the settings specified for your study design, including a list of visits and forms in the study, kit and randomization information, and subject and supply settings.

This report contains only blinded information when run by blinded users and contains additional unblinding information when run by unblinded users.

Note:

If your study is designed to allow titrations, dispensing IoT-enabled devices managed with Oracle mHealth Connector or unscheduled visits, then this report also contains information about these particular features.

This report can save time and help you do your job more efficiently in a couple ways:

• Save time getting your study ready: If your organization has historically created a specification or synopsis based on the protocol, you might find that this report can take the place of the specification or synopsis.

  One key benefit that this report offers over the specification is that the report always reflects the details currently specified for the study design. If you update the study design, all you have to do is run the report again to ensure that the report is up to date.

• Save time before doing user-acceptance testing: Run the report before moving your study version to Testing mode is a great way to catch any mistakes you might have made during the study design process. Even with a complex study, the report is still useful for double-checking your settings. The report is a great way to make sure you added validation checks to questions, set up dispensation correctly, and more.

Modes

Available for the study design, and all 3 modes: Testing, Training and Production.

Permission required to run the report

Any user who's assigned the Run the Study Design Report permission can generate this report.

Filters

Filter	Description
Study Version	Choose the study version to run the report for.
Include in Report	Choose the data to include in the report.
File Type	Choose the output type for the report: HTML or PDF.

Field descriptions

Note:

Fields that don't have any corresponding values are marked as N/A in the report.

Initial fields	Descriptions
Customer Name	A customer's name used to purchase the cloud subscription.
Study Name	A study's ID as entered by the study manager when they created the study.
Mode	The mode in which you ran this report. For example, you may run a report in Testing mode to verify the data before going live with your study.
Version Created	The date that study version was created.
Study Version	Number of study version currently in the mode where the report is generated.
Report Generated By	User name of the user who generated this report.
Created Date	UTC time and date of the current generated report.
Version Modified	The date that version was modified.
Include in Report	Selection of data for running this report.

Study Design Summary	Descriptions
Visits & Events	Visits and events included in the study design.
Branch	Branches included in the study design.
Forms	Forms associated with each visit.
Kits Dispensed	Every kit type associated with each visit.
Randomization Design	Every randomization design associated with each visit.
Treatment Arms	Every treatment arm associated with each kit and visit.
Blinded Status	The type of kit, either Blinded or Unblinded for every visit.

Visits & Events	Description
Visit/Event Title	Title of each visit or event in the study.
Visit/Event ID	ID of each visit or event in the study.
Visit/Event Type	Indicates the type of visits or events: Screening, Randomization, Dispensation, Study Completion, Withdrawal, Event, or Adverse Event.
Required	Indicates whether each visit is required or not to continue participating in the study as a subject.
Shown in Timeline	How the visit will appear in the study. Future Only - All Scheduled Visit Types shows the visit only for subjects who did not progress past this date in the schedule. If this visit is part of a cycle then the visit is added only to future cycles. Future & Past - All Scheduled Visit Types shows the visit for all existing subjects in the study, including subjects who did not progress past this date in the schedule. If this visit is part of a cycle then the visit is added to all cycles in the study.
Scheduled From	Indicates the initial visit each visit is scheduled from.
Visit Schedule	Indicates when each visit should occur during the study. For example, a visit might occur after 30 days from when the Screening visit took place.
Visit Window	Number of days before or after the specified visit day in which the visit is allowed to take place. This includes if a warning or query is set up for visits happening out of window.
Last Modified	Last time the visit was modified in any way.
Last Modified User	User name of the user who performed the latest change (typically a study designer).

Branches	Description
Branch Title	Title of the branch created in the study.
ID	ID of each branch.
Cycle the Branch	Indicates whether the visits in the branch cycle or not.
Count of cycles	The number of times the visits in the branch are repeating throughout the study.
Starting Cycle Number	The number assigned to the first cycle of the branch.
Assign Subjects Using	Specifies the setting that was used to assign subjects to the branch: Treatment Arm or Form Question.
Treatment Arm Settings	Indicates the treatment arms that were selected when assigning subjects to the branch.
Form Question Settings	Specifies the Form, Question, Answers, and Visit that were selected when assigning subjects to the branch.
Visit/Event Title	Title of each visit in the branch.
Visit/Event ID	ID of each visit in the branch.
Visit/Event Type	Indicates the type of visit.
Required	Indicates whether each visit is required or not to continue participating in the study as a subject.
Scheduled From	Indicates the initial visit each visit is scheduled from.
Visit Schedule	Indicates when each visit should occur during the study. For example, a visit might occur after 30 days from when the Screening visit took place.
Visit Window	The allowed duration of a visit.
Last Modified	Last time the visit was modified in any way.
Last Modified User	User name of the user who performed the latest change (typically a study designer).

Unscheduled Visits & Events	Description
Visit/Event Title	Title of each unscheduled visit or event in the study.
Visit/Event ID	ID of each unscheduled visit or event in the study.
Visit/Event Type	Indicates the type of unscheduled visits or events: Adverse Event, Unscheduled Visit, Study Completion, Withdrawal or Event.
Required	Indicates whether each visit is required or not to continue participating in the study as a subject.
Not Before	The visit after which the unscheduled visit or event can take place.
Not After	The last visit before which the unscheduled visit or event can take place .
Last Modified	Last time the visit was modified in any way.
Last Modified User	User name of the user who performed the latest change (typically a study designer).

Forms	Description
Reference Code	Reference code added for the form (reserved for a future release).
Repeating Form	Indicates whether the form is repeating or not.
Allow Additional Rows	Indicates whether site users are allowed to enter additional rows to a repeating form.
Allow for Multiple Instances	Indicates whether site users are allowed to add multiple instances of the same lab form in a visit. This column only appears for lab forms.
Copied From	The study from which the form was copied
Copied Form Modified Date	The date when the copied form was modifi.ed by the study designer.
Form Name	This header row displays a form's name, as well as the Reference Code.
Question	Text of the question.
Questions Before the Table	Consists of standard non-repeating and all question types except for Label (Repeating Table Only).
Questions in the Table	Consists of repeating and all question types except for Question Groups.
Reference Code	Reference code added for each question (reserved for a future release).
Answer Type	The type of answer chosen for each question.
List of Values	Answer options shown for a drop-down question, a question with checkboxes or radio buttons, or instructional text. Also displays the code and description of code list items, if code lists are used for questions with multiple options for an answer. Be aware that instructional text answers are not displayed in PDF versions of the Study Design Report, and only appear in the HTML format.
Read Only	Indicates whether the question present in the form is a read-only item or not.
Advanced	Any advanced properties applied to a question such as Rollover Question, Coding Question, SAS Properties or Lab Normals Tag.
Validation Rules	Indicates whether the question contains any validation rules.
Rule Error	Shows the error message for any question that contains validation rules.
Action Rules	Indicates whether the question has a Show Question, Show Form, or Show Visit rule applied to it.
Properties	Properties applied to a question: Question Hint: Shows the question hint added for site users. Apply Change to Study Version: The study version to which a change made in the form applies. Required: Indicates whether the question is required or not to complete a form and a visit. Read Only; Indicates whether the question is read-only or not. Hidden: Indicates whether the question is hidden or not. Data Classifications: The Data Classification that was assigned to the question. Source Data Verification: The Source Data Verification property that was set for the question. Allow Future Date: Indicates whether or not a validation error is raised when a future date is entered for a Date/Time question type. A validation error is only raised when a future date is entered for a Date/Time question while this setting is set to Off.
Character Limit	Indicates whether there's a character limit, typically for a text or number question.
Format	Specifies the format details for each question: Format of the question, typically shown for Date/Number questions. Character Limit: Indicates whether there's a character limit, typically for a text or number question. Partial Date Allowed: Indicates whether a partial date is allowed as answer to a date/time type of question. Minimum Date Answer: Indicates the minimum allowed date format as specified by the study designer.
Partial Date Allowed	Indicates whether a partial date is allowed as answer to a date/time type of question.
Minimum Date Answer	Indicates the minimum allowed date format as specified by the study designer.
Last Modified	Last time the form was modified in any way.
Last Modified User	User name of the user who performed the latest change.
Logo	Indicates whether a logo has been added to the form, as well as the original name of the file uploaded as a logo.

Kits	Description
Kit Type ID	ID of each kit created for the study.
Description	Description of each kit created for the study.
Device Connection	Indicates whether a kit contains a connection to a device. For example, a smart watch or a heart monitor can have a connection to Oracle mHealth Connector.
Calculating Doses	Indicates whether the kit includes calculating doses or not.
Kit Type or Titration Group	Indicates the kit type or titration group sites can perform dose holds for.
Starting Visit	Indicates the visit where sites can begin performing dose holds for a specific kit type or titration group.
Starting Visit Cycle	The cycle where the starting visit applies.
Ending Visit	Indicates the visit where sites can stop performing dose holds for a specific kit type or titration group.
Ending Visit Cycle	The cycle where the ending visit applies.
Max per Subject	Indicates the maximum number of dose holds the site user can apply to the kit type or titration group.
Frequency per Subject	Indicates whether there is a limited frequency or timeframe the site user can perform dose holds for the kit type or titration group.
Distribution Settings	Indicates the type of distribution the kit has: blinded or unblinded.
Storage Temperature	A kit's ideal storage temperature to not damage it.
Type	A kit's type. For example, a kit can be a blister pack or a syringe.
Units Per Kit	Number of investigational product units in each kit.
Minimum Units to Ship	Minimum number of investigational product units that should be shipped to a site.
Last Modified	Last time the kit was modified in any way.
Last Modified User	User name of the user who performed the latest change (typically a study designer).

Calculated Doses	Description
Kit Type ID	ID of the kit type that includes calculated doses.
Calculated Dose Title	Title of the calculated doses as entered by the study designer.
Form for Calculated Dose	Form that contains the question used in a calculated dose.
Question for Calculated Dose	Question used in a calculated dose.
Visit Where Form is Collected	Indicates name of the visit that contains the form with a calculated dose question.
Selected Visit Where Form is Collected	The visit selected where form is collected for dispensing kits with calculated doses.
Precision for Each Dose	Number of places after the decimal point that the dose is calculated in.
Round Up For	How the dose calculation is rounded up according to dose precision.
Dosing Frequency	Number of doses a subject must consume.
Use Leftover Units in Next Dose	Indicates whether any remaining units after a dosing round can be consumed during the next dosing round or not.
Kit Measurement Value	Total numeric value for the product in the kit. For example, if a bottle contains 750 mg of pills, the value is 750.
Kit Unit of Measure	Informational field for a kit's unit of measure (for example syringe or sachet).
Subject Measurement	Value that determines the dose, along with the answer for the subject and the value of a single unit.
Subject Unit of Measure	Informational field for a subject's unit of measure (for example kg or kit).
Last Modified	UTC date of the last time this transaction was performed by a user.
Last Modified User	User name of the user who last performed this traction.

Kit Type Titrations	Description
Title of Dose Level	Dose level title assigned to each blinded kit type titration for down, up or maintain titrations.
Kit Type	Kit type of each kit included in a kit type titration.
Down Titration	Kit type used for each down titration.
Up Titration	Kit type used for each up titration.
Maintain Titration	Kit type used for each maintain titration.

Titration Settings	Description
Maximum Dose Changes	Maximum number for down or up titrations that site users are allowed to perform during a study.
Unscheduled Dose Changes	Dose changes that were made during an unscheduled visit.
Minimum Time Between Dose Changes	Minimum amount of time that should pass between each dose change.
Dispense when on Highest Dose and Site Wants Higher Dose	Indicates whether a site user is allowed to increase a subject's dose even though a subject is already on the highest dose specified in the study.
Message for Site Users	Displays a message for site users in case they do want to increase a subject's dose despite already being on the highest dose.
Dispense when on Lowest Dose and Site Wants Lower Dose	Indicates whether a site user is allowed to decrease a subject's dose even though the subject is already on the lowest dose specified in the study.
Message for Site Users	Displays a message for site users in case they do want to decrease a subject's dose despite already being on the lowest dose.
Dose Level	Displays the words used to describe a subjects' dose level without offering unblinding information.

Kit Dispensation	Description
Kit IDs or Kit Titrations	ID of each kit or title of each kit type titration associated with a visit.
Treatment Arm	Treatment arm associated with each kit in a visit.
Quantity	Number of kits associated with each visit.
Dispense Kits By	Indicates whether kits will be dispensed by lowest sequence number and closest expiration date or by kit number and closest expiration date.
DND (Days)	Minimum number of days before a kit's expiration date that the kit cannot be dispensed to a subject.
Dispense Outside Window	Indicates whether the kit can be dispensed outside the visit window or not.
Calculated Dose	Indicates whether the kit associated with each visit contains calculated doses or not.
Allow Titration	Indicates whether each visit allows dose changes or not during that time.
Last Modified	UTC date indicating the last time a kit's dispensation was modified in any way.
Last Modified User	User name of the user who performed the latest change (typically a study designer).

Exceptions	Description
Kit IDs	Indicates the ID of the kit with defined dispensation exceptions.
Location	Indicates the location of the dispensation exception. For example, Site specific:, followed by the site ID(s).
Exceptions	Indicates the visit(s) the dispensation exception is applied to, along with the amount of days it is set for.

Generated Kit Lists	Description
List Name	Name of the generated kit list as entered by the clinical supply manager.
List Type	Indicates whether the list is generated or uploaded.
First Kit Number	First kit number shown in the kit list.
First Sequence Number	First sequence number shown in the kit list.
Kits	ID of each kit included in this kit list.
Date Created	UTC date when the kit list was uploaded or generated.
Created By	User name of the user who generated the kit list (typically a clinical supply manager).

Randomizations	Description
Description	Description of the randomization design.
Blinded Status	Type of blind associated with the Randomization Design.
Cohort	Indicates whether the randomization design includes cohorts or not.
Randomization Type	Indicates the type of randomization design.
Re-Randomization	Indicates whether the randomization design allows re-randomization or not.
Treatment Arms Randomized or Mapped	The treatment arms included in the randomization design.
Assign New Randomization Numbers to All Subjects	Indicates whether subjects should receive new randomization number after they are randomized as part of a randomization design. Applicable only if Re-Randomization is enabled in the study's design.
Allow Randomization to Occur Outside Visit Window	Indicates whether or not a subject can complete a randomization visit even if they are outside of the visit window.
Restrict Randomization to Available Kit Types	Indicates whether the randomization is restricted to available kits in the inventory or not.
Last Modified	UTC date of the last time a randomization design was modified in any way.
Last Modified User	User name of the user who performed the latest change (typically a study designer).
New Treatment Arms	New treatment arms mapped in the study for randomization.
Previous Treatment Arms	Previous treatment arms that existed in the study for randomization.
Stratum Group	Name of the stratum group.
Stratum Question	Question that was used to stratify subjects.
List of Values	The values by which the subjects were stratified.
Range	The range used to stratify subjects.

Fields in each cohort (only appears if your study uses cohorts)	Description
Question	Question label used in a randomization design.
List of Values	Indicates the required answer for a drop-down question used in randomization design.
Range	Indicates the required answer for a Number or Age question used in randomization design.

Fields for treatment arms in cohorts	Description
Cohorts	Name of the cohort part of the randomization design.
Treatment Arms	Title of the treatment arms included in a cohort.
Ratio	Ratio entered for treatment or cohort in the study.
New Treatment Arms	New treatment arms mapped in the study in the context of a cohort or re-randomization.
Previous Treatment Arms	Previous treatment arms that existed in the study in the context of a cohort.

Generated Randomization List	Description
List Name	Name of the generated randomization list.
Type	Indicates whether the list is generated or uploaded.
Assigned Study Design	The study design version each randomization list is assigned to.
Multiplier for Blocks	Number of multiplier for randomization blocks.
Starting Number	Starting number in the randomization list that was generated in a study.
Length	Length of a randomization list. For example, 1000 rows.
Date Assigned to Mode	The date that the generated randomization list was assigned to the specific mode you ran the study design report in.
Date Unassigned from Mode	The date that the generated randomization list was unassigned from the specific mode you ran the study design report in.
Created By	User name of the user who created this randomization list (typically a randomization list manager).

Study Settings	Description
Setting	Name of the setting configured in the study, such as: Allow Subjects to be Manually Added Replace Subject Number with Randomization Number Allow Site to Select Subject Number Include Hyphen Between Site and Subject Number Leading Zeros in First Subject Number Subject Number Format First Subject Number Subject Numbering Withdraw Subjects After Code Break Limit Screened Subjects Screen Failed Subjects Allow Withdrawal for Subjects before Enrollment For more details about these settings, see Specify study, enrollment, and visit settings.
Value	Indicates the value set for each subject setting.
Last Modified	The date when each setting was configured.
Last Modified User	User name of the user who performed the latest change (typically a study manager).

Visit Settings	Description
Visit Type	Displays the type of visit: Screening, Randomization, Dispensation Non-Dispensation, Option, Withdrawal or Study Completion.
Site Enters Dates	Displays if a site user can enter a date for a specific visit type.
Site Edits Visit Dates	Displays if a site user can edit a date for a specific visit type.
Visit Can be Skipped	Displays if a visit can be skipped or not (Yes or N/A). Only applicable for dispensation and non-dispensation visits.
Visit Date Must Be On or After Randomization	Displays if the Visit Date Must Be On or after randomization (Yes, No, or N/A). Setting applicable only for the randomization visit type and it can only be set if a user just selects the setting Site Edits Visit Dates in Study Settings.
Visit Date Must On or After Dispensation	Displays if the Visit Date Must Be On or after dispensation (Yes, No, or N/A). Setting only applicable for dispensation visits and it can only be set if a user selects the Site Edits Visit Dates setting in Study Settings.
Send Visit Notification	Displays in which cases the visit notification is sent: Success, Success and Error, Error only.

Supply Settings	Description
Setting	Name of the setting configured in the study, such as: Inventory Schedule Settings Inventory Settings Shipment Settings For more details on what supply settings you can configure and display in the Study Design report, see Specify supply settings.
Value	Indicates the value set for each subject setting.
Last Modified	The date when each setting was configured.
Last Modified User	User name of the user who performed the latest change (typically a clinical supply manager).

Locally Sourced Kit Settings	Description
Kit Type	Kit type of each kit selected to be locally sourced.
Locally Sourced Countries	Indicates the countries selected for the kit types to be sourced from.
Sourced by Site Countries	Indicates the country of the sites selected whose kits can be locally sourced.
Last Modified	The date when each setting was configured.
Last Modified User	User name of the user who performed the latest change.

Source Data Verification	Description
Setting	Name of the setting configured in the study, such as: Allow SDV in Study Amount of SDV Allow SDV Overrides
Value	Indicates the value set for each setting.
Last Modified	The date when each setting was configured.
Last Modified User	Email address of the user who performed the latest change.
Source Data Verification Strategy	Name of the Source Data Verification strategy.
Subject Count	Number of subjects included in the Source Data Verification strategy: Initial Subjects and Remaining Subjects.
SDV Type	Type of Source Data Verification: All Questions or Critical Questions.
Last Modified	The date when each SDV strategy was configured.
Last Modified User	User name of the user who performed the latest change for the SDV strategy.

Signature Configuration	Description
Title	The title of the signature configuration, for example, Adverse Event Signature.
Required By	The role(s) required for the signature configuration.
Signature Text	The affidavit description selected for the signature configuration.
Required On	Indicates the type of signature configuration.
Required Form(s)	The name of the required form.
Required Visit(s)	The name of the required visit.
Required on Selected Visits	Indicates which selected visits a signature is required on. Note: This only applies to form level configurations. This field populates as N/A for visit level configurations.
Trigger by Question	Indicates the question and value(s) and whether or not a response to a question or form value prompts a signature request. Note: This field is populated with N/A for visits.
Trigger by Response	Indicates the question answer that prompts a signature request.
Target	Indicates the target date for the signature.
Email Notification	Indicates whether assigned users will receive an email notification on signature activity.
Date Created	Indicates the date the signature configuration was created.
Created By	The email address of the user who created the signature configuration.
Last Updated Date	The date in which the configuration was last modified.
Updated By	User name of the user who last modified the configuration.