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.- 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:
|
Character Limit | Indicates whether there's a character limit, typically for a text or number question. |
Format | Specifies the format details for each 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. |
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:
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:
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:
|
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. |
Parent topic: Report descriptions