Background/Architecture Outline - Web view.0 is compatible with Word . 2007, 2010, 2013. and . is...

Common Protocol Template Guidance for Use

About this GuideThis Guide is for use with the Common Protocol Template (CPT) CPT-Technology Enabled Edition- Version 3.0. It is provided to assist with set up and utilization of the technology enabled edition of the TransCelerate Common Protocol Template and associated Microsoft Word add-ins. The format of the training contains a mixture of text and graphics and is accompanied by a series of brief video clips. If additional guidance is needed from the TransCelerate Common Protocol Template Workstream, contact [email protected].

1. Background/Architecture OutlineTo create a single template applicable to all study phases and types, the CPT uses a modular approach to manage information. The Core Backbone establishes a common heading structure and recommended content applicable to all protocols, while content specific to participant type or disease area are separated into libraries. The disease area libraries contain recommended objectives and endpoints as well as disease-specific content to facilitate adoption of Therapeutic Area Data Standards.

To facilitate the user experience, manage the diverse information components, and enable reuse of content, the Technology Enabled CPT was created within the MSWord environment. Utilization of a metadata driven XML framework further facilitates content reuse and establishes the foundation for traceability and automation.

Key requirements listed below are achieved through native Word functionality (with the creation of customized add-ins and use of content controls):

A Microsoft Word template with XML backbone Instructional text displayed in a separate pane beside the document Linkage of library and core - automates importing library text in appropriate sections of the

protocol Reuse of content via variables for key protocol terms, automatically reflects edits in all

occurrences Ability to export key protocol terms and content, and ability to import into other tools Linkage of Objectives to Endpoints

Last Updated 29 April 2016Last Updated 29 Jul 2015

mailto:[email protected]?subject=CPT%20Feedback

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Common Protocol Template Guidance for Use2. Template Set up & Administration (Sponsor Level) InstallationInstallation should be able to be performed by the end user in most cases. Detailed installation instructions are provided along with system prerequisites in the CPT Installation Instructions. The installation of the Technology Enabled CPT is managed via “one click” installation capability found at the following location: http://www.transceleratebiopharmainc.com/assets/common-protocol-template/. Included in the package is a Prerequisite Utility that evaluates the user’s system configuration for compatibility. Note: Version 3.0 is compatible with Word 2007, 2010, 2013 and is not compatible with any Apple Operating system.

CustomizationCustomization – Core Backbone and Available LibrariesMany of the benefits of the Common Protocol Template stem from consistent use, which should enable a better user experience for key stakeholders (e.g., sites, IRBs, regulators). That being said, some degree of customization will be needed, including any changes necessary to align with company specific formatting standards and branding. Sponsors may also want to introduce disease area specific content in areas not yet addressed in the current version. The level of customization should be determined by any company who chooses to adopt.

Customization – Additional LibrariesThe ability to incorporate company-specific libraries is being developed for a future release.

http://www.transceleratebiopharmainc.com/assets/common-protocol-template/

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Common Protocol Template Guidance for Use3. User Orientation My Templates / CPT Templates Tab This customized storage location for the CPT Core Backbone is described in the CPT Installation Instructions and allows for easy location of the Core Backbone when launching a new document in MSWord. For example, when starting a new protocol from the template, Word 2010 users will navigate to File/New/My Templates/CPT Templates tab to launch the CPT Core Backbone if it was stored as instructed. For more details, consult the CPT Installation Instructions.

Navigation Pane By enabling the navigation pane in the “View” tab of Word, the user will be able to see an interactive TOC within the CPT that will allow easy navigation throughout the sections of the template.

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Common Protocol Template Guidance for UseData Sources PaneThe Data Sources Pane displays information related to the various libraries that are linked to the CPT Core Backbone. It displays appropriate instructional content as you navigate through the template as well as relevant library content for inserting into the draft document. Specifics of each component are in the box to the right and displayed in the screenshot below:

a. Filter Library List Box PanelDisplays the libraries that have been designated for use in the protocol.

b. Instructional Text Box PanelDisplays the instructional text associated with each first and second level heading of the template. Clicking within the content control of the heading will display the relevant instructional text here. Additionally, library-specific instructions will be displayed when navigating through the library content tree view.

c. Library Content Tree View PanelDisplays a tree view hierarchy of the available content from selected libraries for a particular area/content control within the template. The entries within this window represent the tree view structure for the selected libraries as a reference only, allowing the user to review how the library content is organized. When there IS relevant data to the content control, the window will show an additional tree view under the bolded heading of “Available Content”. Any available text will be bolded within the tree view as the user expands sections. Double clicking one of these bolded headings will insert that content into the document content control area.If a particular content control (represented in the template with “enter information here” prompts) does NOT have any related data in the selected libraries, only these first two references will be present.

d. Preview Text Box PanelDisplays the relevant content for review when the user single clicks on one of the bolded

Understanding the Data Sources Pane

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Common Protocol Template Guidance for UseCPT TabThe CPT Tab within Word appears upon installations of the customized CPT add-ins. Users should navigate to this tab in order to utilize the following customization elements described below and displayed in the screenshot: (though present in the user’s version of Word when working in any document, they will only be functional when working within the CPT Core Backbone template)

a. Add Variables – allows the users to insert content controls for common protocol elements that are regularly used in multiple places throughout a protocol. By inserting the content control and defining the element text, the user ensures that edits to those elements will be replicated consistently throughout the document wherever the same variable is in use.

See “CPTV1_AddVariablesButtonTrainingVideo.mp4”

b. Delete – Some content controls cannot be deleted using MS Word delete functionality because they may have related content controls or elements associated with them. For example, deleting an objective may render associated endpoint in orphaned state. Due to this reason, you need to delete content controls associated with variables such as these using the Delete option in the ribbon.

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See “CPTV2_DeleteButtonTrainingVideo.mp4”

c. Example Text Tools “Convert” – In the Example Text Tools sub menu of the CPT Tab, the “Convert” button will convert example text found in the document to plain text. There is a drop down menu that gives us the below 2 options under convert

i. Convert Example Text and Move Next – By selecting this option from the drop down, only one instance of example text will be converted to plain text and the curser will move to the next set of example text in the document.

ii. Convert All Example Text in Document– This selection in the drop down will convert ALL example text in the document.

d. Example Text Tools “Remove” – In the Example Text Tools sub menu of the CPT Tab, the “Remove” button will remove example text found in the document. There is a drop down menu that gives us the below 2 options under remove

i. Remove Example Text and Move Next – By selecting this option from the drop down, only one instance of example text will be removed and the curser will move to the next set of example text in the document.

ii. Remove All Example Text in Document– This selection in the drop down will remove ALL example text in the document.

e. Example Text Tools “Next” – The “Next” button will help us navigate through the CPT document and locate each instance one by one of example text.

See “CPTV3_ExampleTextToolsTrainingVideo.mp4”

f. Useful Links – The useful links contains a dropdown of links users may find helpful while working in the CPT template. Currently this is configured to show a link to CPT User Resources and a CPT Feedback form on the TransCelerate site.

See “CPTV4_UsefulLinksButtonTrainingVideo.mp4”

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g. About – The about button contains version information for each of the add-ins, log files, a section to manage templates for the CPT, and an advanced settings tab which helps control user access to administrative functions. Manage Templates –Through the “Manage Templates” section users have the ability to update

to the latest version of the CPT Template. For example, this is where you might have someone in your company who maintains template versions and manages the updates as they are released from TransCelerate. This person may store the template at an internal share point site or a local file location. A user could then populate the “Manage Templates” section with this information to update to the latest release from TransCelerate.

a. Upon expanding this section, populating the File URL text box, and clicking the “Check for Updates” option a user will be able to check for updates for the CPT Template. Once the template has synchronized a message will appear and a user will close the window and dialog box and be able to use the most current template.

b. The File URL text box may be populated by a CPT Template saved as a .DOTX or .DOTM file and by one of the below 2 ways:

i. A folder created on the user’s PC where updates are pulled down and stored from the TransCelerate site (Example: C:\Users\angelica.capper\Desktop ManageCPTTemplates\CPT-TechEnabled-V2.01.dotx)

ii. A URL in a share room site that contains the updates. Advanced Settings - Through the “Advanced Settings” section users will be able to control access

to the CPT Admin tab. The default for this option will be unchecked

See “CPTV5_AboutButtonTrainingVideo.mp4”

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h. Instructional Text – clicking on this icon allows the user to “toggle” the Data Sources Pane on and off

if desired.

See “CPTV6_InstructionalTextButtonTrainingVideo.mp4”

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Common Protocol Template Guidance for UseCPT Admin TabThe CPT Admin Tab within Word is established with the installations of the customized CPT add-ins. To view the CPT Admin Tab, users will need to click on the “About” button on the CPT Tab, go to advanced settings, and click the check box for “Show CPT Admin Tab”. Users should navigate to this tab in order to utilize the following customization elements described below and displayed in the screenshots: (though present in the user’s version of Word when working in any document, they will only be functional when working within the CPT Core Backbone template)

i. Manage Variables – this component will allow the creation/management of additional customized variables and will be addressed in a future release of the CPT.

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j. Export Data – allows the user to export the predefined elements in the protocol document into an XML format which could be consumed by other systems if desired. Detailed instructions can be found later in this training guide.

k. Import Data -- similar to the export, an external file’s data appropriately tagged with metadata corresponding to template content controls, could be imported to integrate those tagged elements into the CPT content controls. Use of this function is at the individual sponsor’s discretion.

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Common Protocol Template Guidance for Use4. Creating a New Protocol Create a New Protocol Document

1. Click on New > My Templates > CPT Templates > CPT Core Backbone (Word 2010) Consult CPT Installation Guide for specific path in Word 2013.

2. Save the file 3. If necessary, enable the Navigation Pane found in the View tab.

Configure Library Filters

See “CPTV7_ConfigureLibraryFilesTrainingVideo.mp4”

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1. Go to the Data Sources Pane. Click on the Filter funnel. Select libraries by dragging libraries from “Available Libraries” to the appropriate panel (e.g., Therapeutic Area panel or Participant panel).

The below libraries are the current libraries for Release 3 of the CPT: Participant Type LibrariesV2.1_CPT Library_Healthy Volunteer Master.docxV2.1_CPT Library_Patient Master.docx

Therapeutic Area LibrariesV2.1_CPT Library_Asthma Master.docxV2.1_CPT_Library_Diabetes Master.docx

Note: All other libraries listed are for historical purposes and should not be used when authoring a new CPT.

Note: Custom filter functionality will be addressed in a future release.

2. Click OK to create the protocol document using the libraries selected.3. If a user wishes to not use a Therapeutic Area, they can leave this box empty. A user will have to

select a participant type to utilize the template. If no Therapeutic Area or Participant Type is selected, a user will see the below message.

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5. Authoring the Protocol Accessing Instructional Text

See “CPTV8_InstructionalTextPaneTrainingVideo.mp4”

CPT Core Backbone instructional text is maintained in a file separate from the template and linked to content controls in each of the first and second level template headings where applicable. To access this instructional information:

1. Click on a Level 1 or Level 2 heading content control.2. Review the relevant instructional text in the Instructional Text Box Panel. If no instructional text

exists for a particular heading the Instructional Text Box Panel will be empty.

Additionally, there is instructional text embedded in various sections of the Therapeutic Area and Participant Type libraries. To access this instructional information:

1. Click on relevant Available Content Tree View headings (for example, within the Library Content Tree View Panel when the Diabetes TA Library is enabled, clicking on the Primary Endpoints/Hemoglobin H1C heading will surface related instructional information in the Instructional Text Box Panel)

2. Within the Tree View, as you begin to drill down through the levels, if more granular instructional details exist at each level, they will be displayed at the top of the Instructional Panel with each previous related level displayed and separated by ~~~~~~ so that all relevant instructions will be displayed at once.

Completing the Title PageIn order to utilize some of the variables for common protocol terms, they should first be entered on the Title Page.

1. Complete Title page fields: some of these fields are key protocol terms found in the Add Variables add-in, and are or can be used in other places within the document. For example, Protocol Title is repeated in the Synopsis. Once values are entered into the variables on the title page, the values will be replicated in any other occurrences.

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Common Protocol Template Guidance for UseNote: If you begin to enter content into the CPT before configuring the Library filters as described above, you will be prompted with a reminder message that at least a participant library needs to be selected. See screenshot below.

Formatting ConventionsAs you begin to work within the CPT, you will notice several styling conventions. These formatting conventions are described in the table below:

Type of Text

Description Format Style

Common Headings

Heading levels 1 and 2 which should not be altered or deleted (Indicate “not applicable” if that is the case.)

Black, Times New Roman, 14pt, Bold Heading 1, Heading 2

Suggested Headings

Heading levels 3 and beyond which are suggested but optional, intended to be customized if appropriate for the study

Black, Times New Roman, 14pt, Bold Headings other than Heading 1 and Heading 2

Common Text

Common language intended to remain consistent across protocols

Contained between <Start of Common Wording> and <End of Common Wording>

Black text, Times New Roman

Normal

Suggested Text

Suggested language to be used in optional sections, which can be deleted if not needed

Black text, Times New Roman Normal

Variable Text

Wording to be replaced dependent on individual study needs

[blue bracketed] The blue is the darker blue from Word “Standard Colors”. R:G:B of 0:112:192.)

Normal

Example Text

Example text to be removed by the author prior to publishing via an add-in

Arial, 10pt, Italic, green The blue is the darker blue from Word “Standard Colors”. R:G:B of

CPT_Example

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0:176:80.

Instructional Text

Instructional and guidance text intended to aid in authoring of the protocol in this template

Will appear in the Instructions Pane

Red, hidden text in any version not utilizing the technology enhancements (i.e., if provided without use of the instruction pane). Should be removed by the author prior to publishing

CPT_Instructional

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Common Protocol Template Guidance for UseDrafting Protocol ContentOnce the title page is completed, drafting of other protocol content can begin anywhere in the document. All areas where text is to be entered have been defined with content controls to “tag” sections of content for export into XML format (one of the powerful benefits of the Technology Enabled CPT). These content controls will turn gray when hovering the cursor over them. They may either contain a guiding statement such as, “Enter text here” or may have example text already populated in them. See screenshot below:

Once in the content control the user can type new text, append to existing content or delete sections as necessary. Once a section is complete, the user should also ensure that the appropriate style format is established (e.g. if deciding to utilize example text it should be converted to the appropriate “Normal” style desired in the final document.)

In addition to basic text entry in the CPT, there are specialized methods for utilizing the various content components of the CPT (e.g. Key Protocol Variables, Library content). These are described in more detail below.

Note: Users will be unable to add comments or view tracked changes in content controls that are ‘locked for editing’ from Microsoft word.

Using Variables for Key Protocol Terms (Content Controls)

See “CPTV9_VariableValueTrainingVideo.mp4”As described earlier, the CPT defines a number of Key Protocol Terms that are typically used multiple times throughout a protocol. By creating these as Intelligent Content Management Variables within the CPT Add-in Tab, the user can define them one time and use them throughout the document ensuring that subsequent editing is accomplished consistently throughout the protocol.

To insert a variable:1. Place cursor in the intended location for the variable content.

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2. Click on CPT tab in the Word tool bar.3. Click the down arrow next to “Add Variable” to expose the variable pick-list.

4. Click on the desired variable name to insert the Variable Content Control at the cursor location.5. Enter text into the content control if the variable has not previously been defined in the

document.

Several of the key protocol term variables allow the user to create multiple instances. An example is “Dose Formulation” which will allow the user to create ‘Formulation 1’, ‘Formulation 2’, Etc.

As described earlier, in addition to facilitating re-use of content and ensuring consistency throughout the document, content controls are the foundation for building traceability of content throughout the protocol (e.g. relationships with objectives & endpoints). To accomplish this, users will utilize the content control variables in conjunction with library content to build these relationships. These template behaviors warrant more detailed discussion below.

Accessing & Utilizing Library ContentThroughout the CPT various content controls have been linked to specific content within the Participant Type and Therapeutic Area libraries. As the user navigates into specific content controls where these relationships/mappings exist, the relevant library content is displayed within the Library Content Tree View Panel as described earlier in this document.

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Common Protocol Template Guidance for UseNote: When utilizing/inserting library text into various sections of the template, it is best to insert any library text first and THEN edit or add additional text as required. In certain cases, the insertion of library content could “wipe out” existing text if inserted after already drafting a section. This is possible when the inserted content is an image or table vs lines of text.

Updating Objective and Endpoints Table (Section 4)

See “CPTV10_ObjectivesEndpointsOverviewTrainingVideo.mp4”

When creating the Objectives and Endpoints table within the CPT, the author may draft new text entries or utilize standard content from the Therapeutic Area Library content. The entire table serves as a content control and each row in the first column will serve as its own objective. Every bullet point in the second column will serve as an endpoint that matches to the objective on the same row and relationships are established and maintained within the Key Protocol Variables utility. Screen shot below:

1. Go to Section 4 Objectives and Endpoints of the template and click inside the first row and first column of the Objectives and Endpoints Table. You will notice the entire table is a content control. In the example video, the Asthma Library is enabled so the Library Content Tree View Panel displays the available content hierarchy.

2. To the left of the screen, expand the Primary Objectives heading to display available content choices.

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3. Single click on one of the bold content descriptors. This will display the full content within the Preview Text Box Panel below the Tree View Panel.

4. Double click the bold content descriptor to insert the text for the first primary objective.

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5. Next, go to the first row and second column to add the first primary endpoint for the first primary objective. A user can do this by expanding the Primary Endpoints heading to display the available content choices, highlight and double click to insert the content into the location. To enter an additional endpoint simply click enter to add another bullet and insert the content from the available choices. (A user may also type out the desired endpoints)

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6. Next, add a row below to add another primary objective. A user may type out the desired objective or add from the available content in the library.

7. Repeat these same steps through the Secondary and Exploratory Objective table cells as needed.

8. As a user enters the objectives and endpoints in the table, the Add Variable button on the CPT tab contains all of our updates. If required a user would be able to add an entered objective or endpoint elsewhere in the CPT Template. On the CPT Tab click the “Add Variables” button and

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choose Primary Objective 2 and click. This will add a new content control for the second Primary Objective elsewhere in the document. *Note this Content Control will be read- only, as edits to the objective and endpoints are controlled through the Objectives and Endpoints Table in Section 4

9. As you establish the individual objectives and endpoints, the Variable Add-in generates the corresponding Endpoint Variables mapped to each objective. For example when you expand the

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Primary Endpoint variable at this point in the process, it already contains the objectives entered and the endpoints mapped showing accurate traceability.

10. If you would like to delete an individual objective or endpoint, simply delete the rows as appropriate.

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Updating Objective and Endpoints Table in Synopsis Section

See “CPTV11_ObjectivesEndpointsSynopsisTrainingVideo.mp4”

The objectives and Endpoints table that appears in the synopsis sections is generated from the table that is created in Section 4 Objectives and Endpoints of the CPT Template. When a user first opens the template the Synopsis section will appear as below:

After a user populates the Objectives and Endpoints Table in Section 4 they will follow the below steps to update the synopsis table:

1. After populating the Objectives and Endpoints table, the Library Content Tree View, displays a section entitled “Table Data” with the newly entered Objectives and endpoints.

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2. You will notice that the last level in the tree view is the endpoint mapped to an objective and may contain a checkmark. The checkmark will indicate whether an objective and endpoint combination will be entered into the synopsis table. By default, all primary endpoints will contain this checkmark and a user will have to double click the empty space next to each secondary objective they want to include in the synopsis table. Once the selections have been made a user will click the blue refresh button to update the synopsis table (the words “Processing” will appear). Upon completion of the update, the template will refresh and the cursor will relocate to the Synopsis section which will contain the selected objectives and endpoints represented in a summary table.

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3. Special Note: Every time a user edits /enters/exits the Objectives and Endpoints table in section 4, the default selection will occur. This means that a user will have to manually select the secondary objectives every time an edit is made if and update is needed for the synopsis table.

Exclusion Criteria List

See “CPTV12_AppendingExclusionContentTrainingVideo.mp4”Building the table of Exclusion Criteria is similar to how we build the Objectives and endpoints table in that the content controls are already embedded within the listing. Each content control is aligned with a category of exclusion criteria (Medical Conditions, Diagnostic Assessments, etc.) and multiple criteria can be inserted into the control. Each criteria that is inserted will append to the last text and numbering will automatically adjust. To create the Exclusion Criteria list:

1. Click in the content control for Exclusion Criteria/Medical Conditions. The available library content will appear in the Library Tree View Panel.

2. Navigate to the desired bold content descriptor. Single click to review and double click to insert into section.

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3. Repeat this process to insert all relevant criteria for the first section. (Notice the automated numbering)

4. Additional custom criteria can be drafted for Medical Conditions at this time.5. Move to the content control for the next Exclusion Criteria section and repeat the process.6. Repeat for all subsequent sections.

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Common Protocol Template Guidance for UseExporting & Publishing the Document

See “CPTV13_ExporToXMLTrainingVideo.mp4”

Variables and the content of certain sections tagged with content controls can be exported to an XML file. The XML file can be used to import the information into other software packages (Excel, etc.) Specific instructions for this capability are below:

1. Once you have completed authoring your protocol, navigate to the CPT Admin Tab and click the “Export Data” Button. (If you do not see the CPT Admin Tab go to the CPT Tab, Click on the “About” button, Go to Advanced Settings and check the box called “Show CPT Admin Tab”)

2. Select the namespace (Protocol or Variables) you want to export and then type or navigate to a location you want to save your export to. Then click export when completed. You will see the words “Export Completed” when you export is finished.

a. Protocol – selecting this option will allow users to export the data entered while authoring the protocol. For example, if a user enters objectives and endpoints, exclusion criteria, or Protocol Number these items will be populated in the export.

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b. Variables – selecting this option will allow users to export the variable definitions from the CPT template for the purpose of creating a different template. This is more of an administrative function for use if a user ever wanted to author a different type of document and utilize the same variables created in the CPT.

3. A dialogue box will appear as your export is exporting. You can open the XML in Internet Explorer to take a look at the data that has been exported.

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a. Exporting Protocol

b. Exporting Variables

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