![Demonstrates the “Initiate Study Build & Study
Build Design”
The Solution
Matteo logs in to the new platform to retrieve Alzheimer’s Study
– 3172020 and initiate the Study Design process.
Matteo builds the Protocol Title of the study based on hyperlinks
to prepopulated libraries and templates. He then defines the
Study Objective as follows: “To assess the effect of [study
intervention #1] on the ADAS-COG and CIBIC + scores at Week
[X] in participants with Mild to Moderate Alzheimer’s Disease.”
Matteo next enters the Study Masking Information,
Intervention, and Arms. For these categories, he chooses
Double Blind, Xanomeline, and High Dose respectively.
Matteo can select the Objectives and Endpoints for the study
using the standards managed and governed in the Objectives and
Endpoints libraries. Matteo selects the appropriate Objectives,
Objective Level and related Endpoints. For each Endpoint, the
appropriate visit Timeframes, Units and Biomedical Concepts are
selected from controlled standard metadata terms.](https://image.slidesharecdn.com/transceleratehackathonfinal-200420203844/85/Transcelerate-DDF-Hackathon-61-320.jpg)
Transcelerate DDF Hackathon
- 1. Digitizing Clinical Study Design April 2020 TransCelerate Hackathon
- 2. Ryan Tubbs Team Leader LinkedIn Vasu Ranganathan Business Processes LinkedIn Gerald Kukko Solution Architecture LinkedIn Tianna Umann Blockchain LinkedIn Brent Groom Interactive Demo LinkedIn Brian Nikonow User Experience (UX) LinkedIn Michelle Hendrickson User Experience (UX) LinkedIn
- 3. Agenda
- 7. Step 1 Step 2 Step 3 Step 4
- 8. New Study Covers P0 https://youtu.be/XbDvLgimJmE Study Builder Tutorial P0-P6 of the Study Builder https://youtu.be/AS2eqIw9BjM Basic Advanced - Using Microsoft Word, Deep dive Use Microsoft Word to Edit a Study and Manage Elements; Covers P3, L1, L2 https://youtu.be/axiciIquSOU Advanced - Library Management and Library Import Covers L5 https://youtu.be/4YRTi14_VtQ Advanced - Digital Library Metadata Management Covers L1-L4 https://youtu.be/_ZN4l72Q4OU Advanced - Library Creation and Management Covers L5 https://youtu.be/xjZTSEaaC8g Advanced
- 9. https://hackathon.intelinotion.com User Email Password Nancy Edge nedge@intelinotion.com 2019Rtpl Jon Planet jplanet@intelinotion.com 2019Rtpl Cam Mistry cmistry@intelinotion.com 2019Rtpl Bill Label blabel@intelinotion.com 2019Rtpl crih@microsoft.com
- 10. User Guide
- 11. User Story 1 – Study Build Navigation 2 – Data Access 3 – Export Protocol Content L1 – Manage Elements L2 – Manage Element Values L3 – Manage Element Relationships L4 – Manage Value Relationships L5 – Library Import User Story P0 – New Study P1 – General Protocol Info P2 – Study Objectives P3 – Study Endpoints P4 & P5 – Mandatory Elements and Manage Schedule P6 – Version Study
- 12. • Click My Workspace and the green plus in the top left of the screen • Choose a location PharmCo -> Xanomeline. Click Next • Enter a Study Name • Click the Default tab • Select the Study Id: LY246708 and select values for the other required fields • Click Save
- 13. • Choose a study • Click the Protocol Level Content tab • Click the pencil icon next to Protocol Title and choose the protocol level content • Choose Masking from the Study Masking Information tab • Configure Interventions and Study Arms from the respective tabs. • Notice the business rule relationship between the tabs • Click Add
- 14. • Choose a study • Click the Objectives & End Points tab • Click the pencil icon next to Select Objectives and choose an objective • Preview the Objective • Note Objectives are filtered by therapeutic area • Note the + Add Objective button • Note the red x to delete an objective • Click Add
- 15. • Choose a study • Click the Objectives & Endpoints tab • Click the pencil icon next to Select Endpoint and choose an Endpoint • Preview the Endpoint • Note the + Add Endpoint button • Note the red x to delete an endpoint • Click Add
- 16. • Choose a study • Click the Assessments and Activities tab • Select the Study Day type: Week • Select Biomedical Concept of Common for Screening, Treatment, and Follow-Up • Add visit schedule information using the + Add buttons • Click the sub tab of Assign/Assessments/Details • Notice the columns correspond to the visit schedule set on the prior screen • Notice the list of Activites/Assessments • Expand an activity and click the end point cell for one activity • Notice the list endpoints is returned from a manage
- 17. • Note the version information • Note the ability to move state between Approved and Draft • Note all saved versions are stored read-only
- 18. • Click My Workspace and select a study from the My Studies list • Left mouse click Actions menu option and click "Launch Study Builder" • Navigate through the tabs to familiarize yourself with the Study Builder
- 19. Validation steps Graph browser • Click Info Models > Expand Clinical > Protocol > Protocol Summary • Right mouse click and select View Model • Published REST API endpoints to data • Application includes a graph browser of elements and properties REST API • The REST API is proprietary IP. We can coordinate a demo for any who would like to observe the REST API in action
- 20. Export JSON • Launch a study builder • Click publish • Generate Study Design – Download JSON Export Library data (Stretch) • Click Libraries and select the Actions menu of any object • Choose Export/Import to download a CSV or Word file Info Model (Stretch) • Click Info Models and browse to any desired item • Right click and choose Export Set to download a JSON file Export Metadata catalog (Stretch) • Click Metadata and browse to any desired metadata item • Right click and choose Export Set to download a JSON file Generate and realtime edit of Docx (Stretch***) • Stretch accomplishments • Generate Protocol - Docx • CPT template
- 21. • Click Metadata • Expand Clinical > Study > Intervation Type • Choose Behavioral Therapy • Click Libraries • Double click EndPoints • Click "show all" icon in the top right • Note: The ability to set state • Try: Add new endpoint
- 22. • Click Metadata • Expand Clinical > Biomedical Concept > right click and select Add value • Click Libraries • Double click a library, such as Endpoints • Click the green + to add a new library element along with the values • Click in the state column and note the ability to change between draft and approved. (Note all rights are controlled via a governance model)
- 23. • Click Metadata • Expand Clinical -> “a topic” -> sub • Click the relationship manager icon at the top of the screen • Notice the list of subcategories and the ability to add or remove subcategories
- 25. • Ability to import all types of study content. Including: elements, relationships, and values • Application includes the ability to import from an external source like CDISC. • Click Libraries -> Endpoints -> … (Menu) -> Export/Import • Notice Export/Import for Endpoints, Objectives, Assessment Library, etc. • Click Metadata -> select a location -> Click the Export and/or import icon
- 26. Challenge
- 27. 1 3 2
- 28. 1 42
- 29. • Generate a JSON protocol document • HTML Preview of protocol doc • Edit the protocol document in either Word or Hackathon application
- 30. Underlying Magic
- 31. HTTPS Web Mobile EDC CTMS PPM Azure Search Service Azure Active Directory Azure Key Vault Azure Blob Storage Service Azure Postgres DB Service Azure Logic Apps Integration Service Core App Service Audit Service Caching Service Notification Service Client App Service Azure File Service Office 365 Co-Authoring & Collab. Service App DB Service Content Proc. Service Task Mgmt. & WF Service Azure Traffic Manager Azure Kubernetes Service Nginx Ingress Controller Azure Load Balancer Horizontally scalable, independently deployable, containerized micro services accessed via RESTful APIs deliver core study builder and design repository functionality. No/low code, serverless integration service enables rapid data mapping and routing of CDM-based protocol documents to downstream systems. Also enables inbound API-based integration of CDISC standards and study design data sources. Serverless, scalable, tiered data storage Highly secure secret & key management Single sign on & role- based access control Serverless, industry standard file storage Fully managed industry standard file share Scalable relational database as a service Modern Microsoft Word application extends Word authoring UX and tightly integrates micro services to enable structured protocol document co-authoring and collaborating. Modern Web UX provides full study builder and design repository administration as well as content authoring capabilities.
- 32. Constant advocate for end user. Acts as voice of user. Understand existing ecosystems. Evaluate development abilities. Satisfy business requirements Establish key performance indicators Help define MVP and future road map
- 33. Empathize Ideate Define • Understand the base requirements • Identify current pain points • Establish personas (who is using this product and why?) • Evaluate similar existing products to set baseline • Keep users at the heart of all activities • Define the problem based on research and not assumptions • Establish road map and user journey map • Create backlog of requirements based on MVP • Establish future goals for post MVP • Construct a saleable navigation solution • Group content to align with user’s mental model • Begin to explore visual language • Build wireframes to review with subject matter experts Prototype Validate • Build out flow document in Sketch to view how all pages interact with one another • Constructed InVision (high fidelity) prototype to test functionality with users • Evaluate how designs will align with development efforts and back end services Repeat • Conducted various levels of user testing ranging from actual developed coded to prototypes • Task-driven testing allows users to control the experience to gauge ease of use • User acceptance testing ensures design has fulfilled provided user stories
- 34. Wireframes
- 35. Technical Feasibility Vs Customer Value This activity compares the development effort against the benefit to the user for all features. It helps the team establish what an MVP looks like and provides focus on what needs to be specific tasks. Technical Feasibility Customer Value HighLow Low High User Stories MVP
- 37. Industry Standards & Best Practices Expected Behaviors & Recognizable Patterns Focus on Information Architecture Reduce User Cognitive Load Ensured we used functionality that aligns with Users' mental model. Helps encourage adoption and increases retention. Allows the user to quickly navigate in a logical flow. Presenting the user with grouped content and populating drop downs with relevant content
- 38. Clear visual indicators alerts user to what is required. Form field title’s are persistent at all times eliminating confusion. Selection summaries provide immediate feedback showing the user the selections made. “Help text” assists user in knowing what type of action they need to perform. (Select from drop down or populate with free text) Presenting the user with efficient enabled vs disabled state ”call-to-actions” or buttons informs them when the section is completed.
- 39. Provide the user with a “safety net” for potentially destructive actions. Align with the knowledge of green means “go” and red means “stop” makes it clear to the user the impact of each button. Easy control for adding and removing selections Operating within a modal suggests to the user that they have not navigated deep within any flow The user has the ability to expand open text fields to view additional text as opposed to scrolling within a small window.
- 40. Art of the Possible The possibilities of DDF are endless. This is our view of the future.
- 41. Our Future State Vision We hope you enjoyed test-driving our prototype! This interactive UI represents our unique vision for creating a standards-based end to end digital clinical trials workflow that is automated, seamless, and accelerates critical life-saving medicines to market. We believe the clinical trials industry is at a critical juncture. Now, more than ever, emerging technologies have the potential to transform the way drug trials are run. Just like taking the keys to a Porsche, technology is accelerating faster than ever and disrupting wide swaths of industry. One compelling new technology that has surfaced in recent years is Blockchain. Blockchain consists of a series of blocks in which each consists of a cryptographic hash of the previous block, a timestamp, and transaction data. By requiring a match between the user and the encrypted hash, this “distributed ledger” provides an immutable source of truth that is safe and hackproof. While Blockchain originated in the financial industry, a growing number of other applications are emerging across industries, such as in real estate, insurance, and asset management. Imagine for a moment the possibility of a Blockchain controlled Clinical Trial workflow that provides participants with immediate visibility into all study metadata, including protocol titles, objectives, amendments, import/export query logs, and more. Take it further and consider a Blockchain-controlled IRB board consent process: Clinical Study protocol is revised, and study site request a change to their consent. The change request is logged on the blockchain and triggers a notification to the IRB board The IRB board approves the consent change. The approval is logged on the blockchain. This triggers an event that notifies all the stakeholders of the change in the consent. Blockchain holds vast potential to transform clinical trials research. If you enjoyed our prototype, then you’ll love our vision of a digital ledger-based clinical trial workflow that accelerates the marketing of life-saving medicines.
- 42. https://youtu.be/ra19YBdajoc Covers the UX and underlying technology
- 44. Scenario #1 The immediate solution for visibility and communication regarding amendments will leverage blockchain technology to enable near real time visibility into amendments to the protocol. It will also give the team full transparency into the clinical trial lifecycle along with the ability to accelerate the overall workflow. Furthermore, regulatory, study sites, and other ecosystem stakeholders involved in the clinical trial will gain access to the end to end study data artifacts, approvals, and reports. The added benefit of the solution is the team is able to integrate blockchain as part of their existing infrastructure instead of a rip and replace solution. Report Patient Enrollment Data Collection Data Analysis Protocol Design Validation SOA EDC Protocol SAPCSR MetaData Ecosystem Amendment Reporting Visibility and Notification IRB Consent Change Request CRO Protocol Revision/ Amendment Stakeholder Network Consensus 1 2 3 4 A trusted shared, single source of data truth enables visibility of all stakeholders into process enabling efficiency in the revision, reporting, and approval of study trial documents. Modern technologies such as blockchain and automated study event notifications work together to accelerate the clinical research trial process. 1. Clinical Study protocol is revised, and study site request a change to their consent. 2. The change request is logged on the blockchain and triggers a notification to the IRB board 3. The IRB board approves the consent change. 4. The approval is logged on the blockchain which triggers an event that notifies all the stakeholders of the change in the consent which enables them to update their internal systems documentation
- 45. Scenario #2 Lydia, a clinical data scientist at Contoso, is leading the phase III clinical research trial submission for the new Alzheimer’s drug study. The company recently deployed a new solution called blockchain to accelerate the study design and protocol creation and provide more transparency and data sharing. The solution also enables her team to produce deliverables on activities that previously required input from the study design team. The new workflow now allows teams across the clinical trial stakeholder’s ecosystem to work in parallel. This new system not only allows users to quickly enter required trial information into the CT.gov website, it also offers seamless submission of the CTSD information to the appropriate health authority. Blockchain opens up the possibility of near real-time visibility, removes upstream data dependencies, while enabling parallel authoring to efficiently sync report and other data component deliverables . Thanks to blockchain technology, team authors can now share components and reports in a much more secure environment. Ecosystem Parallel Activities Trial Summary Report Report Patient Enrollment Data Collection Data Analysis Protocol Design Validation CT.gov Updates SOA EDC Protocol SAPCSR
- 46. Shared Clinical Research Study Data Private Data Process Private Data Process Private Data Process Private Data Process Private Data Process Analysis Publishing CRO Study Site(s) Pharma Sponsor . . . . . Health Authority Compliance Audit
- 47. ´ Off Chain Shared Data Process Consent change request Protocol Revision/ Amendment Stakeholder Network Consensus CRO 2 3 4 Shared Data Process CRO Pharma Sponsor Study Site(s) Data Analysis Patient Enrollment Data Collection Report meta data Protocol Design Validation SOA CSR Protocol SAP EDC Health Authorities 1
- 48. Shared Data Process IRB Pharma Sponsor Study Site(s) Data Analysis Patient Enrollment Data Collection Report Protocol Design Validation SOA CSR Protocol SAP EDC Health Authorities Stakeholders Shared Data Layer ( Blockchain Ledger) CT.gov Updates Trial Summary Report
- 49. Data Analysis Patient Enrollment Data Collection Report Generation meta data sources Study Protocol & Set up Validation SAP Protocol DM345 Final 1.0 SOA EDC CSR Protocol DM345 Inclusion/Exclusion Change The Blockchain Ledger Watcher monitors events occurring on the blockchain. Events reflect information relevant to individuals and systems. Events are captured and sent to the Consumer The Consumer delivers information regarding the data received from the Watcher to Data Storage where the Analytics Engine processes the information through ML/AI The ML/AI output is shared with the Intelligent Agent which communicates the information to the End Users with ability to populate updates to upstream/downstream processes. Blockchain Watcher 1 2 3 4 6 Shared Data Layer (Blockchain Ledger) Protocol TransCelerate Clinical Trial Intelligent Agent for automated Study Design build and support Intelligent Agent ML Reinforcement Learning Machine Learning AI Transaction Consumer The Sponsor Protocol team makes a change to the study inclusion/exclusion criteria The transaction (change) is recorded on the ledger The Blockchain Watcher service pushes the transaction message to the Transaction Consumer The Transaction Consumer sends the information to the Machine Learning engine The Machine Learning model processes the information the output is sent to the Intelligent Agent. The Agent alerts the SOA, EDC and SAP teams of the change and offers to update their inclusion/exclusion documentation. The teams can also ask the Agent to open up a line of communication with other team members or ask the Agent to schedule a meeting if they have any questions regarding the update. The Agent consumes any feedback and records the workflow for resolution of the update which is used for reinforcement learning to improve the systems accuracy. 1 2 3 4 5 6 5 7 7
- 50. Reviewer Network Consensus Blockchain LedgerIRB AppovalIntelligent Agent Inclusion/Exclusion Update Validated Update New Blockchain Transaction Notificatoin Approve Protocol Update IRB Approval Validated Approval 1 2 3 4 5 6 7 Stakeholders Shared Data Layer ( Blockchain Ledger) Shared Data Process CRO Pharma Sponsor Study Site(s) TransCelerate Shared Data Workflow leveraging Blockchain and ML/AI Health Authorities
- 51. IRB Approval Smart Contract 1. Section Owners submit section review 2.Site Consent Owner Updates any Change Request if required (Step 1 & 2 may repeat until reviewer signs off) 3. IRB board Approves Consent Section Enter your Site ID Site Admin Log in (public/private key) Choose an Action Generate Internal IRB Informed Consent Review Template Submit Approved IRB Consent Submit Adverse Event document Submit Protocol deviation document Submit IRB Informed Consent Amendment approval Informed Consent Template Builder Please choose your components PART I: Information Sheet Introduction Purpose of the research Type of Research Intervention Participant selection Voluntary Participation Information on the Trial Drug/Device/Therapy Procedures and Protocol Unfamiliar Procedures Description of the Process Duration Side Effects Risks Benefits Reimbursements Alternatives to Participating Add Another Section PART II: Certificate of Consent Participant Statement of Consent Illiterate Participant Statement of Consent Statement by the researcher/person taking consent Add another section Part I Section A Reviewer Part I Section B Reviewer Part I Section C Reviewer Part II Section D Reviewer Multi Center Clinical Web Portal IRB Board Clincal Trial Shared Ledger IRB Notification Clinical Trial Site Consent Owner Content Section A Reviewer 1. Section A Consent Review submission with Change Request 2. Consent owner Notification Distributed Ledger Watcher 4. Content Reviewer Notification IRB Section A Approval 3. Section A Update 5. Section A approval sign off TransCelerate Innovation for IRB Consent Approval Portal powered by Blockchain
- 53. Contoso Pharma is a fictitious biopharmaceutical company we created to bring our story to life. We're about to take you on a journey where you’ll meet Frank, Jane, Matteo, Ingrid, and Jocelyn – the five actors responsible for rolling out InteliBuilder. Contoso Pharma seeks to introduce their first Alzheimer drug to the public in over 17 years. Their previous drug failed to get approved after over 10 years in development and at a cost of over $2 billion USD. In order to close the gap in time and money in bringing its Alzheimer drug to market, Contoso Pharma realizes it needs to rethink the traditional methodologies surrounding how clinical trial studies are designed and delivered. To address this concern Contoso Pharma has elected to use InteliBuilder to streamline the process.
- 54. Demonstrates the “Master Library of Study Design Elements” The Problem Frank is a clinical content steward who works within the Clinical Standards Group at Contoso Pharma. Frank’s responsibility is to interact with various investigators across a number of institutional boards, including IRB and FDA, to develop the terminology and standards required for a comprehensive search strategy across multiple medical sources. He must continually verify the quality and integrity of data submitted for review, ensure it follows all industry standards, and be exacting enough to call out data inconsistencies and gaps in information. Frank is flustered by the cumbersome and archaic nature of his job – managing communications and emails across all players, checking online sources, cross-checking paper-based documentation. With modern technology, Frank dreams there must be a better way to “digitize” and automate the content management process for clinical trials research The Turning Point Frank gets a call from Matteo, Clinical Director, at Contoso Pharma who informs him that they are adopting a new, innovative Study Builder and Digital Repository that will make the process seamless. Frank is skeptical, but excited.
- 55. Demonstrates the “Master Library of Study Design Elements” The Solution Frank starts using the system and quickly finds that Libraries can be generated for creation and management of specific design elements in the clinical trial lifecycle. Metadata tags associated with the Library can be configured at the time of Library creation as Mandatory or Optional, so that any objects created or imported into the Library will be required to be tagged with these metadata values. Frank sees that various components managed in the Library can be configured for “Type of Reuse” such as “As Is” or “Verbatim, “Repurpose” or “Derivative.” This design enables downstream users to optionally edit them to provide additional control of standard terms and content based on the Library level controls placed on the design elements. This will help control consistency and quality of standardized data and content – while making Frank’s job much easier. Frank sets up a number of relevant reusable libraries for the Study Design elements that are tagged by applicable metadata such as Therapeutic area, including libraries for: • Objectives, End Points • Inclusion, Exclusion Criteria • Protocol Title
- 56. Demonstrates the “Master Library of Study Design Elements The Resolution Frank can’t believe how easy and powerful this solution is! He is particularly excited about the ability to import from external sources into the digital repository (such as TransCelerate libraries or CDISC). This will enable sponsors from regulatory agencies to login to the system and maintain and update the specific libraries across any number of Therapeutic areas, Indications, and other study parameters. Frank feels he is now better equipped to ensure that data will flow seamlessly from these design elements into the protocol and other relevant documents, as well as export for downstream systems such as CTMS. Frank calls up Matteo and says: “I’m sold!”
- 57. Demonstrates the “Study Build – Navigation” Feature The Problem Jane is the lead clinical scientist for the study. On the previous Alzheimers study, her and her team experienced months of setbacks and delays. She recalls having to triangulate between various compliance and regulatory agencies, patient rights, and an avalanche of paperwork. Completing the design swiftly and with predictability has always eluded her. She knows all to well that the processes to search, find, and verify sources requires considerable time to copy and paste from PDFs into the study trial templates. This quality control process is often very cumbersome and time consuming, not to mention considerably prone to errors. The Turning Point To address their key pain points and improve efficiencies, Jane’s manager, Matteo, has been leading an initiative on how to create a new streamlined process. She learns that the digital Study Builder will enable her team to build a clinical study with predefined agency/institutional or company defined templates and libraries based on a single source of truth. For example, the builder inherits correct metadata values from the Product such as Compound Number, Therapeutic Area, and Indication. It also is designed to prepopulate relevant data from a large number of institutional databases, saving the manager considerable amounts of time from cross-checking and copy/pasting sources Even before launching into this project, Jane has high hopes about the potential time savings this platform will introduce into her clinical trials workflow. But she also has some degree of apprehension. She hopes this works!
- 58. Demonstrates the “Study Build – Navigation” Feature The Solution Jane logs into the Study Builder, follows the directions, and navigates to the Business Object Navigator. She selects “New” from the drop-down to start building the study. The Study Builder is pre-populated with properties from the name of her experimental product “Wonderdrug!” Jane proceeds to fill in the specific metadata required: • Protocol Number • EudraCT Number • IND Number • Study Phase
- 59. Demonstrates the “Study Build – Navigation” Feature The Resolution Jane creates a new Clinical Trial study called Alzheimer’s Study – 3172020 and saves it in the database. Jane is impressed with how fast and seamless this went compared to the old “cut and paste” approach.
- 60. Demonstrates the “Initiate Study Build & Study Build Design” The Problem Now, let’s get to know Matteo, Director of Clinical Operations at Contoso. Matteo manages a staff of 20 people who are working on the Alzheimer drug clinical trial. Matteo is responsible for ensuring the successful completion of the trial protocols and that they operate according to the highest ethical and industry standards. Matteo is deeply concerned by the enormous time and cost of all the study design activities – generating clinical reports, connecting the right data to the correct protocols, and managing all upstream and downstream schedules, etc. Matteo would like nothing more than to create a Digital Data Flow – one that generates a “single source of truth” – for the end- to-end study process. The Turning point Matteo’s team has been working with TransCelerate to test out a new digital Study Builder and Design Repository. He’s eager to see it in action. His lead clinical scientist Jane has already kicked off the study named Alzheimer’s Study – 3172020. • • • •
- 61. Demonstrates the “Initiate Study Build & Study Build Design” The Solution Matteo logs in to the new platform to retrieve Alzheimer’s Study – 3172020 and initiate the Study Design process. Matteo builds the Protocol Title of the study based on hyperlinks to prepopulated libraries and templates. He then defines the Study Objective as follows: “To assess the effect of [study intervention #1] on the ADAS-COG and CIBIC + scores at Week [X] in participants with Mild to Moderate Alzheimer’s Disease.” Matteo next enters the Study Masking Information, Intervention, and Arms. For these categories, he chooses Double Blind, Xanomeline, and High Dose respectively. Matteo can select the Objectives and Endpoints for the study using the standards managed and governed in the Objectives and Endpoints libraries. Matteo selects the appropriate Objectives, Objective Level and related Endpoints. For each Endpoint, the appropriate visit Timeframes, Units and Biomedical Concepts are selected from controlled standard metadata terms.
- 62. Demonstrates the “Initiate Study Build & Study Build Design” The Resolution Matteo is impressed! Not only was this easy (and kind of fun) but he also has options for generating the study design: • Choose a new Design template as the starting point • Populated from a previous Study Design • Start from scratch, if user is defining the design elements for the first time Matteo chooses to select a template for the Alzheimer’s therapeutic area to use for the design, and next edits the Schedule of Assessments. This outlines the activities, a plan for administration of study treatment, and a list of assessments and procedures that are to be performed for the duration of the study.
- 63. Demonstrates “Document Protocol Generation for TransCelerate CPT” The Problem Meet Ingrid, the Medical Writer at Contoso Pharma. Ingrid oversees a staff of three other writers who are responsible for generating the company’s clinical studies and reports, including QC on all protocols, amendments, and administrative changes. On top of this, Ingrid must manage all upstream and downstream schedules for her team and guarantee that all content changes are imported to the company’s central database. Ingrid is stressed out because she spends so much time project managing her team that she hardly can keep up with content production, report generation, and QC. Most of the time it feels like she’s squeezing 25 hours into 24. It’d be great if she could leverage technology to create efficiencies in her content workflow and reduce authoring time while maintaining consistency and the same high standards. The Problem Ingrid has just learned from Matteo, her director, that the department a new digital Study Builder and Design Repository. They meet for a briefing and he shows her the new solution.
- 64. Demonstrates “Document Protocol Generation for TransCelerate CPT” The Solution Ingrid logs in to the new platform to start building out the auto insertion protocol for Alzheimer’s Study – 3172020. Her job is to ensure the study is reusing and auto-inserting the correct library content, and that the control of this content is based on the right library component policies. Ingrid must also verify that the design of each document maps correctly to the overall digital data flow. Ingrid edits the document protocol generation engine with templates that will be used to automate the Protocol Title for the Study Builder. By providing automated links to the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) templates, Study Managers will now be able to save considerable amounts of time in formulating titles to their studies.
- 65. Demonstrates “Document Protocol Generation for TransCelerate CPT” The Resolution Next, Ingrid builds in auto generation features into the remaining initial protocol design entities (Study Objectives, Endpoints, Assessments, Forms). These are based on the selected key attributes on the protocol record of Therapeutic Area, Indication, Study Phase, and Study Type. Ingrid will initially focus on auto generating TransCelerate CPT documents. However, in the near future she will be asked to migrate to auto-generating the draft eCRFs and other related downstream documents from a master set of common data elements. Additional industry standards on the agenda to be auto generated include CDISC, Clinical Trials.gov, EudraCT, and more. Ingrid sees many benefits of the auto-generation feature especially as it introduces Study Managers to early visualization of their work and facilitates early detection of errors or inconsistencies.
- 66. Demonstrates the “Study Design – Export” Feature The Problem Jocelyn is a biostatistician at Contoso Pharma and part of the team leading the Alzheimer drug study. She works on Jane’s team and is responsible for monitoring how the study is conducted and to ensure full integrity of the results for reporting and external validation. Much of Jocelyn’s time is spent writing research proposals and conveying her findings to pharma professionals and the broader scientific community. A painstaking component of Jocelyn’s work involves collecting, organizing, and cross-checking the study data against numerous medical databases to ensure her results are as accurate as possible. Much of this is process is very manual and tedious. The Turning Point Jocelyn is called to an important meeting with Jane and Matteo where she’s introduced to a new Study Builder and Design Repository. Could it be that her days of wrangling data are over??
- 67. Demonstrates the “Study Design – Export” Feature The Solution Jocelyn logs into Contoso’s new Study Builder and locates the saved Study Design components for the Alzheimer trial study initiated by Jane and built out by Matteo. The study can be exported in JSON or other formats for downstream uses to support the end-to-end digital dataflow. Jocelyn proceeds to publish the Study Design elements output in JSON format.
- 68. Demonstrates the “Study Design – Export” Feature The Resolution Jocelyn previews the JSON format export of the Study Design output. After a careful review, she is ready to import the data into the EDC and CTMS. Jocelyn is surprised by how easy it is to manage the Study Builder. She now has the ability to provide automated workflows to benefit other downstream users. Jocelyn has waited a long time for this and couldn’t be happier.