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Digital Data Flow

Frequently Asked Questions

DDF Initiative FAQ

What is the Digital Data Flow initiative?

The Digital Data Flow (DDF) initiative aims to modernize clinical trials by enabling a digital workflow that allows for automated creation of study content and configuration of study systems to support clinical trial execution. This initiative will establish a foundation for a future state of automated and dynamic readiness that can transform the drug development process.

Click here for a video describing DDF.

What is the objective of the DDF initiative?

The objective of DDF is to automate and expedite the Study Start-Up process by revolutionizing how data flows across clinical trial systems, beginning with upstream (e.g., study builder) and downstream (e.g., electronic data capturing/EDC, clinical trial management system/CTMS) clinical systems.

TransCelerate has collaborated to develop an open-source, vendor agnostic, study definition repository (SDR) reference implementation. The SDR's basis is a Unified Study Definitions Model (USDM), developed by CDISC, that standardizes the data model for protocol study definitions.

The SDR reference implementation enables the format of information from a digitized protocol and other sources to be standardized and stored centrally. This allows the information to be passed to systems through application programming interfaces (APIs) used for study execution and data collection and reused throughout the clinical development lifecycle.

In summary, DDF will combine data standards and a novel technology to enable the flow of data across all systems involved in the design and execution of a clinical trial.

Click here for a video describing DDF.

What are the benefits of the DDF initiative?

Digital Data Flow (DDF) benefits include:

- Minimized process hand-offs, data re-entry, and data format inconsistencies across study start-Up and execution

- A foundation for data exchange and interoperability between clinical technology systems, leading to greater compatibility among systems, flexibility to sponsors, and improved clinical trial efficiencies

- A more seamless flow of data leading to accelerated study start-up, and further enabling trials automation for sponsors and research partners

- Harmonization of the data format that can support greater interoperability and spark innovation within the R&D ecosystem and across the clinical trial solutions landscape.

Who does the DDF initiative help?

This initiative will assist many organizations, including pharmaceutical companies, CROs, standards organizations, upstream and downstream clinical vendors, sites, regulatory agencies, technology companies, and the open-source pharmaceutical and IT communities. With DDF, organizations across the R&D ecosystem will be able to leverage the open-source code of the SDR reference implementation and develop a framework to deploy their own SDR implementations.

Click here for a video describing benefits of DDF.

Who within a sponsor company is impacted by DDF?

Roles impacted by DDF would be study managers, study protocol authors, medical writers, data management stakeholders concerned with ensuring consistent use of standards, clinical systems (IT) stakeholders, data managers and clinicians primarily accountable for a study.

Click here for a video describing benefits of DDF.

DDF Long Term Success FAQ

What is the data standards solution and technology that will enable DDF?

Today’s manual processes with multiple human and technical hand offs are not a sustainable, effective way to approach clinical development. DDF envisions the digitization and automation of the flow of information to keep up with increasing demands of clinical development.

The DDF initiative involves a multi-faceted program that includes (a) collaborating with the Clinical Data Interchange Standards Consortium (CDISC) to develop a standardized data model and (b) working with lead collaborators and other stakeholders to develop the SDR reference implementation. The approach comprises the following:

Standards Collaboration: CDISC has developed a new protocol study definition standard called the Unified Study Definition Model (USDM), alongside controlled terminology and specifications for APIs to develop the USDM, CDISC engaged key stakeholders, including technology companies and vendors

Study Definitions Repository Reference Implementation: The study definitions repository (SDR) is a novel central component aimed at using technical and data standards to facilitate the exchange of structured study definitions across clinical systems.

The SDR reference implementation is a working model of the SDR based on the USDM. It has been deployed as open-source and is meant to be vendor agnostic.

How will TransCelerate help the research and development ecosystem prepare for DDF?

Multiple stakeholders across the R&D ecosystem will be impacted. Particular focus will be paid to sponsors, technology solution providers and the many stakeholders within each. Efforts to facilitate adoption and help stakeholders (including sponsor companies and up/downstream vendor community) prepare will run across three active categories of work: analyzing, educating, and enabling stakeholder readiness for the digital data flow execution.

How will the DDF initiative ensure long-term sustainability and outcome driven success?

As the SDR reference implementation matures and becomes more stable, governance is expected to shift from TransCelerate to a more open, multi-stakeholder model.

The entity responsible for this multi-stakeholder governance model has not yet been determined. The governance model is expected to involve additional advisory committees or members to engage stakeholders, such as additional SSOs, health authorities, technology solution providers, systems integrators, and others.

The intent is to follow open-source principles wherever possible, to provide transparency and involvement in developing source code for connecting application

How will TransCelerate support and position DDF for success?

TransCelerate is uniquely positioned to catalyze this change by sponsoring and leading the collaborative project to develop an open-source technology, vendor-agnostic solution in collaboration with technology organizations, and corresponding data standards in collaboration with Standards Setting Organizations (SSO).

CDISC Unified Study Definitions Model FAQ

What is the Unified Study Definition Model (USDM)?

The model is a unified, consistent, and comprehensive approach to structure and represent study definitions (i.e., protocol) data. Study definitions in the study definition repository (SDR) conform to the USDM data standard.

USDM includes a class diagram describing the study design elements, their attributes, and relationships between them. The USDM defines all elements needed to construct a study definition, from high-level study design elements, such as study phase, indication, objectives and endpoints, and eligibility criteria, to detailed study design elements included in the schedule of activities and assessments.

CDISC has developed the USDM.

Click here for a video describing the USDM.

Click here to access the latest version of the USDM posted on CDISC.

How do standards developed through DDF relate to other existing standards?

The idea is not to create new models, but to pull together all existing standards. DDF’s collaboration with CDISC will define success from a standards perspective.

CDISC is leading the development and maintenance of standards used by the Digital Data Flow solution. By unifying existing standards and developing new standards with input from all potential end users, we enable the accessibility, interoperability, and reusability of protocol-related study definitions data.

In addition to the development of new standards, DDF will use existing standards where they exist - controlled terminology for phase of a trial is an example.

Click here to access the latest version of the USDM posted on CDISC.

Where can I access the USDM?

CDISC developed the Unified Study Definition Model (USDM). To access details of the USDM, go to https://www.cdisc.org/ddf.

Study Definitions Repository (SDR) FAQ

What is the study definition repository (SDR)?

A study definition repository (SDR) is a novel central component aimed at facilitating the exchange of structured study definitions across upstream systems (e.g., study builder) and downstream clinical systems (e.g., electronic data capturing/EDC, clinical trial management system/CTMS) used to execute a clinical research study. It uses technical and data standards developed by CDISC.

The SDR reference implementation demonstrates the implementation of data and technical standards defined by CDISC as the first step toward digital data flow and will catalyze the broader development of an ecosystem of connecting products. The SDR reference implementation will also demonstrate the ability to flow digital study definition information between systems through API connections to systems such as study builders, EDCs, and CTMS, with the opportunity for many additional use cases to follow., While these systems will not be part of the SDR reference implementation per se, they could demonstrate the ability to send (e.g., study builders) and receive (e.g., EDC and CTMS) study definitions data.

Click here to access a video describing the SDR reference implementation.

Is the SDR reference implementation intended to be a commercial product?

No, the SDR reference implementation will not be a fully functional product. Rather, it will be used to demonstrate and test ecosystem connectivity and interoperability. The SDR reference implementation may enable others to develop innovative commercial products. By creating a reference implementation of an SDR, we hope to motivate vendors to align their products with it and thus incorporate the new data standards. This will allow sponsors to more readily adopt an SDR.

Click here to access a video describing the SDR reference implementation.

How would vendors use the SDR reference implementation?

Vendors can connect to the SDR reference implementation to test compatibility and use the code through open-source licensing. Vendors can also take advantage of the interoperability functionality by deploying their own version in a cloud-based Software as a Service (SaaS) model or by building their own compliant SDR using a technology they choose.

In addition, sponsors can create an SDR based on the SDR reference implementation for their own use, adding new functionality if desired, with the ability to contribute to further development of the SDR reference implementation.

Click here to access a video describing the SDR reference implementation.

Open Source and GitHub FAQ

How did DDF select an open-source license?

DDF will use a permissive license, specifically Apache 2.0, for DDF.

A permissive license allows users to download, copy, use, transform, improve, and distribute the licensed code, and to incorporate that code in larger applications, including proprietary software. Permissive licenses do not require the modified code or applications with which it is used or linked or into which it is embedded to be made available under the same terms; commercial license terms are permitted.

This approach encourages adoption of an open-source solution particularly by technology solution providers. When paired with strong standards and solution governance practices, along with continued awareness-building of DDF across the ecosystem, we believe this will maximize uptake of DDF.

This is a highly regulated GXP environment. Are regulators ready for open-source solutions?

Health authority regulations generally do not differentiate between open source and commercial software. From a regulatory point of view, pharma sponsors are accountable for the quality of the submissions and the required validation of computerized systems used to run clinical studies, collect and analyze data.

FDA has its own GitHub repository where they make open-source solutions available.   FDA has also sponsored the development of a clinical data collection app released under an open-source license.

How will the open source content be curated for quality and consistency over time? Will this be managed through CDISC ongoing?

We will be implementing a review process for all of the open-source contributions via Github. As the USDM data standard will be a key part of that, all contributions will need to be triaged for those that need to be routed via CDISC’s standards governance process, vs things like simple bug fixes, modifications to APIs, adaptors or extensions. Active discussions are ongoing with CDISC and leveraging their experience with their COSA initiative to align and learn more.

How do I learn more about using GitHub?

Many reference materials and documents supporting GitHub are available. Here are some links to get you started:

- Creating a GitHub Account

- GitHub Support Website

- GitHub Documentation Website

- GitHub YouTube Channel

I've submitted either an issue and/or pull request and/or discussion topic in one of the DDF repositories. When will someone respond?

As of May 2022, the DDF initiative is still the process of setting up operations, and any pull requests submitted will not be triaged at this point in time. We will update as and when we expect to start actively monitoring and responding to issues, discussions, and pull requests.

Governance on SDR reference implementation Code Updates FAQ

How can I contribute to future governance of the DDF solutions?

As the SDR reference implementation matures and becomes more stable, responsibility for governance is expected to shift from TransCelerate to a more open, multi-stakeholder model.

The entity responsible for this multi-stakeholder governance model has not yet been determined. The governance model is expected to involve additional advisory committees or members to engage stakeholders, such as additional SSOs, health authorities, technology solution providers, systems integrators, and others.

Adopting DDF FAQ

What are the biggest constraints in any organization’s adoption of DDF?

The adoption of DDF will largely depend on the current state of an organization’s readiness in ensuring that the roles impacted by DDF (study managers, study protocol authors, medical writers, data management stakeholders concerned with ensuring consistent use of standards, clinical systems (IT) stakeholders, data managers and clinicians) and primarily accountable for a study are prepared to shift to a digitized, automated data flow in the management of clinical studies.

To obtain the full benefit as envisioned by DDF, users will need to adopt a Study Builder tool compatible with the SDR solution ultimately released. Organizations interested in adopting DDF will need to evaluate their current protocol authoring processes, tools and templates. Depending on the current state at an organization, various implementation approaches can be considered, including:

- Adopting a digital protocol study builder that is or will be able to write USDM data to the SDR solution

- Developing or adapting an internal study builder/protocol authoring tool

- Creating alternate methods for producing USDM compliant data and importing the data into the SDR solution

Similarly, to connect any downstream systems consideration will need to be given to the integration approach that will used to enable receipt of the USDM structured data Depending on the architecture of the downstream systems this may involve changes to the downstream system or the creation of adapters that work directly with the SDR solutions.

In addition, individual organizations may develop other innovative implementations leveraging the SDR capabilities to exchange protocol data between systems.

Does Digital Data Flow (DDF) offer an early adopter program?

The Digital Data Flow will focus on enabling flow of study definitions data from study builders to Study Definitions Repositories (SDR) to Electronic Data Capture (EDC)/CDMS. The DDF GitHub site has been set up to foster, develop, and maintain an open-source community of active DDF project contributors. GitHub repository will be the central destination for OS material & future collaboration.

A Connectathon event will encourage demonstrations of use/connectivity to the Study Definitions Repository & CDISC standards by anyone in the vendor community. Through the GitHub and Connectathon, potential users, study builders and EDC vendors can test out the initial solution functionality and viability.

Can the DDF solution work without a study builder?

A study builder is the starting point to enable the seamless flow of study definitions data and interoperability to study definitions repository, and EDC solutions. It will be possible to import a USDM conformant JSON file directly into the SDR RI, however the JSON file would need to be constructed manually using a JSON editor or other tools. We hope to offer additional utilities to create conforming USDM JSON files in the future and encourage contributions from other groups via the DDF GitHub repository that will become publicly available.