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Digital Data Flow

DDF Transformation Tools

TransCelerate has created Transformation Tools to help stakeholders manage the changes associated with adopting DDF in their organizations.

See the Sponsor Company DDF Transformation Tools information on this page. Other stakeholder tools are forthcoming.

For guidance and information on getting started with DDF, click Getting Started.

The purpose of the Sponsor Company DDF Transformation Tools is to help sponsor companies manage the changes associated with adopting DDF.

TransCelerate organized the toolkit into 4 steps to guide your company through key change management activities.

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Topic Description
Purpose Understand the stages toward adopting DDF to help create a potential roadmap toward a future state with DDF
Outcome Clear understanding of the Change Management Journey
Action Steps Click here for the Change Management Journey

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Topic Description
Purpose Identify and match organizational functional areas to DDF personas
Outcome Understand which of your organization's functional areas are impacted by adopting DDF
Action Steps Click here for the DDF Personas: Sponsor Company Edition

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Topic Description
Purpose Determine the current state of your organization on the DDF Change Management Journey
Outcome Obtain a clear understanding of where your organization aligns to on the DDF Change Management Journey
Action Steps Click here for an Organization Self-Assessment

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Topic Description
Purpose Determine your organization's future state involving DDF
Outcome Develop a high level roadmap for your organization regarding DDF
Action Steps Use the DDF Change Management Journey and Current State information to create a future state roadmap

TransCelerate has created several persona-specific toolkits to support change management and transformational activities within sponsor organizations.

Please note, job titles, roles, & responsibilities can and will vary, often significantly, across companies. The persona toolkits seek to outline some discrete tasks commonly performed by specific roles as part of that persona and explain how the DDF initiative will likely impact these tasks. The toolkits do not seek to address all tasks performed by personas nor does it seek to dictate or suggest to the persona how relevant tasks must or should be performed, as this will vary greatly across companies.

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This toolkit is a change resource for Protocol Medical Writers that describes how the DDF initiative will likely impact some discrete tasks commonly performed by this persona. Below table includes a link to the full toolkit (eBook), as well as each individual section of the toolkit so each component can be accessed separately.
Content Description
[Full Toolkit] DDF Persona Toolkit for Protocol Medical Writer (MW) The objective is to help protocol medical writers understand and better prepare for how to adapt their role and responsibilities to new ways of working within an automated and digitalized study lifecycle.
DDF Initiative Overview This overview provides key information pertaining to the overall Digital Data Flow (DDF) Initiative.
Toolkit Overview (MW) This describes the toolkit purpose, components, and ways to use it.
Persona Profile Card (MW) This articulates potential impacts to a Protocol Medical Writer’s role comparing the current state (As-Is) to the anticipated future state (To-Be).
Persona Change Impacts (MW) This articulates potential impacts to a Protocol Medical Writer’s role comparing the current state (As-Is) to the anticipated future state (To-Be).
Persona Day in the Life (MW) An illustrative flow of “What could a work-day look like with the application of DDF?”

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This toolkit is a change resource for Clinical Data Manager that describes how the DDF initiative will likely impact some discrete tasks commonly performed by this persona. Below table includes a link to the full toolkit (eBook), as well as each individual section of the toolkit so each component can be accessed separately.
Content Description
[Full Toolkit] DDF Persona Toolkit for Clinical Data Manager (DM) The objective is to help clinical data managers understand and better prepare for how to adapt their role and responsibilities to new ways of working within an automated and digitalized study lifecycle.
DDF Initiative Overview This overview provides key information pertaining to the overall Digital Data Flow (DDF) Initiative.
Toolkit Overview (DM) This describes the toolkit purpose, components, and ways to use it.
Persona Profile Card (DM) This describes the profile for a typical Clinical Data Manager role as described in this toolkit. It can be utilized to help Clinical Data Manager understand the benefits and value of digitalization of data flow within the context of protocol authoring.
Persona Change Impacts (DM) This articulates potential impacts to a Clinical Data Manager role comparing the current state (As-Is) to the anticipated future state (To-Be).
Persona Day in the Life (DM) An illustrative flow of “What could a work-day look like with the application of DDF?”

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This toolkit is a change resource for IT Leadership and IT Technical Experts that describes how the DDF initiative will likely impact some discrete tasks commonly performed by these personas. Below table includes a link to the full toolkit (eBook), as well as each individual section of the toolkit so each component can be accessed separately.
Content Description
[Full Toolkit] DDF Persona Toolkit for Information Technology (IT) The objective is to help the IT Leadership and IT Technical Expert roles understand the anticipated benefits of the DDF initiative and better prepare for how their role and responsibilities may need to adapt to new ways of working.
DDF Initiative Overview This overview provides key information pertaining to the overall Digital Data Flow (DDF) Initiative.
Toolkit Overview (IT) This describes the toolkit purpose, components, and ways to use it.
Persona Profile Card – IT Leadership This describes the profile for a typical Information Technology (IT) Leadership role as described in this toolkit. It can be utilized to help this role understand the benefits and value of digitalization of data flow across the study lifecycle from study design startup to execution.
Persona Profile Card – IT Technical Expert This describes the profile for a typical Information Technology (IT) Technical Expert role as described in this toolkit. It can be utilized to help this role understand the benefits and value of digitalization of data flow across the study lifecycle from study design startup to execution.
Building a Case for Change High-level guidance for Business and IT functions to partner on implementing DDF solutions within sponsor companies.