Roles & Responsibilities CoLab

Site Adoption

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Roles & Responsibilities
through the Site Lens

It is often unclear to sites whose responsibility it is to do what when using DCT elements.  

Site considerations for implementation of DCT elements include:

  • Training for staff and patients
  • Ongoing technical support
  • Resource impact (Budget and staff)
  • Responsibility for key tasks across each DCT element
  • Logistics and workflows
  • Integrations
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Roles & Responsibilities: Scope

Study Set up and Execution and Close out Tasks

Roles including site staff, sponsor / CRO team, DCT tech and service providers

Trials that are built to use DCT elements

Goals:  

  • Increase clarity and expectations across stakeholders
  • Decrease ambiguity for sites implementing DCT elements
  • Ensure the appropriate resources are allocated at the site

Decision elements to determine appropriate documentation of delegated trial-related activities

Screenshot 2023-10-31 at 7.55.25 AM
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A Guide for Stakeholders with Timing

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1. Instructions

  • End Users
  • Timing
  • Assumptions
  • Recommendations
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2. Platform Level

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3. Training Expectations

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4. DCT Elements

Click the links below to access each Key Questions and Decisions document
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Patient Recruitment/Engagement

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eConsent

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Home Nursing

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Biospecimen Collection

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DTP IP Shipment

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ePRO and eCOA

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DTP Supplies

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Wearables/DHT

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Creating an Input Tool as a RACI

Key Decisions:

  • Timing:  recommendations related to when to ask about decentralized capabilities - feasibility / selection vs. Activation
  • Visual:  Create a guide by DCT element for sponsors and sites to utilize to clarify expectations before agreeing to participate
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How to Utilize these Tools

Learn how to best utilize these resources in your trial planning by reviewing the video below from the leaders of this work.

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Roles & Responsibilities Feedback