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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

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Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

This document is intended to provide additional information to sponsors in deciding to implement eSRA for evaluating site system’s readiness to provide regulatory-acceptable data for their clinical trials. It includes a mapping of eSRA questions to statements from regulatory authority documents.

This document is intended to be used in conjunction with the eSRA Handbook and Questionnaire.

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BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
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