Site Input to Protocol Planning CoLab

The How-To Guide for Site Input

This page links to three tools designed for sponsors to get site input to enable early, practical decisions about utilizing decentralized methods:

• Playbook: A streamlined process for collecting and using site input.
• Question Bank: Focused questions aligned with key decision points.
• Standard DCT Icons: A visual language to clarify who does what, when.

Why this matters:

DCT elements often reach sites after the protocol is locked—too late to adjust schedules, workflows, or support. That’s when burden increases and adoption drops.

This CoLab provides a simple, repeatable process to gather site input early enough to influence protocol decisions without slowing development timelines.

Who created this?

DTRA chartered a team to develop a collaborative framework in partnership with:

• Transcelerate Biopharma
• Association of Clinical Research Professionals (ACRP)
• Society for Clinical Research Sites (SCRS)

Additional contributions were provided by global sponsors, CROs, clinical research sites, and technology partners.

Co-Created with Sites

The CoLab teams led the core design and analysis, using SCRS Global Summit sessions as structured reality-checks:

• 2023: Prioritized the core problem statement with sites.
• 2024: Tested early concepts to confirm what sites need to execute DCT elements reliably
• 2025: Validated and refined this CoLab's specific outputs with a broader set of sites and geographies.

These workshops sharpened the tools but the majority of the content was build by the initaitive teams.