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Explaining Coordinator Changes to Study Participants

When research staff change, a participant may continue calling an old number or doubt the identity of a new contact.

Representative research photograph: Explaining Coordinator Changes to Study Participants
Photo: Unknown photographer · License: Public domain · Cropped and resized.
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When research staff change, a participant may continue calling an old number or doubt the identity of a new contact. Clear communication handover helps people know where to direct questions. It involves more than updating an internal allocation list that participants never see.

Define the workflow

Explain the new contact and when the change takes effect through an appropriate channel. Keep routes for clinical and urgent questions distinct. Do not transfer research conversations held in personal phone accounts without control; preserve authorized records and confidentiality arrangements during the change.

Worked example

For example, someone ignores a message from an unfamiliar new coordinator. The change is confirmed through a previously known site channel, and current details are shared. An outstanding scheduling question is linked appropriately to the new owner so the person does not needlessly repeat their entire account.

Practical checks

  • Introduce the new contact through a known site channel the participant can verify.
  • Link open questions and appointment arrangements to the new owner in appropriate records.
  • Address continued use of the old number or account through the authorized process.

Decision and boundaries

A good handover explains who is responsible and what they can answer. A coordinator change should not be presented as transferring the investigator’s clinical responsibility. Preserve communication preferences and avoid broadly distributing sensitive information. Establish realistic handling for important reports that still reach the former contact after the handover.

Frequently asked questions

Should new staff receive every private conversation?
Assess information necessary for the role and authorized record scope rather than transferring personal accounts without control.
How can participants verify the new person?
Provide confirmation through a previously known appropriate site channel instead of expecting trust based solely on an unfamiliar message.

Sources

  1. EMA — ICH E6 Good Clinical Practice
  2. FDA — Conducting clinical trials with decentralized elements