CliniGA CRO

CliniGA CRO Blog

Communicating Unexpected Delays During Study Visits

A longer wait can affect a participant’s work, travel or caring arrangements.

Representative research photograph: Communicating Unexpected Delays During Study Visits
Photo: Tech. Sgt. Cohrs, U.S. Army · License: Public domain · Cropped and resized.
Published
Updated

A longer wait can affect a participant’s work, travel or caring arrangements. Silence about a delay may increase uncertainty and concern. By separating known information from what remains unclear, the site can provide realistic updates and an appropriate route for questions.

Define the workflow

Authorized staff assess implications for protocol activities. A coordinator can explain the current situation without guaranteeing a finishing time or promising that a procedure can be omitted. Do not disclose another participant’s health information as an explanation for why the visit is running late.

Worked example

For example, an assessment room becomes unavailable and someone’s return transport is due at a fixed time. Staff notify them early, listen to the travel constraint and review suitable options with the investigator. An unperformed activity is not recorded as complete merely to preserve the schedule; explain the revised plan clearly.

Practical checks

  • Define who updates the participant and how often once a delay becomes apparent.
  • Distinguish an estimated duration from a guaranteed finishing time in the explanation.
  • Review effects on safety, protocol activities and daily plans with the appropriate team.

Decision and boundaries

Good communication does not eliminate every delay, but prevents people being left in unexplained uncertainty. Keep offered options and decisions traceable. An apology or explanation does not replace clinical assessment. Review recurrent delays through capacity and visit design as well as individual circumstances, rather than labelling them a participant’s lack of patience.

Frequently asked questions

Should every detail of the delay be disclosed?
Provide information useful for the person’s plans while protecting others’ privacy and avoiding unnecessary internal detail.
Can a procedure be omitted if someone cannot wait?
The investigator reviews protocol and safety implications; a coordinator should not make that decision independently for convenience.

Sources

  1. EMA — ICH E6 Good Clinical Practice
  2. WHO — Guidance for best practices for clinical trials