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Testing a Participant Study Contact Card

A contact card can list many numbers while leaving someone unsure which one to call.

Representative research photograph: Testing a Participant Study Contact Card
Photo: Rhoda Baer (Photographer) · License: Public domain · Cropped and resized.
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A contact card can list many numbers while leaving someone unsure which one to call. Judge usefulness by whether it directs a real question to the appropriate route, rather than by the number of contacts printed. Keep clinical and technical responsibility boundaries clear when making the wording concise.

Define the workflow

The site can separate appointments, device support, research concerns and the appropriate urgent clinical pathway through the study arrangements. Explain availability and any suitable alternative for each channel. Do not present the card as replacing required consent materials or individual clinical instructions.

Worked example

For example, asked whom to call when a device fails, a participant finds only the investigator’s private number. Staff make the actual support arrangement clearer and test it again through realistic examples. Remove obsolete numbers and reduce confusion with earlier versions when distributing an updated copy.

Practical checks

  • Test the card with realistic scheduling, technical support and research concern scenarios.
  • Confirm numbers, availability and responsibilities with their authorized owners.
  • Check that the individual can identify the suitable route and revise ambiguous wording.

Decision and boundaries

A good card makes help easier to find and creates realistic expectations. Do not guarantee every subject will be answered at every hour. Authorized clinical staff explain necessary safety routes; a technical line should not be presented as emergency healthcare. Consider accessible text, language and storage with the person, and avoid printing unnecessary personal health details on the card.

Frequently asked questions

Do more numbers make a better card?
No. If roles and reasons for calling remain unclear, extra numbers can increase confusion instead of reducing it.
Should the card contain all study information?
Its purpose is to identify contact routes. Provide necessary detailed materials and clinical explanations through the appropriate separate processes.

Sources

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