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Clarifying Which Documents to Bring to a Study Visit

Telling participants to bring “all your documents” can create unnecessary carrying and disclose excessive personal information.

Representative research photograph: Clarifying Which Documents to Bring to a Study Visit
Photo: U.S. Navy photo by Petty Officer 2nd Class Jonas Womack · License: Public domain · Cropped and resized.
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Telling participants to bring “all your documents” can create unnecessary carrying and disclose excessive personal information. A short purpose-based list can reduce preparation burden. The authorized team should clarify which information is actually needed for the planned assessment before the list is sent.

Define the workflow

Explain why a document is requested and whether an original or copy is needed. Consider a suitable alternative when a record is difficult to bring. Staff should not present sending an entire health file to a personal account, private messenger or uncontrolled email address as a convenient substitute.

Worked example

For example, someone arrives with years of records when the planned discussion needs a particular report. Staff review the list with the content owner. They assess need before reviewing and copying unnecessary documents, then explain a clear next step for any required report that is missing.

Practical checks

  • Link each requested document to a specific visit purpose and authorized review need.
  • Clearly distinguish an original, a copy and an appropriate secure access option.
  • Explain what a missing document affects and who determines the appropriate next step.

Decision and boundaries

A good list supports preparation while reducing unnecessary information collection. Bringing a document does not authorize unrestricted copying or reuse. The investigator assesses clinical and protocol requirements; a coordinator should not independently create an acceptance or rejection decision merely because a document is missing.

Frequently asked questions

Is the complete health record needed at every visit?
Do not assume so. Define scope according to the relevant visit purpose and authorized assessment needs.
Does forgetting a document automatically cancel participation?
Assess the information and activity affected, then determine a suitable next step with the authorized research team.

Sources

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