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Limiting Information Collected During Study Prescreening

Prescreening can guide a potential candidate toward a detailed research discussion.

Representative research photograph: Limiting Information Collected During Study Prescreening
Photo: NCI Clinical Center/Mathews Media Group · License: Public domain · Cropped and resized.
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Prescreening can guide a potential candidate toward a detailed research discussion. However, collecting unnecessary health information or behaving as though eligibility is already established creates different risks. A question set with a clear purpose can help the site preserve that boundary.

Define the workflow

Review which next step each question supports. Distinguish information a coordinator may handle from clinical matters requiring investigator interpretation. Examine the intended process, approved materials and applicable privacy arrangements rather than copying a questionnaire directly from another study.

Worked example

For example, an initial conversation requires only a few details for scheduling but asks for an extensive disease history. The team maps questions to their purpose and submits unnecessary fields for appropriate removal review. An uncertain answer prompts investigator discussion instead of a coordinator’s medical guess.

Practical checks

  • Link each question to a concrete referral or preparation decision and assess necessity.
  • Define a route to the authorized investigator for answers requiring clinical interpretation.
  • Avoid presenting a prescreening record as study acceptance or completed informed consent.

Decision and boundaries

A good process tells people why information is requested and what happens next. Avoid pressure when someone does not want to provide it. Manage access and retention through applicable arrangements. Creating an indefinite candidate file for unspecified future studies is not an automatic purpose of prescreening.

Frequently asked questions

Does prescreening establish final eligibility?
No. Do not promise acceptance before required assessments and authorized investigator review have been completed for the study.
Is a question suitable because another study used it?
Previous use alone is insufficient. Assess the new purpose, protocol, approvals and information needs before adopting it.

Sources

  1. EMA — ICH E6 Good Clinical Practice
  2. FDA — Informed consent guidance