Participant Numbers and Why They Exist

Part of Research Assistant (ASSIST) Training: Confidentiality and What You Do Not Say.

About 1 minutes. Free, in your language, no account needed.

The number is the name, outside the site

Each participant is given a study number. Outside the site, that number is how they are identified. The sponsor, the database and the laboratory receive the number, not the name.

The link between number and name stays at the site, in a document kept securely and separately. That separation is the protection: someone who obtains the study data cannot identify anyone from it.

What this means for your habits

Never write a participant's name on anything that leaves the site. Not on a sample tube, not on a form going to the sponsor, not in an email.

Check the number as carefully as you would check a name. A transposed digit does not look wrong the way a wrong name does, which is exactly why it is dangerous. It silently attaches one person's result to another person's record.

Do not put identifiers in email

Names, dates of birth, hospital numbers and addresses do not belong in ordinary email. If you need to discuss a specific participant, use the study number and the site's approved system.

If you receive an email containing identifiers, do not forward it. Tell your coordinator.

Documents that carry both

Consent forms carry the name and the number together, which is why they are handled and stored carefully and are not photocopied casually. Screening logs are similar.

If you are asked to file, scan or send one of these, check with the coordinator where it goes. These are the documents where a filing error is a confidentiality breach.