Subject identification code

A subject identification code (also participant id, subject id, study subject number, patient identification number (PIN), unique subject identifier (USI), enrollment number) is a unique identifier assigned to each participant in a clinical trial. This code is used to maintain the confidentiality of participants by replacing personally identifiable information with a code known only to the research team.

Definitions

ICH E6(R2)

1.58 Subject Identification Code:

A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data .

Assignment of subject identification numbers

In practice, the subject identification code is typically a combination of letters and numbers, and usually consists of the trial site number followed by the subject’s sequential number. This number is assigned during the enrollment or randomization procedure using computerized systems such as interactive web response systems (IWRS).

Confidentiality and privacy of subjects

The subject identification code is used in all study-related documents, databases, and reports, allowing the linking of clinical data collected during the study without revealing the participant’s identity.

The principal investigator is responsible for creating and maintaining a subject identification list that links patients’ personal information with their study number. This log is considered private and is never removed from the site (e.g., it is never collected by a monitor for the trial master file).

See also

Another relevant pages

• Subject