For human clinical trials, there is a growing movement to replace the term "study subject" with a terminology that is more respectful and recognizes the agency of those who consent to be treated and have their data collected. The term "participant”, rather than "study subject", is now used in ICH E6 R3 guidelines. The TransCelerate Biopharma Common Protocol Template states that "participant" may be used in patient-facing documents. This had led to questions about whether terms such as the following in the CDISC Standards should be changed:
Variable names (labels):
- USUBJD (Unique Subject Identifier)
- SUBJID (Subject Identifier for the Participation)
SDTMIG Domain Names:
- Subject Elements
- Subject Visits
- Subject Disease Milestones
- Subject Characteristics
- Subject Status
There are several reasons why CDISC does not plan to change these variable and domain names.
The SDTM is Used for Studies Other Than Human Clinical Trials
The SDTM is used for non-clinical trials, in which the subjects are animals. Animals have no agency in these trials, and the word "participant" is inappropriate.
The SDTM can also be used for data about humans where "participant" does not fit, such as observation studies that use historical data, and real-world data.
Variable and Domain Names Are Metadata
Displays of data and summaries of data intended for audiences sensitive to the term "subject" can use other terminology.
Changing Metadata Would Be Disruptive and Expensive
These metadata are embedded in systems and programs in many stakeholders' implementations of the standards. Changing the labels used in displays, as needed, will be much less disruptive than changing the metadata.
The Term "Participant" May Change in Future
A definition of "participant" is "a person who takes part in something”.
A definition of "subject" is "a person or thing that is being discussed, described, or dealt with".
"Participant" recognizes that in a human clinical trial a person formerly referred to as a "study subject" is a person with agency. However, it does not distinguish human study subjects from study personnel. Over time, a better, more specific and descriptive term than "participant" may be identified.