Definitions #
The list of features that a person must have to be allowed to join a clinical trial, such as age or disease type.
Technical Defined baseline characteristics—age, diagnosis, stage, prior treatment—that determine a potential subject’s eligibility for enrollment in a protocol.
Example The inclusion criteria for the Phase III study require patients aged 18–75 with histologically confirmed NSCLC.
In medical research, the specific conditions that make a patient acceptable for a study; if any criterion is missing, the patient is excluded.
Technical Operational set of pre-specified attributes in a study protocol that must be present for a subject to be randomized or treated.
Etymology #
From Latin includere (to enclose) and Greek kriterion (a standard for judging); the phrase emerged in modern clinical trial methodology.
Collocations #
- protocol inclusion criteria 研究方案中规定的入组标准
- meet inclusion criteria 符合入组条件
- stringent inclusion criteria 严格的入组标准
Real Business Examples #
- Inclusion criteria specify that participants must have an ECOG performance status of 0 or 1.
- All subjects who fulfill the inclusion criteria and provide informed consent will be screened.
Register & Variants #
- Register: formal
- BrE/AmE: 全球通用，阿美英语均使用，英式更常见于学术文体
Synonyms & Antonyms #
- Synonyms: eligibility criteria, enrollment criteria
- Antonyms: exclusion criteria
Common Errors #
- 将 inclusion criteria 误写作 including criteria 正确拼写是 inclusion criteria，意为“入组标准”而非“包括标准”
- 混淆 inclusion 与 exclusion 的边界 必须清楚区分：inclusion 是具备条件，exclusion 是排除条件，不可互相替代
Confusable Terms #
- Eligibility Criteria vs Inclusion Criteria
- Eligibility criteria 常作为 inclusion/exclusion 的总称，而 inclusion criteria 特指必须满足的条件。
Frequently Asked Questions
为什么 inclusion criteria 很重要？?
它确保研究人群的均质性，提高结果可靠性，并保护受试者安全。
如果病人不满足全部 inclusion criteria 怎么办？?
通常会被排除或产生 protocol deviation，需具体分析。
Published: 2026-09-24 Category: Clinical