Table 1 INCLUDE under-served groups mapped to items reviewed in the audit

Demographic factors

Age extremes (e.g., under 18 and over 75)

Minimum/

maximum age

N/A

Date of birth

Date of birth

Women of childbearing age

Pregnancy status/ age/ sex

N/A

Date of birth / sex

N/A

Black, Asian and Ethnic Minorities

Ethnic group

N/A

Ethnic group

Ethnic group

Male/female sex (depending on trial context)

Sex/gender

Use of gendered words

Sex/gender

Sex/gender

LGBTQ + /sexual orientation

Sexual orientation

Use of gendered words

Sexual orientation

Sexual orientation

Educational disadvantage

N/A

Readability scores and word counts, availability in non-written format

Highest education level

Highest education level

Social and economic factors

In full time employment

N/A

N/A

Employment status

Employment status collection

Unemployed/ low income^ab

N/A

N/A

Employment status/ income

Employment status/ income

Military veterans

N/A

N/A

Military veteran status

Military veteran status

People in alternative residential circumstances (migrants, asylum seekers, prison populations, care homes, traveller communities and homeless)^ab

N/A

N/A

Residence details

Residence details

People living in remote areas^a

Geographical area/access to hospital

N/A

Residence details/ postcode

Residence details/ postcode

Religious minorities

N/A

N/A

Religion

Religion

Carers^a

N/A

N/A

N/A

Carer status

People not fluent in the majority language

Fluent in English

Availability of patient information in alternative languages

Main language

Main language, availability in alternative languages

People who do not attend regular medical appointments

Not possible to identify from trial documents

People in multiple excluded categories

Not possible to identify from trial documents

Socially marginalised people^a

Not possible to identify directly – possible other groups in this category indicated with ^a

Stigmatised populations^b

Not possible to identify directly – possible other groups in this category indicated with ^b

Looked after children

Not relevant to ICR-CTSU trials – all conducted in adult population

Health status

Mental health conditions^ab

Mental health condition exclusions

N/A

N/A

N/A

People who lack the capacity to consent for themselves^ab

Not relevant to ICR-CTSU trials – all require capacity to consent

Cognitive impairment^ab

Brain metastasis

N/A

N/A

N/A

Learning disability^ab

Learning disability

Availability in different formats

N/A

N/A

People with addictions^ab

Substance addiction

N/A

Medical history collection

Medical history collection

Pregnant women

Pregnancy status

N/A

N/A

N/A

People with multiple health conditions^a

HIV status / prior malignancies

N/A

Baseline symptoms/ medical history

collection

Baseline symptoms/ medical history collection

Physical disabilities^a

Physical accessibilty requirements /performance status

N/A

Baseline symptoms/ medical history

collection

Baseline symptoms/ medical history

collection

Visually/ hearing impaired^a

N/A

Availability of documents in different formats

N/A

N/A

Too severely ill

Performance status

N/A

Baseline symptoms/ medical history/ performance status collection

Baseline symptoms/ medical history/ performance status collection

Smokers^b

N/A

N/A

Smoking status collection

Smoking status collection

People living with obesity^b

N/A

N/A

Weight collection

Weight collection

Rare diseases and genetic disease sub-types

N/A

N/A

Medical history collection

Medical history collection

People in cancer trials with brain metastases

Brain metastasis status

N/A

Medical history collection

Medical history collection