Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual/Aromantic and all sexually and gender diverse (LGBTQIA+) people are at a greater risk for mental health, cardiovascular, infectious, cancer, and other chronic illnesses due to historical discrimination and marginalization. Additionally, this community has historically been excluded from clinical research studies. As a result, there is a lack of the necessary information to study the effects of health treatments and interventions for the LGBTQIA+ population. The SOGI CRF aims to promote health equity by capturing this missing information.
- The Sexual Orientation and Gender Identity (SOGI) CRF is optional.
- Participants are able to opt-out of the form by simply answering, “No” to the first question, or by answering questions as “Unknown” or “Not reported.”
- Date of Collection: Since this form may not be tied to a specific visit, this variable (SCDTC) is optional.
- The form can be used by participants (i.e., subject-facing) during a visit with an ePRO device or any electronic data capture method.
- The SOGI CRF provides additional demographic data for the Subject Characteristics (SC) domain and serves as an extension of the data collected using the Demographics (DM) domain.
- New codelists have been created to capture Sex Assigned at Birth, Gender Identity, and Sexual Orientation.
- The codelists and associated definitions are included in CDISC Controlled Terminology Package 58.
- The SOGI team used the Fenway Health glossary to assist in the semantic development.
- The Sex at Birth variable is different from the CDASH SEX variable.
- Sex at Birth is as it was recorded on the participant's birth certificate by a medical professional (i.e. Sex Assigned at Birth).
- This variable is not intended to be used with lab data (i.e., normal ranges).