Demographics
Local ID:
Enter a subject identifier, up to ten characters are allowed. This ID is used by the center to identify the subject. Examples include subject initials, medical record number, etc.
Date of birth:
Report the subject’s date of birth if the DD/MMM/YYYY format, i.e. 01Oct2018.
Age:
The age is system generated in years and will be derived by RAVE. This field requires no response from the study site and cannot be edited.
Sex:
Indicate the patient’s biological sex as male or female.
Ethnicity:
Indicate the subject’s ethnicity as one of the following:
Hispanic or Latino
Hispanic or Latino refers to people whose ancestors or descendants originated in Central and South America and in the Caribbean, who follow the customs and cultures of these areas and who may speak Spanish.
The phrase Hispanic or Latino excludes people born in Europe whose language is Spanish or Portuguese, and non-Spanish speaking people born in Brazil, Belize, French Guyana, Guyana, Surinam and other non-Spanish speaking territories.
- Chicano – Includes people born in the United States with Mexican ancestry.
- Latino – This term can be used by individuals who live throughout the United States. Many Latinos have come from Puerto Rico, Dominican Republic, Cuba and/or South America.
- Mexican – Includes all citizens of Mexico regardless of race.
- Puerto Rican – Includes all persons of Puerto Rican descent.
Not Hispanic or Latino
A member of any ethnicity, other than Hispanic.
Refused/Not Reported
Indicate if the subject declines to provide this information.
Unknown
Indicate if the subject’s ethnicity is not documented
Not applicable, not a resident of the USA
Indicate if the subject is not a resident of the USA.
Race:
Indicate the subject’s race as the following (if the recipient has reported they are more than one race, check each race with which the recipient identifies):
White
Includes persons who indicate their race as White such as Canadian, German, Italian, Lebanese, Near Easterner, Arabian, Eastern European, etc.
Black or African American
Includes persons having origins in any of the Black racial groups of Africa, including Black Americans, Africans, Haitians, and residents of Caribbean Islands of African descent.
Asian
Includes persons with ancestors in any of the original peoples of the Far East, the Indian subcontinent including Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, Philippine Islands, Thailand, Vietnam, Hmong, East India, Laos, Bangladesh, Indonesia, Sri Lanka, Nepal, Bhutan, Sikh, Burma and other South and Southeast Asian.
American Indian or Alaska Native
Includes persons having origins in any of the original peoples of North, South or Central America.
Native Hawaiian or Other Pacific Islander
Native Hawaiian refers to persons having origins in any of the original peoples of the Hawaiian Islands, Guam or Samoa. Pacific Islander refers to persons having origins in any of the peoples of the Pacific Islands.
Refused / Not Reported
Indicate if the subject declines to provide this information.
Unknown
Indicate if the subject’s race is not documented.
1704 CHARM Study Informed Consent
Study ICF language:
Report language of the 1704 CHARM Informed Consent to Participate in Research Study used to obtain recipient or legal guardian consent (up to 100 characters). If a short form was used, report the language and indicate “short form.” For Example, “Spanish short form.”
Study ICF version:
Report which version of the 1704 CHARM Informed Consent to Participate in Research Study was used to obtain recipient consent (up to 100 characters). Indicate the version number and/or version date of the signed consent form.
Date study ICF signed:
Enter date the 1704 CHARM Informed Consent to Participate in Research Study was signed by the recipient in DD/MMM/YYYY format.
System generated answers (NO RESPONSE REQUIRED)
Subject ID:
A subject ID will be generated by the system after the Demographics form is first saved. The subject ID is a derived value CHARM + CCN + # in the study, i.e. CHARM12000-0001. This field requires no response from the study site and cannot be edited.
Subject status:
The subject status is system-generated. This field requires no response from the study site and cannot be edited.
CCG v.4.0 | CRF v.3.0
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