Base Institution - The Cancer Consortium institution employing PATS user.
Clinical Trial - A prospective study involving human research subjects designed to answer specific questions about the effects or impact of various interventions on the research subject.
Date Consent Signed - Date subject or their designee signed the consent to participate in the study. If subject is re-consented, do not record the dates of each re-consent.
Date Enrolled on Study - Enrollment is considered to be: date subject either started any type of treatment, some kind of intervention on a study, or filled out a questionnaire for a research study. This includes any blood draws or screening to determine eligibility for a study.
Disease Site - The disease sites to be tracked as defined by the NCI Standard Cancer Center Information Summary 3. See also NCI Summary 3.
- Anus - Multiple Myeloma
- Bones and Joints - Mycosis Fungoides
- Brain & Nervous System - Myeloid and Monocytic Leukemia
- Breast - Female - Non-Hodgkin Lymphoma
- Breast - Male - Other Digestive Organ
- Cervix - Other Endocrine System
- Colon - Other Female Genital
- Corpus - Other Hematopoietic
- Esophagus - Other Male Genital
- Eye and Orbit - Other Respiratory & Intrathoracic Organs
- Hodgkin Lymphoma - Other Skin
- Ill - defined Sites - Other Urinary
- Kaposis sarcoma - Ovary
- Kidney - Pancreas
- Larynx - Prostate
- Leukemia, not otherwise specified - Rectum
- Leukemia, Other - Small Intestine
- Lip, Oral Cavity and Phyarynx - Soft Tissue
- Liver - Stomach
- Lung - Thyroid
- Lymphoid Leukemia - Unknown Sites
- Melanoma, skin - Urinary Bladder
Ethnicity - Subject's ethnicity: Select "Hispanic/Latino" or "Not Hispanic or Latino". Hispanic or Latino is defined as: a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, "Spanish origin," can be used in addition to "Hispanic or Latino." See also OMB Standards for Federal Race and Ethnicity Data.
Intervention - May include drugs, procedures, devices, diet, or behavioral strategies such as exercise and counseling.
NCI Table 3 - The National Cancer Institute has determined that a fundamental set of information (referred to as the Standard Cancer Center Information summaries) should be included in all competing and noncompeting continuation Cancer Center Support Grant applications. More information regarding Table 3 can be found here (includes a table of ICD9 codes applicable to each Disease Site).
OMB standards for federal race and ethnicity data - The minimum categories established by the Office of Management and Budget (OMB) for data on race and ethnicity for Federal statistics, program administrative reporting, and civil rights compliance reporting which became effective on January 1, 2003, can be found at this link: OMB Standards for the Classification of Federal Data on Race and Ethnicity
Patient - Any person enrolled onto a treatment protocol.
Protocol Cooperative Group Number - Number assigned by the cooperative group sponsoring the study. This would only apply to national cooperative groups (e.g., SWOG, NSABP, COG), not an industry-sponsored study number.
Protocol Number - The number for the protocol assigned by the institution approving the protocol. This number is needed to link to the protocol number in the registration data base. For cooperative group, SC, FHCRC, or PSOC studies, use the protocol number assigned. For studies approved by the UW IRB, use the IRB number. Do not use institutional contract numbers or budget numbers.
Race - Subject's race: Select "American Indian or Alaska Native", "Asian", "Black or African American", "Native Hawaiian or Other Pacific Islander", or "White." See also OMB Standards for Federal Race and Ethnicity Data.
Research Subject - Any person who has signed a consent to participate in any type of IRB-approved Intervention study.
Registration - The notification of the accrual of a subject onto a study. (Please note that PATS is not a patient registration system. It is a system to enable the Consortium to report summary information to the NCI and other funding agencies.)
Subject's Unique Study Number - Unique number assigned to the patient. For FHCRC patients, this would be the subject's FHCRC assigned UPN (Universal Person Number) number. For industry-sponsored studies, this would be the subject number assigned by the sponsor. For cooperative group studies, this would be the group study number. For investigator-initiated studies, this would be the "tracking" number used to identify subjects on the study.