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Individual

An Individual entry documents a human participant (or the source patient behind a derived model) from whom biospecimens were collected for MC2 Center-supported research. Individual metadata captures demographic information, diagnosis and staging at the individual level, and longitudinal clinical outcomes such as treatment history, recurrence, and vital status.

This model outlines the key attributes needed to describe an individual independent of any single specimen or assay, so that clinical context collected once can be linked across every biospecimen, model, and dataset derived from that individual.

Why You Should Contribute Individual Entries

Contributing individual entries ensures that clinical and demographic context is recorded once and consistently reused across every biospecimen and downstream dataset tied to that person, rather than being duplicated or left out of assay-level metadata. This supports accurate cohort analysis, reduces re-collection of the same clinical details, and helps ensure patient privacy is respected through consistent de-identified identifiers.

Sharing human-derived data responsibly

If you are planning to share human-derived data, verify that you have satisfied any institutional review policies.

Before uploading data to Synapse, be sure that the information is de-identified and anonymized. If this is not possible, you have any concerns, or are unsure if a file or type of metadata is suitable to share, ask the MC2 Center!

Who Should Be Contributing Individual Entries?

  1. Clinical Research Coordinators – Ensure demographic and diagnosis information is accurately captured at enrollment.
  2. Data Managers – Maintain the individual-level record that biospecimen and model entries key off of.
  3. Principal Investigators (PIs) – Ensure longitudinal outcomes (treatment response, recurrence, vital status) are kept up to date as a study progresses.
  4. Biobank Coordinators – Link individuals to the biospecimens collected from them.

Download Template

You can download the Individual entry template, which includes all required fields, to streamline the data entry process.

Full Field Reference

Below is the full field reference table with attributes and their descriptions.

Attribute Description Required Column Type Format Regex Pattern Standard Terms CDE Examples
Individual_id Unique row identifier, used as a primary key for record updates. This should follow the GrantNumber-INDxxx convention unless otherwise indicated. True string None ^CA\d{6}-IND\d{1,9}$ None CDE:12220014
Study Key The unique Study_id foreign keys associated with the resource, found in the grant Study information. Used to group the resource with other components. Please provide multiple values as a comma-separated list. False string None None None
Individual dbGaP Subject Id The identifer assigned to the participant by dbGap False string None None None
Sex Biological sex associated with the individual, biospecimen donor, or model. True string None None View CDE:7572817, CRDC_CDE:7572817
Individual Gender Text designations that identify gender. Gender is described as the assemblage of properties that distinguish people on the basis of their societal roles. Identification of gender is based upon self-report and may come from a form, questionnaire, interview, etc. False string None None View
Individual Age at Diagnosis Age at the time the individual was diagnosed, expressed in years. Note: the CRDC-required CDE for this concept (Subject Age At Diagnosis, CDE 10609539) expresses this value in days rather than years; a documented days<->years derivation is implemented at the mapping/ETL layer for CRDC submission, not as a separate stored field. False number None None None CDE:15019300, CRDC_CDE:10609539
Disease Type The type of tumor associated with the individual, biospecimen, or model. Multiple values permitted, comma separated. False string_list None None View CDE:13471160
Primary Diagnosis Text term used to describe the histologic diagnosis of the patient, biospecimen donor, or model (NCI Thesaurus concept name -- reference-validated, not a fixed list; see https://ncithesaurus.nci.nih.gov/). True string None None None CRDC_CDE:14905532
Primary Site The UBERON identifier of the organ or part of the body where the disease began, i.e. the primary/original disease site (see https://www.ebi.ac.uk/ols4/ontologies/uberon). Reference-validated, not a fixed list. False string None ^UBERON:\d+$ None CDE:14883047, CRDC_CDE:14883047
Individual Primary Tumor Stage Extent of the primary cancer based on evidence obtained from clinical assessment parameters determined prior to treatment. False string None None View CDE:3440328
Site of Origin The UBERON identifier of the anatomic site of origin of the patient's, biospecimen donor's, or model's malignant disease (see https://www.ebi.ac.uk/ols4/ontologies/uberon). False string None ^UBERON:\d+$ None CDE:14156279, CRDC_CDE:14883072
Tumor Subtype The molecular or histologic subtype of the tumor associated with the individual, biospecimen, or model. False string_list None None None
Tumor Grade Numeric value to express the degree of abnormality of cancer cells, a measure of differentiation and aggressiveness. False string None None View CDE:11325685, CRDC_CDE:11325685
Individual Tumor Lymph Node Stage Extent of the regional lymph node involvement for the cancer based on evidence obtained from clinical assessment parameters determined prior to treatment. False string None None View CDE:3440330
Known Metastasis Sites The UBERON identifier(s) of the anatomic site(s) of metastasis associated with the malignant disease of the individual or biospecimen donor (see https://www.ebi.ac.uk/ols4/ontologies/uberon). Provide multiple values as a comma-separated list. False string_list None ^UBERON:\d+$ None CDE:2856440, CRDC_CDE:15114457
Individual Metastasis Stage Extent of the distant metastasis for the cancer based on evidence obtained from clinical assessment parameters determined prior to treatment. False string None None View CDE:3440331
Treatment Type Text term that describes the kind of treatment administered to the individual, biospecimen donor, or model. False string_list None None View CDE:14737565, CRDC_CDE:14737565
Therapeutic Agent The name of the individual agent(s) used as part of a treatment regimen or experimental protocol (NCI Thesaurus concept name -- reference-validated, not a fixed list; see https://ncithesaurus.nci.nih.gov/). False string_list None None None CRDC_CDE:14913015
Days to Treatment Number of days between the date used for index and the date the treatment started. False number None None None
Treatment Response Text term that describes the final outcome after a treatment was administered to the individual, biospecimen donor, or model. False string None None View CDE:13383448, CRDC_CDE:13383448, CRDC_CDE:15179918
Individual Days to Last Followup Number of days between the dates used for index and last follow-up False number None None None
Individual Recurrence Status Yes/No/Unknown indicator to identify whether a patient has had a new tumor event after initial treatment. False string None None View CDE:13529783, CRDC_CDE:13529783
Individual Days To Recurrence Number of days between the date used for index and the date the patient's disease recurred False number None None None
Individual Days to Last Known Disease Status Time interval from the date of last follow up to the date of initial pathologic diagnosis, represented as a calculated number of days. False number None None None
Last Known Disease Status Text term that describes the last known disease status of the individual, biospecimen donor, or model. False string None None View CDE:12447172, CRDC_CDE:12447172
Individual Vital Status Text term that describes the patient's current vital status. False string None None View CDE:2847330, CRDC_CDE:2847330
Individual Residual Disease Status A text term describing the assessment of the presence of tumor cells remaining in the body following cancer treatment. False string None None None CRDC_CDE:15157297
Individual Age 90 or Older The response to indicate whether an individual is age 90 or older. False string None None None CRDC_CDE:15354920
Individual Year of Birth The 4-digit year of the subject's birth. False number None None None CRDC_CDE:16032218
Individual Year of Death The year of a subject's death. False number None None None CRDC_CDE:15112166
Individual Year of Diagnosis Numeric value to represent the year of an individual's diagnosis of cancer. False number None None None CRDC_CDE:15157224
Individual Disease Progression or Recurrence Type A term describing the kind of worsening or return of disease that a subject is experiencing. False string None None None CRDC_CDE:14742451
ICD-10-CM Disease Code An alphanumeric value from the tenth version of the International Classification of Disease (ICD-10-CM) used to identify the diagnosis (e.g. C80.1). Reference-validated against the ICD-10-CM code system, not a fixed list. False string None ^[A-Z][0-9]{2}(\.[0-9A-Z]{1,4})?-?$ None CRDC_CDE:11479873
Individual Lymph Node Involvement Anatomic Site Uberon Identifier The UBERON identifier of the organ or part of the body describing lymph node involvement in disease (see https://www.ebi.ac.uk/ols4/ontologies/uberon). False string None ^UBERON:\d+$ None CRDC_CDE:14883075
Individual Progression or Recurrence Anatomic Site Uberon Identifier The UBERON identifier of the organ or part of the body related to the progressive or recurrent disease (see https://www.ebi.ac.uk/ols4/ontologies/uberon). False string None ^UBERON:\d+$ None CRDC_CDE:14883061
Treatment Anatomic Site The UBERON identifier of the organ or part of the body targeted by a therapeutic procedure (see https://www.ebi.ac.uk/ols4/ontologies/uberon). False string None ^UBERON:\d+$ None CRDC_CDE:14461856
Individual Treatment Intent Type Text term to identify the reason for the administration of a treatment regimen. False string None None None CRDC_CDE:15157467
Individual Treatment or Therapy Indicator An indicator that describes whether therapy was administered. False string None None None CRDC_CDE:14713318