Version 0.1 DRAFT
This page provides information about CTRP trial attributes, including the data elements exposed to the NCI Clinical Trials API. This dictionary reflects information from version 1.0 of the API and version 4.4 of CTRP.
The following table displays the first seven columns from CTRP-dictionary_508compliant.xlsx. (To download the spreadsheet, click the link and follow your browser's prompts.) For a description of each column on this page and in the spreadsheet, refer to About the CTRP Dictionary.
Element ID |
Data Element |
Definition |
API |
TSR |
DW |
DB |
|---|---|---|---|---|---|---|
EID 01.01 |
record_verification_date |
Date the protocol information was last verified. Verification date is shown along with organization name on ClinicalTrials.gov to indicate to the public whether the information is being kept current, particularly recruiting status and contact information. Update verification date when reviewing the record for accuracy and completeness, even if no other changes are made. In CTRP, the Last Verified date is the most recent date on which the CTRO confirmed all of a clinical study's information in CTRP as accurate and current. |
Yes |
Yes |
Yes |
Yes |
EID 02.01 |
nci_id |
The unique ID assigned to the trial by CTRP. Format: NCI followed by YYYY followed by 5 digits <NCI-YYYY-00000>. |
Yes |
Yes |
Yes |
Yes |
EID 02.02 |
nct_id |
The unique ID assigned to the trial by PRS (ClinicalTrials.gov). Format: NCT followed by 8 numeric characters <NCT00000000>. |
Yes |
Yes |
Yes |
Yes |
EID 02.03 |
protocol_id |
The unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number. |
Yes |
Yes |
Yes |
Yes |
EID 02.04 |
ccr_id |
The unique ID assigned to the trial managed by CCR (Center for Cancer Research). |
Yes |
Yes |
Yes |
Yes |
EID 02.05 |
ctep_id |
The unique ID assigned to the trial submitted by CTEP (Cancer Therapy Evaluation Program). |
Yes |
Yes |
Yes |
Yes |
EID 02.06 |
dcp_id |
The unique ID assigned to the trial submitted by DCP (Division of Cancer Prevention). |
Yes |
Yes |
Yes |
Yes |
EID 02.07 |
other_ids |
Additional IDs assigned to the trial, including unique IDs from other registries, NIH grant numbers, or protocol numbers assigned by the review board. |
Yes |
Yes |
Yes |
Yes |
EID 02.08 |
name (component of other_ids) |
Name of the other ID. |
Yes |
No |
Yes |
Yes |
EID 02.09 |
value |
Value of the other ID. |
Yes |
Yes |
Yes |
Yes |
EID 02.10 |
amendment_date |
Date on which the trial record was last amended. The amendment date is generally entered by the trial submitter. |
Yes |
Yes |
Yes |
Yes |
EID 02.11 |
study_protocol_type |
The primary investigative techniques used in the protocol. The non-interventional value includes observational and ancillary/correlative studies. |
Yes |
Yes |
Yes |
Yes |
EID 02.12 |
study_subtype_code |
Subtype of non-interventional trials. |
Yes |
Yes |
Yes |
Yes |
EID 02.13 |
category |
Category of the trial, as determined by the submission of a full protocol (Complete) or a ClinicalTrials.gov import (Abbreviated). |
No |
Yes |
Yes |
Yes |
EID 02.14 |
amendment_number_text |
The Amendment Number is a number assigned to the trial submission as specified in the protocol document. |
No |
Yes |
Yes |
Yes |
EID 03.01 |
associated_studies |
Associated trials, as listed in the API. |
Yes |
Yes |
Yes |
Yes |
EID 03.02 |
study_id |
The ID of an associated trial. |
Yes |
Yes |
TBD |
Yes |
EID 03.03 |
study_id_type |
The type of associated trial. |
Yes |
Yes |
Yes |
Yes |
EID 03.04 |
study_a |
Associated trial, as listed in the data warehouse. |
No |
Yes |
Yes |
Yes |
EID 03.05 |
study_b |
Associated trial, as listed in the data warehouse. |
No |
Yes |
Yes |
Yes |
EID 04.01 |
brief_title |
Protocol title intended for the lay public. A title that summarizes the purpose of the trial. |
Yes |
Yes |
Yes |
Yes |
EID 04.02 |
official_title |
The official name of the protocol provided by the study principal investigator or sponsor. |
Yes |
Yes |
Yes |
Yes |
EID 04.03 |
acronym |
The abbreviation (initial letters) by which the trial is known. The acronym or initials used to identify a clinical study. |
Yes |
Yes |
Yes |
Yes |
EID 04.04 |
keywords |
Words or phrases that describe the protocol. A keyword or series of keywords that can help to classify the trial and can help users find studies in the database. |
Yes |
Yes |
Yes |
Yes |
EID 04.05 |
brief_summary |
Short description of the protocol intended for the lay public. Includes a brief statement of the study hypothesis. |
Yes |
Yes |
Yes |
Yes |
EID 04.06 |
detail_description |
Extended description of the protocol, including more technical information than the Brief Summary. May include objectives and outline. |
Yes |
Yes |
Yes |
Yes |
EID 04.07 |
principal_investigator |
Primary medical researcher in charge of carrying out a clinical trial's protocol. Appointed investigator responsible for conducting the clinical trial, or, for multi-site trials, the study chair. The PI assumes full responsibility for the treatment and evaluation of human subjects, and for the integrity of the research data and results. |
Yes |
Yes |
Yes |
TBD |
EID 04.08 |
central_contact |
Person providing centralized, coordinated recruitment information for the entire study. The central contact for the trial may be a specific person, or it may be a generic title or role. |
Yes |
Yes |
Yes |
Yes |
EID 04.09 |
central_contact_email |
The main email address of the central contact person. |
Yes |
Yes |
Yes |
Yes |
EID 04.10 |
central_contact_name |
The name of the central contact person. |
Yes |
Yes |
Yes |
Yes |
EID 04.11 |
central_contact_phone |
The main (toll free) phone number of the central contact person. |
Yes |
Yes |
Yes |
Yes |
EID 04.12 |
central_contact_type |
The contact type. |
Yes |
No |
Yes |
TBD |
EID 04.13 |
lead_org |
The coordinating/lead center of the trial, responsible for the trial's research protocol. Organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of the trial. |
Yes |
Yes |
Yes |
TBD |
EID 04.14 |
reporting_method_data_code |
Specifies how accruals are submitted to CTRP. Methods used for the principal investigator summary report, as follows: |
No |
Yes |
Yes |
Yes |
EID 04.15 |
sponsor |
Name of primary organization that oversees implementation of study and is responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3. |
No |
Yes |
Yes |
TBD |
EID 04.16 |
resp_party_type |
The party who is responsible for submitting information about a clinical study and updating that information, as defined by FDAAA. The responsible party can be the sponsor, sponsor-investigator, or sponsor-designated principal investigator. |
No |
Yes |
Yes |
Yes |
EID 04.17 |
detail_description_primary |
Primary protocol objectives concisely describe what the proposed research or activity intends to accomplish. |
No |
Yes |
Yes |
Yes |
EID 04.18 |
detail_description_secondary |
Secondary protocol objectives concisely describe what the proposed research or activity may accomplish. |
No |
Yes |
Yes |
Yes |
EID 04.19 |
detail_description_tertiary |
Protocol outline describes the interventions and procedures administered during the study. |
No |
Yes |
Yes |
Yes |
EID 05.01 |
current_trial_status |
The current stage or state of a clinical trial or study relative to other stages and its ability to enroll participants / patients. Overall accrual activity for the protocol. |
Yes |
Yes |
Yes |
Yes |
EID 05.02 |
current_trial_status_date |
The date on which the current trial status became effective. |
Yes |
Yes |
Yes |
Yes |
EID 05.03 |
start_date |
The date on which the enrollment of participants for a clinical study began (or will begin). |
Yes |
Yes |
Yes |
Yes |
EID 05.04 |
start_date_type_code |
The type of start date. |
Yes |
Yes |
Yes |
Yes |
EID 05.05 |
completion_date |
Final date on which data was (or will be) collected. |
Yes |
Yes |
Yes |
Yes |
EID 05.06 |
completion_date_type_code |
The type of completion date. |
Yes |
Yes |
Yes |
Yes |
EID 05.07 |
why_study_stopped |
A comment required only for trials at Administratively Complete, Withdrawn, or Temporarily Closed statuses. A brief explanation of why the study has been halted or terminated. For more information, check the trial's Brief Summary or Detailed Description. |
No |
Yes |
Yes |
Yes |
EID 05.08 |
primary_completion_date |
As specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial, the date that the final subject was (or will be) examined or received (or will receive) an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. |
No |
Yes |
Yes |
Yes |
EID 05.09 |
primary_completion_date_type_code |
The type of primary completion date. |
No |
Yes |
Yes |
Yes |
EID 06.01 |
oversight_authority_country |
(Retired: Deprecated by FDAAA Final Rule April 2017) |
No |
(Retired) |
(Retired) |
(Retired) |
EID 06.02 |
oversight_authority_organization_name |
(Retired: Deprecated by FDAAA Final Rule April 2017) |
No |
(Retired) |
(Retired) |
(Retired) |
EID 06.03 |
fdaregulated_indicator |
Indicates whether this trial includes an intervention subject to US FDA regulation under section 351 of the Public Health Service Act or any of the following sections of the Federal Food, Drug and Cosmetic Act: 505, 510(k), 515, 520(m), and 522. |
No |
Yes |
Yes |
Yes |
EID 06.04 |
section_801_indicator |
If this trial includes an FDA regulated intervention, then this element becomes relevant. Indicates whether this is an 'applicable clinical trial' as defined in US Public Law 110-85, which was enacted on September 27, 2007. Section 801 of US Public Law 110-85 amends Section 402 of the US Public Health Service Act to expand the clinical study registry known as ClinicalTrials.gov and create a clinical study results database. Briefly, applicable drug trials include controlled clinical investigations, other than Phase I investigations, of a drug or biologic subject to US FDA regulation. Applicable device clinical trials are controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric postmarket surveillance. |
No |
Yes |
Yes |
Yes |
EID 06.05 |
delayed_posting_indicator |
Unapproved/Uncleared Device: If this is a Section 801 applicable clinical trial, then this element becomes relevant. Indicates whether this trial includes a device not previously approved or cleared by the US FDA for any use as specified in the US Public Law 110-85, Title VIII, Section 801. |
No |
Yes |
Yes |
Yes |
EID 06.06 |
data_monitoring_committee_appointed_indicator |
Indicates whether a data monitoring committee has been appointed for this study. The data monitoring committee is group of independent scientists appointed to monitor the safety and scientific integrity of a human research intervention. The group can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also known as a data safety and monitoring board (DSMB). |
No |
Yes |
Yes |
Yes |
EID 06.07 |
fda_regulated_drug |
Indicates whether the trial studies one or more U.S. FDA-regulated drug or biologic products (a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to section 351 of the Public Health Service Act). |
TBD |
Yes |
Yes |
Yes |
EID 06.08 |
fda_regulated_device |
Indicates whether the trial studies one or more U.S. FDA-regulated device products (a device subject to section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act). |
TBD |
Yes |
Yes |
Yes |
EID 06.09 |
post_prior_to_approval |
Indicates whether the responsible party authorizes posting of the study record on ClinicalTrials.gov prior to U.S. FDA approval/clearance of device product. |
TBD |
Yes |
Yes |
Yes |
EID 06.10 |
ped_postmarket_surv |
Indicates whether the U.S. FDA has ordered a pediatric post-market surveillance of the device product. |
TBD |
Yes |
Yes |
Yes |
EID 06.11 |
exported_from_us |
Indicates whether the product is manufactured in the U.S. or one of its territories and exported for study in a clinical trial in another country. |
TBD |
Yes |
Yes |
Yes |
EID 07.01 |
irb_approval_status |
Approval status as specified by the human subjects review board. |
No |
Yes |
Yes |
Yes |
EID 07.02 |
irb_approval_number |
Number assigned by the human subjects review board upon approval of the protocol. The value may be a number or the date of approval in mm/dd/yyyy format. |
No |
Yes |
Yes |
Yes |
EID 07.03 |
irb_name |
Full name of the approving human subjects review board. |
No |
Yes |
Yes |
TBD |
EID 07.04 |
irb_organization_affiliation |
Official name of organizational affiliation of the approving human subjects review board. |
No |
Yes |
Yes |
TBD |
EID 08.01 |
ind_ide_type_code |
Specifies that the trial involves an IND or an IDE under US FDA regulations. IND indicates the trial involves an Investigational New Drug Application. IDE indicates the trial involves an Investigational Device Exemption. |
No |
Yes |
Yes |
Yes |
EID 08.02 |
grantor_code |
US FDA center to which the IND or IDE was submitted. Valid values for IND are Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER). Valid values for IDE are Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER). |
No |
Yes |
Yes |
Yes |
EID 08.03 |
ind_ide_number |
Number assigned to an IND or IDE. |
No |
Yes |
Yes |
Yes |
EID 08.04 |
holder_type_code |
The type of IND/IDE holder. |
No |
Yes |
Yes |
Yes |
EID 08.05 |
expanded_access_indicator |
Availability of Expanded Access: Indicate whether any non-protocol access is to be provided for the investigational drug or device. |
No |
Yes |
Yes |
Yes |
EID 08.06 |
expanded_access_status_code |
The status of the drug or device access when the drug or device is available outside any clinical trial protocol. |
No |
(Retired) |
Yes |
Yes |
EID 08.07 |
exempt_indicator |
(Retired: Deprecated by FDAAA Final Rule April 2017) |
No |
(Retired) |
(Retired) |
(Retired) |
EID 08.08 |
funding_mechanism_code |
A unique ID, a three-character code used to identify areas of extramural research activity applied to funding mechanisms. |
No |
Yes |
Yes |
Yes |
EID 08.09 |
nih_institution_code |
A two-letter code identifying the first major-level subdivision, the organization that supports an NIH grant, contract, or inter-agency agreement. The support may be financial or administrative. |
No |
Yes |
Yes |
Yes |
EID 08.10 |
serial_number |
The number assigned sequentially to a series within an Institute, Center, or Division. |
No |
Yes |
Yes |
Yes |
EID 08.11 |
nci_division_or_program |
The NCI organizational unit that provides funding for the study. |
No |
Yes |
Yes |
Yes |
EID 08.12 |
expanded_access_record |
Specifies the ClinicalTrials.gov identifier (NCT ID) for the associated Expanded Access record. |
TBD |
Yes |
Yes |
Yes |
EID 09.01 |
anatomic_sites |
A comma-delimited list of the anatomic site(s) on which the trial or study is focused. |
Yes |
Yes |
Yes |
Yes |
EID 09.02 |
summary_4_funding_category |
The type of Data Table 4 funding sponsorship. |
No |
Yes |
Yes |
Yes |
EID 09.03 |
specific_funding_source |
Sponsor or source of the funding mechanism. |
No |
Yes |
Yes |
TBD |
EID 09.04 |
program_code |
The alphanumeric code that identifies the clinical research program. |
No |
Yes |
Yes |
Yes |
EID 10.01 |
collaborators |
A collaborator is an organization other than the sponsor that provides support for a clinical study. This support may include funding, design, implementation, data analysis, or reporting. |
Yes |
Yes |
Yes |
Yes |
EID 10.02 |
functional_role |
The type of organization that provides support. |
Yes |
Yes |
Yes |
TBD |
EID 10.03 |
name (component of collaborators) |
Name of the collaborator organization. |
Yes |
Yes |
Yes |
TBD |
EID 11.01 |
diseases |
Disease or condition. Diseases are neoplastic or nonneoplastic conditions, disorders, syndromes, illnesses, or injuries. Conditions include any health issue that is the subject of a clinical protocol. |
Yes |
Yes |
Yes |
Yes |
EID 11.02 |
disease_code |
Unique ID assigned to the disease or condition. |
Yes |
No |
Yes |
Yes |
EID 11.03 |
inclusion_indicator (component of diseases) |
Indicates whether the system includes the disease/condition. |
Yes |
No |
Yes |
TBD |
EID 11.04 |
lead_disease_indicator |
(Not implemented.) |
Yes |
No |
Yes |
Yes |
EID 11.05 |
nci_thesaurus_concept_id (component of diseases) |
A concept unique ID within the NCI Enterprise Vocabulary Service's (EVS) NCI Thesaurus (NCIt). |
Yes |
No |
Yes |
TBD |
EID 11.06 |
preferred_name |
Standard name. Word or phrase that the NCIt uses by preference to refer to the disease or condition. |
Yes |
Yes |
Yes |
TBD |
EID 11.07 |
display_name |
The name that is used in the “reported” diseases domain. Some diseases are reported and therefore are included in the reported disease hierarchy. Others are too specific to report and are not included in the reported disease domain. The name of a reported disease in the domain can differ from the preferred name. |
Yes |
No |
Yes |
TBD |
EID 11.08 |
parents |
A comma-delimited list of concepts in the hierarchy above the disease/condition concept. Also known as super-concepts. |
Yes |
No |
Yes |
Yes |
EID 11.09 |
synonyms (component of diseases) |
A comma-delimited list of alternative names for the preferred name of the disease or condition. |
Yes |
No |
TBD |
TBD |
EID 12.01 |
classification_code |
(Retired: Deprecated by FDAAA Final Rule April 2017) |
Yes |
(Retired) |
(Retired) |
(Retired) |
EID 12.02 |
interventional_model |
Interventional Study Model: The general design of the strategy for assigning interventions to participants in a clinical study. |
Yes |
Yes |
Yes |
Yes |
EID 12.03 |
study_model_code |
The study model is the primary strategy for subject identification and follow-up. Applies to non-interventional trials. |
Yes |
Yes |
Yes |
Yes |
EID 12.04 |
study_model_other_text |
A detailed description of the trial’s study model, if the study model code is Other. |
Yes |
Yes |
Yes |
Yes |
EID 12.05 |
bio_specimen |
For Ancillary-Correlative trials that indicate that biospecimens will be retained. |
Yes |
Yes |
Yes |
Yes |
EID 12.06 |
bio_specimen_description |
All types of biospecimens to be retained (such as whole blood, serum, white cells, urine, or tissue). |
Yes |
Yes |
Yes |
Yes |
EID 12.07 |
bio_specimen_retention_code |
The DNA retention indicator. Applies to Ancillary-Correlative trials that indicate biospecimens will be retained. |
Yes |
Yes |
Yes |
Yes |
EID 12.08 |
f1 |
A bio_specimen element. |
Yes |
No |
TBD |
TBD |
EID 12.09 |
f2 |
A bio_specimen element. |
Yes |
No |
TBD |
TBD |
EID 12.10 |
f3 |
A bio_specimen element. |
Yes |
No |
TBD |
TBD |
EID 12.11 |
f4 |
A bio_specimen element. |
Yes |
No |
TBD |
TBD |
EID 12.12 |
primary_purpose |
The reason for the protocol. |
Yes |
Yes |
Yes |
Yes |
EID 12.13 |
primary_purpose_code |
The reason for the protocol. |
Yes |
Yes |
Yes |
Yes |
EID 12.14 |
primary_purpose_other_text |
A description of the trial’s primary purpose, if the primary purpose code is Other. |
Yes |
Yes |
Yes |
Yes |
EID 12.15 |
primary_purpose_additional_qualifier_code |
Additional qualifier code for the trial's primary purpose. |
Yes |
No |
Yes |
Yes |
EID 12.16 |
phase |
Phase of investigation, as defined by the US FDA for trials involving investigational new drugs. |
Yes |
Yes |
Yes |
Yes |
EID 12.17 |
phase (component of phase) |
Phase of investigation, as defined by the US FDA for trials involving investigational new drugs. |
Yes |
Yes |
Yes |
Yes |
EID 12.18 |
phase_other_text |
Other text for the trial phase. |
Yes |
No |
Yes |
Yes |
EID 12.19 |
phase_additional_qualifier_code |
This element indicates whether the trial is a pilot. |
Yes |
Yes |
Yes |
Yes |
EID 12.20 |
masking |
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. |
Yes |
Yes |
Yes |
Yes |
EID 12.21 |
masking (component of masking) |
(Retired: Deprecated by FDAAA Final Rule April 2017) |
Yes |
(Retired) |
(Retired) |
(Retired) |
EID 12.22 |
masking_allocation_code |
The clinical trial design strategy used to assign participants to an arm of a study. |
Yes |
Yes |
Yes |
Yes |
EID 12.23 |
masking_role_investigator |
This element indicates that the investigator is blind to the intervention assignments. |
Yes |
Yes |
Yes |
Yes |
EID 12.24 |
masking_role_outcome_assessor |
This element indicates that the outcome assessor is blind to the intervention assignments. |
Yes |
Yes |
Yes |
Yes |
EID 12.25 |
masking_role_subject |
This element indicates that the subject is blind to the intervention assignments. |
Yes |
Yes |
Yes |
Yes |
EID 12.26 |
masking_role_caregiver |
This element indicates that the caregiver is blind to the intervention assignments. |
Yes |
Yes |
Yes |
Yes |
EID 12.27 |
minimum_target_accrual_number |
The anticipated (target) number of subjects in the trial. |
Yes |
Yes |
Yes |
Yes |
EID 12.28 |
number_of_arms |
Number of intervention groups in the trial. |
Yes |
Yes |
Yes |
Yes |
EID 12.29 |
secondary_purpose_name |
Optional secondary reason for conducting the trial. |
No |
Yes |
Yes |
Yes |
EID 12.30 |
secondary_purpose_other_text |
A description of the trial’s secondary purpose, if the secondary purpose code is Other. |
No |
Yes |
Yes |
Yes |
EID 12.31 |
time_perspective_code |
The temporal relationship of observation period to time of subject enrollment. Applies to non-interventional trials. |
No |
Yes |
Yes |
Yes |
EID 12.32 |
time_perspective_other_text |
A description of the trial's time perspective, if the time perspective code is Other. |
No |
Yes |
Yes |
Yes |
EID 12.33 |
number_of_groups |
The number of intervention groups/cohorts associated with the trial. Applies to non-interventional trials. |
No |
Yes |
Yes |
Yes |
EID 12.34 |
model_description |
This element provides any available details about the Interventional Study Model. |
TBD |
Yes |
Yes |
Yes |
EID 12.35 |
masking_description |
This element provides any available details about the masked parties. |
TBD |
Yes |
Yes |
Yes |
EID 12.36 |
no_masking |
This element indicates that all people involved in the study know the identity of the intervention assignment. |
TBD |
Yes |
Yes |
Yes |
EID 13.01 |
accepts_healthy_volunteers_indicator |
Indicate whether healthy volunteers may participate in the study. Healthy volunteers are people who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements. |
Yes |
Yes |
Yes |
Yes |
EID 13.02 |
study_population_description |
A description of the population from which the groups or cohorts will be selected (such as primary care clinic, community sample, or residents of a certain town). Applies to observational studies only. |
Yes |
Yes |
Yes |
Yes |
EID 13.03 |
sampling_method_code |
The sampling method code indicating the processes to select the study population. Applies to observational studies only. For details, check the trial's Detailed Description. |
Yes |
Yes |
Yes |
Yes |
EID 13.04 |
eligibility |
Eligibility criteria. |
Yes |
Yes |
Yes |
Yes |
EID 13.05 |
structured |
Structured eligibility criteria. |
Yes |
Yes |
Yes |
Yes |
EID 13.06 |
gender |
Physical gender of individuals who may participate in the protocol. |
Yes |
Yes |
Yes |
TBD |
EID 13.07 |
max_age |
Maximum age of participants. The value "999 Years" represents no maximum age. |
Yes |
Yes |
Yes |
TBD |
EID 13.08 |
max_age_number |
Provide a number for the maximum age of participants. |
Yes |
Yes |
Yes |
TBD |
EID 13.09 |
max_age_unit |
Select a unit of time for the maximum age of participants. |
Yes |
Yes |
Yes |
TBD |
EID 13.10 |
max_age_in_years |
Maximum age of participants, expressed in years. |
Yes |
No |
TBD |
TBD |
EID 13.11 |
min_age |
Minimum age of participants. The value "0 Years" represents no minimum age. |
Yes |
Yes |
Yes |
TBD |
EID 13.12 |
min_age_number |
Provide a number for the minimum age of participants. |
Yes |
Yes |
Yes |
TBD |
EID 13.13 |
min_age_unit |
Select a unit of time for the minimum age of participants. |
Yes |
Yes |
Yes |
TBD |
EID 13.14 |
min_age_in_years |
Minimum age of participants, expressed in years. |
Yes |
No |
TBD |
TBD |
EID 13.15 |
unstructured |
Unstructured eligibility criteria. |
Yes |
Yes |
Yes |
Yes |
EID 13.16 |
display_order |
The order in which the trial lists unstructured eligibility criteria. |
Yes |
No |
Yes |
TBD |
EID 13.17 |
inclusion_indicator (component of unstructured) |
Indicates whether the specified criterion (population description) is an inclusion indicator (t) or exclusion indicator (f) for participation in this trial. |
Yes |
No |
Yes |
TBD |
EID 13.18 |
description |
A description of the population included or exluded from the trial. |
Yes |
Yes |
Yes |
TBD |
EID 13.19 |
gender_based |
Indicates whether participant eligibility is based on self-representation of gender identity. |
TBD |
Yes |
Yes |
Yes |
EID 13.20 |
gender_description |
This element provides any available information about gender eligibility. |
TBD |
Yes |
Yes |
Yes |
EID 14.01 |
interventions |
The interventions being studied (administered) in the arm. |
Yes |
Yes |
Yes |
Yes |
EID 14.02 |
intervention_name |
The standard name of the intervention being studied. For a drug, this is the generic name. For an investigational new drug that does not yet have a generic name, this may be the chemical name, company code, or serial number. |
Yes |
Yes |
Yes |
Yes |
EID 14.03 |
intervention_type |
The general category or mode of the intervention being studied. |
Yes |
Yes |
Yes |
Yes |
EID 14.04 |
intervention_code |
The code (NCI Thesaurus Concept ID) of the intervention being studied. |
Yes |
No |
Yes |
Yes |
EID 14.05 |
intervention_description |
Succinctly describes the key details of the intervention. For drug interventions, a summary of the drug’s chemical nature and (potential) mechanism of action, and/or details such as dosage form, dosage, frequency, and duration. For other interventions, a summary of the procedure or device that provides key details that distinguish it from similar interventions. |
Yes |
Yes |
Yes |
Yes |
EID 14.06 |
synonyms (component of interventions) |
A comma-delimited list of alternative names for the intervention, including brand names, abbreviations, code names, and chemical structure. |
Yes |
Yes |
Yes |
Yes |
EID 15.01 |
arms |
A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins. Applies to interventional trials. |
Yes |
Yes |
Yes |
Yes |
EID 15.02 |
arm_name |
Label (short name) used to identify the arm or comparison group. |
Yes |
Yes |
Yes |
Yes |
EID 15.03 |
arm_type |
Function of the arm. |
Yes |
Yes |
Yes |
Yes |
EID 15.04 |
arm_description |
Brief description of the arm or comparison group, to distinguish it from other arms/groups in the trial. |
Yes |
Yes |
Yes |
Yes |
EID 16.01 |
name |
The name (or title) of an outcome measure. Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors, or treatment. The title is a concise name for the specific measure. |
Yes |
Yes |
Yes |
Yes |
EID 16.02 |
description |
Additional information about the outcome measure, if needed for clarification. |
Yes |
Yes |
Yes |
Yes |
EID 16.03 |
timeframe |
Time point(s) at which the outcome measure is assessed. |
Yes |
Yes |
Yes |
Yes |
EID 16.04 |
safety_indicator |
(Retired: Deprecated by FDAAA Final Rule April 2017) |
No |
(Retired) |
(Retired) |
(Retired) |
EID 16.05 |
type_code |
Indicates the outcome measure type. |
Yes |
Yes |
Yes |
Yes |
EID 17.01 |
group_code |
The label of a group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins. |
No |
Yes |
Yes |
Yes |
EID 17.02 |
description |
Specific subgroup stratification factors. |
No |
Yes |
Yes |
Yes |
EID 18.01 |
biomarkers |
Biomarkers for the trial. |
Yes |
Yes |
Yes |
Yes |
EID 18.02 |
assay_purpose |
Why the biomarker is being measured. |
Yes |
Yes |
Yes |
Yes |
EID 18.03 |
long_name |
Long name of the biomarker. |
Yes |
No |
Yes |
TBD |
EID 18.04 |
name (component of biomarkers) |
Name of biomarker in caDSR. |
Yes |
Yes |
Yes |
TBD |
EID 18.05 |
synonyms (component of biomarkers) |
Alternative names for the biomarker. |
Yes |
No |
TBD |
TBD |
EID 18.06 |
hugo_biomarker_code |
A unique ID for the biomarker within the Human Genome Organisation (HUGO) Gene Nomenclature Committee (HGNC) database. |
Yes |
No |
Yes |
TBD |
EID 18.07 |
nci_thesaurus_concept_id (component of biomarkers) |
A unique ID for the biomarker within the NCI Enterprise Vocabulary Service's (EVS) NCI Thesaurus (NCIt). |
Yes |
No |
Yes |
TBD |
EID 18.08 |
evaluation_type_code |
Method of biomarker evaluation. |
No |
Yes |
Yes |
Yes |
EID 18.09 |
assay_type_code |
How the biomarker is being measured. |
No |
Yes |
Yes |
Yes |
EID 18.10 |
assay_use |
How the biomarker is used in the trial. |
No |
Yes |
Yes |
Yes |
EID 18.11 |
type_code |
Describes the type of biospecimen for the biomarker. |
No |
Yes |
Yes |
Yes |
EID 19.01 |
sites |
Participating sites for a trial. |
Yes |
Yes |
Yes |
Yes |
EID 19.02 |
contact_email |
The email address for a specified participating site contact on a trial. |
Yes |
Yes |
Yes |
Yes |
EID 19.03 |
contact_name |
The name of a specified participating site contact on a trial. |
Yes |
Yes |
Yes |
TBD |
EID 19.04 |
contact_phone |
The office phone number for a specified participating site contact on a trial. |
Yes |
Yes |
Yes |
Yes |
EID 19.05 |
generic_contact |
Primary contact for a participating site. |
Yes |
Yes |
Yes |
TBD |
EID 19.06 |
recruitment_status |
The current stage or state of a participating site relative to other stages and its ability to enroll participants / patients. Protocol accrual activity at a facility. |
Yes |
Yes |
Yes |
Yes |
EID 19.07 |
recruitment_status_date |
The date associated with the participating site's current site recruitment status. |
Yes |
Yes |
Yes |
Yes |
EID 19.08 |
local_site_identifier |
The unique ID assigned to the trial by the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.09 |
org_address_line_1 |
The first part of an address for the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.10 |
org_address_line_2 |
The second part of an address for the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.11 |
org_city |
The city of the participating site. |
Yes |
Yes |
Yes |
Yes |
EID 19.12 |
org_country |
The country of the participating site. |
Yes |
Yes |
Yes |
Yes |
EID 19.13 |
org_email |
The email address of the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.14 |
org_family |
The organization family of the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.15 |
org_fax |
The fax number of the participating site. |
Yes |
No |
Yes |
TBD |
EID 19.16 |
org_name |
The full name of the participating site (the organization where the protocol is being conducted). |
Yes |
Yes |
Yes |
Yes |
EID 19.17 |
org_to_family_relationship |
The relationship of the participating site organization to its family. |
Yes |
No |
Yes |
Yes |
EID 19.18 |
org_phone |
The phone number of the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.19 |
org_postal_code |
The postal code of the participating site. |
Yes |
Yes |
Yes |
Yes |
EID 19.20 |
org_state_or_province |
The two-letter abbreviation for the participating site's state or province. |
Yes |
Yes |
Yes |
Yes |
EID 19.21 |
org_status |
The organization status of the participating site. |
Yes |
No |
Yes |
Yes |
EID 19.22 |
org_status_date |
The date associated with the participating site's organization status. |
Yes |
No |
Yes |
Yes |
EID 19.23 |
org_tty |
The TTY number of the participating site. |
Yes |
No |
Yes |
TBD |
EID 19.24 |
org_coordinates |
The geographic coordinates of the participating site. |
Yes |
No |
TBD |
TBD |
EID 19.25 |
org_po_id |
Unique ID for the participating site organization, assigned by CTRP. |
No |
Yes |
Yes |
Yes |
EID 19.26 |
investigator_last_name |
The principal investigator for a trial at a participating site. |
No |
Yes |
Yes |
Yes |
EID 19.27 |
target_accrual |
The anticipated (target) number of subjects in the trial at the participating site. |
No |
Yes |
Yes |
Yes |
EID 20.01 |
code_system |
The disease terminology code currently in use for accruals. |
No |
No |
Yes |
Yes |
EID 20.02 |
subject_identifier |
Unique ID assigned to the patient for the study. |
No |
No |
Yes |
Yes |
EID 20.03 |
zip |
The study subject's postal code. In the US, the postal code is the string of characters used to identify the five-digit Zone Improvement Plan (ZIP) code, assigned by the US Postal Service to facilitate mail delivery. If the subject is a US resident, the postal code is mandatory. |
No |
No |
TBD |
Yes |
EID 20.04 |
country |
The study subject's country. The name of a country from which a person or their biological family had previous residence or ancestors. If the subject is not a US resident, the country is mandatory. |
No |
No |
Yes |
Yes |
EID 20.05 |
birth_date |
The study subject's month and year of birth. |
No |
No |
TBD |
Yes |
EID 20.06 |
gender |
Text designations that identify the study subject's gender. Gender is described as the assemblage of properties that distinguish people on the basis of their societal roles. |
No |
No |
Yes |
Yes |
EID 20.07 |
race |
Text designations that identify the study subject's race, based on the Office of Management and Budget (OMB) categories. |
No |
No |
Yes |
Yes |
EID 20.08 |
ethnicity |
Text designations that identify the study subject's ethnicity, based on the Office of Management and Budget (OMB) categories. |
No |
No |
Yes |
Yes |
EID 20.09 |
payment_method |
Text designations that identify the study subject's payment method. An entity, organization, government, corporation, health plan sponsor, or any other financial agent who pays a healthcare provider for the healthcare service rendered to a person or reimburses the cost of the healthcare service. |
No |
No |
Yes |
Yes |
EID 20.10 |
registration_date |
Date the subject was registered for the study. |
No |
No |
Yes |
Yes |
EID 20.11 |
registration_group |
Unique ID assigned by CTRP (PO ID) to the organization that originally registered the patient for the study. |
No |
No |
Yes |
Yes |
EID 20.12 |
site_org_id |
Unique ID (numeric or alphanumeric) assigned to the study site. |
No |
No |
Yes |
Yes |
EID 20.13 |
preferred_name |
The study subject's diagnosed disease or condition. Diseases are neoplastic or nonneoplastic conditions, disorders, syndromes, illnesses, or injuries. Conditions include any health issue that is the subject of a clinical protocol. |
No |
No |
Yes |
Yes |
EID 20.14 |
accrual_count |
The actual number of subjects accrued on the trial at the participating site to date. |
No |
No |
Yes |
Yes |
EID 20.15 |
targeted_accrual |
The anticipated (target) number of subjects for the trial for all participating sites in a Cancer Center Family. |
No |
No |
Yes |
Yes |
