Registration Data Model

  1. Registration Data Model
    1. Administrative fields
    2. Scientific fields
    3. Adittional required fields
    4. Additional fields

Mapping of the 20 TRDS fields to XML elements and database entities.

Administrative fields

TRDS wiki name XML element required repeat max.len. model class attribute name type search
1 PrimaryIdNumberField trial_id A N 255 ClinicalTrial trial_id Char(255) (1) basic *
2 RegistrationDateField date_registration A N 10 ClinicalTrial date_registration Date adv.
3a SecondaryIdNumbersField issuing_authority Y(a) Y 255 TrialNumber trial_number_set ← TrialNumber set (2))
3b secondary_id 50 basic
4 SupportSourcesField source_name Y Y 1000 Institution source_name_set ← Institution set (2) basic (name only)
5 PrimarySponsorField primary_sponsor Y N 2000 ClinicalTrial primary_sponsor ForeignKey(Institution) basic (name only)
6 SecondarySponsorsField sponsor_name N Y 2000 Institution secondary_sponsor_set ← Institution set (2) basic (name only)
7 PublicContactField contact type="public" (3) N Y 1370 (4) Contact public_contact_set ← Contact set (2) basic (city) adv. (name only)
contact type="site" (3) ? Y 1370 (4) Contact site_contact_set ← Contact set (2) basic (city)
8 ScientificContactField contact type="scientific" (3) Y Y 1370 (4) Contact scientific_contact_set ← Contact set (2) adv. (name only)
9a PublicTitleField public_title N N 2000 ClinicalTrial public_title Char(2000) basic *
9b acronym N N 255 ClinicalTrial acronym Char(255) basic
acronym_expansion N N 255 ClinicalTrial acronym_expansion Char(255) basic
10a ScientificTitleField scientific_title Y N 2000 ClinicalTrial scientific_title Char(2000) basic
10b scientific_acronym N N 255 ClinicalTrial scientific_acronym Char(255) basic
scientific_acronym_expansion N N 255 ClinicalTrial scientific_acronym_expansion Char(255) basic
11 RecruitmentCountriesField country2 Y Y 50 RecruitmentCountry recruitment_country_set ← RecruitmentCountry set (2) basic

(a) Required Secondary IDs: UTN issued by ICTRP/WHO; Number of letter of approval ("parecer") issued by IRB/ethics committee

Scientific fields

TRDS wiki name XML element required repeat max.len. model class attribute name type
12a HealthConditionsField hc_freetext Y N 8000 ClinicalTrial hc_freetext Char(8000) basic
12b hc_code Y Y 255 ConditionTag hc_category_set ← ConditionTag set (2) basic
12c hc_keyword Y Y 255 ConditionTag hc_keyword_set ← ConditionTag set (2) basic
13a InterventionsField i_freetext Y N 8000 ClinicalTrial i_freetext Char(8000) basic
13b i_code Y Y 255 InterventionTag i_category_set ← InterventionTag set (2) basic
13c i_keyword Y Y 255 InterventionTag i_keyword_set ← InterventionTag set (2) basic
14a InclusionCriteriaField inclusion_criteria Y Y 8000 ClinicalTrial inclusion_criteria Char(8000) basic
14b gender Y N 50 ClinicalTrial gender Char(50) adv.
14c agemin Y Y 50 ClinicalTrial agemin_value PositiveInteger adv.
Y Y ClinicalTrial agemin_unit Char(1) adv.
14d agemax Y N 50 ClinicalTrial agemax_value PositiveInteger adv.
Y N ClinicalTrial agemin_unit Char(1) adv.
14e exclusion_criteria Y Y 8000 ClinicalTrial exclusion_criteria Char(8000) adv.
15a StudyTypeField study_type Y N 255 ClinicalTrial study_type Char(255) adv.
15b study_design Y N 1000 ClinicalTrial study_design Char(1000) basic
15c phase Y N 255 ClinicalTrial phase Char(255) adv.
16a FirstEnrollmentDateField type_enrollment Y Y (5) 50
16b date_enrollment Y Y (5) 10 ClinicalTrial enrollment_start_planned Char(10) (6) adv.
N ClinicalTrial enrollment_start_actual Char(10) (6) adv.
Y ClinicalTrial enrollment_end_planned Char(10) (6) adv.
N ClinicalTrial enrollment_end_actual Char(10) (6) adv.
17 SampleSizeField target_size Y N 255 ClinicalTrial target_sample_size PositiveInteger() adv.
18 RecruitmentStatusField recruitment_status Y N 255 ClinicalTrial recruitment_status Char(255) basic (currently recruiting) *
19 PrimaryOutcomesField primary_outcome Y Y 8000 Outcome primary_outcome_set ← Outcome set (2) basic
20 SecondaryOutcomesField secondary_outcome Y Y 8000 Outcome secondary_outcome_set ← Outcome set (2) basic

(*) fields to show in the basic search result. Other fields to show: updating_date

Adittional required fields

ICTRP-DF name XML element repeat max.len. model class attribute name type
A1 URL url N 255 ClinicalTrial canonical_url ClinicalTrial method (7)

(1) The maximum length of the trial_id and the secondary_id should be the same, to ensure interoperability among registries.

(2) Dynamic attribute: record set from a related table with ForeignKey(ClinicalTrial).

(3) The name of this element is not given in the WHO TRDS version 1.1 specification.

(4) Aggregate field. Number shown is the total of subfields per ICTRP Data format version 1.1.

(5) Two pairs of these elements are allowed, one with <type_enrollment>anticipated</type_enrollment> and the other with <type_enrollment>actual</type_enrollment>. In the database model, each pair becomes a single field.

(6) A DateField cannot be used because only month and year are required.

(7) A permalink decorated method calculates the canonical URL for the trial (i.e. get_absolute_url of the default view for a ClinicalTrial)

== OpenTrials XML

We have refactored the old "RECLAC" XML standard to a new one (with a new name), updated to current fields, you can get more informations about it in OpenTrialsXML.

Additional fields

Attachments