Registration Data Model

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

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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	Y	255	TrialNumber	trial_number_set	← TrialNumber set (2))
3b		secondary_id	?	Y	50				basic
4	SupportSourcesField	source_name	?	Y	1000	Institution	source_name_set	← Institution set (2)	basic (name only)
5	PrimarySponsorField	primary_sponsor	?	N	2000	ClinicalTrial	primary_sponsor	ForeignKey(Institution)	basic (name only)
6	SecondarySponsorsField	sponsor_name	?	Y	2000	Institution	secondary_sponsor_set	← Institution set (2)	basic (name only)
7	PublicContactField	contact type="public" (3)	?	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	1370 (4)	Contact	scientific_contact_set	← Contact set (2)	adv. (name only)
9a	PublicTitleField	public_title	?	N	2000	ClinicalTrial	public_title	Char(2000)	basic *
9b		acronym	?	N	255	ClinicalTrial	acronym	Char(255)	basic
		acronym_expansion	?	N	255	ClinicalTrial	acronym_expansion	Char(255)	basic
10a	ScientificTitleField	scientific_title	?	N	2000	ClinicalTrial	scientific_title	Char(2000)	basic
10b		scientific_acronym	?	N	255	ClinicalTrial	scientific_acronym	Char(255)	basic
		scientific_acronym_expansion	?	N	255	ClinicalTrial	scientific_acronym_expansion	Char(255)	basic
11	RecruitmentCountriesField	country2	?	Y	50	RecruitmentCountry	recruitment_country_set	← RecruitmentCountry set (2)	basic

(a) Required Secondary IDs: UTN issued by ICTRP/WHO;

Scientific fields

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

Additional fields

• StudyStatus
• CompletionDate
• InstitutionData
• SubmissionData
• SiteContact