The ECX Document Format — Version 1.3

An ecx document is a ZIP file that contains a single JSON encoded data file (data.json) and any number of auxiliary data files. The zip container MAY use compression.

The current specification only uses data files for attached documents. They SHOULD be stored below an attachments/ directory inside the ZIP archive. JSON fields that have a null value, MAY be ommitted from the document.

The suggested file extension is ecx, the mimetype application/ecx.

data.json

version STRING, MUST be "1.3"
type STRING, MUST be "SubmissionForm"
data OBJECT
additional_therapy_info STRING (6.3 Additional information on study-related activities and any necessary deviations from the routine treatment)
already_voted BOOLEAN (2.8 There are already votes of other ethics commissions.)
clinical_phase STRING max. 10 characters, may be null (2.5 Clinical Phase)
created_at STRING RFC 3339 with timezone UTC+1 (e.g. 2010-07-14T16:04:35+01:00)
documents OBJECT[]
date STRING RFC 3339 with timezone UTC+1 (e.g. 2010-07-14T16:04:35+01:00) ( date of document creation)
doctype STRING - choices:
"Covering Letter"
Covering Letter
"patient information"
patient information
"insurancecertificate"
insurancecertificate
"study protocol"
study protocol
"Investigator's Brochure"
Investigator's Brochure
"Amendment"
Amendment
"Curriculum Vitae (CV)"
Curriculum Vitae (CV)
"Conflict of Interest"
Conflict of Interest
"Case Report Form (CRF)"
Case Report Form (CRF)
"EudraCT Form"
EudraCT Form
"adverse reaction report"
adverse reaction report
"Statement on a review"
Statement on a review
"Questionnaire"
Questionnaire
"Signed Page"
Signed Page
"Manual"
Manual
"Declaration of conformity"
Declaration of conformity
"other"
other
"Submission Form"
Submission Form
"Checklist"
Checklist
"vote"
vote
"Notification"
Notification
"Notification Answer"
Notification Answer
"Invoice"
Invoice
"Checklist Payment"
Checklist Payment
"Meeting Protocol"
Meeting Protocol
"Meeting ZIP"
Meeting ZIP
mimetype STRING max. 100 characters
name STRING max. 250 characters
original_file_name STRING max. 250 characters, may be null ( file name)
version STRING max. 250 characters ( version)
eudract_number STRING max. 60 characters, may be null (1.2.1 EudraCT-Nr.)
foreignparticipatingcenter_set OBJECT[]
investigator_name STRING max. 60 characters ( investigator)
name STRING max. 60 characters ( name)
german OBJECT
abort_info STRING may be null (7.19 Rules for the suspension or premature termination of the study at the test center, at the Member State or the entire study)
additional_info STRING may be null (7.22 additional information)
aftercare_info STRING may be null (7.17 Plan for treatment or care after the person has completed their participation in the study)
benefits_info STRING may be null (7.11 Expected benefits for the included test participants)
concurrent_study_info STRING may be null (7.13 Procedures on the site, to determine whether a person at a time to be included in another study, participate or whether a required period of time has elapsed since a participation in another study)
consent_info STRING may be null (7.9 Approach at test center(s), for informing and obtaining an informed consent of candidates)
dataaccess_info STRING may be null (7.20 Agreement on access of the examiner(s) to data, publication guidelines, etc)
dataprotection_info STRING may be null (7.16 Methods used to protect the confidentiality of the data collected, the source documents and the samples)
ethical_info STRING may be null (7.6 ethical considerations)
financing_info STRING may be null (7.21 Financing of the study and information on financial or other interests of the examiner)
inclusion_exclusion_crit STRING may be null (7.5 Relevant in- and exclusion criteria)
payment_info STRING may be null (7.18 Amount and method of compensation or remuneration to the test participants)
preclinical_results STRING may be null (7.3 Results of pre-clinical tests or justification for the waiving of pre-clinical tests)
primary_hypothesis STRING may be null (7.4 Primary hypothesis of the study)
project_title STRING may be null (7.1 project title (kraut-speak))
protected_subjects_info STRING may be null (7.7 Justification for the inclusion of persons from protected groups)
recruitment_info STRING may be null (7.8 Description of the recruitment process)
relationship_info STRING may be null (7.12 Relation between subject and investigator)
risks_info STRING may be null (7.10 Risk assessment)
sideeffects_info STRING may be null (7.14 Methods to identify, record, and report undesirable effects)
statistical_info STRING may be null (7.15 Statistical considerations and reasons for the number of people who should be included in the study)
summary STRING may be null (7.2 project summary)
insurance OBJECT
address STRING max. 80 characters, may be null (5.1.2 address)
contract_number STRING max. 60 characters, may be null (5.1.4 policy number)
name STRING max. 125 characters, may be null (5.1.1 insurance company)
not_required BOOLEAN ( No insurance is required)
phone STRING max. 30 characters, may be null (5.1.3 phone)
validity STRING max. 60 characters, may be null (5.1.5 validity)
investigators OBJECT[]
certified BOOLEAN (10.9 certified)
contact_first_name STRING max. 30 characters (10.1 first name of the Investigator)
contact_gender STRING max. 1 characters, may be null (10.1 salutation of the Investigator) - choices:
"f"
Ms
"m"
Mr
contact_last_name STRING max. 30 characters (10.1 last name of the Investigator)
contact_title STRING max. 30 characters (10.1 title of the Investigator)
email STRING max. 254 characters (10.6 e-mail)
employees OBJECT[]
firstname STRING max. 40 characters ( first name)
organisation STRING max. 80 characters ( Institution)
sex STRING max. 1 characters ( Ms/Mr) - choices:
"m"
Mr
"f"
Ms
surname STRING max. 40 characters ( last name)
title STRING max. 40 characters ( title)
ethics_commission STRING - choices:
"23d805c6b5f14d8b9196a12005fd2961"
Ethikkommission der Medizinischen Universität Wien
"7b51f38bde8a4161a0dc34647fc7e654"
Ethikkommission Krankenhaus Barmh.Brüder - Wien
"85dc386061584fbe8549ce4e4d828fbd"
Ethikkommission der Stadt Wien gemäß KAG, AMG und MPG
"d6a22c635a584521b107481ac18318f6"
Ethikkommission Forschungsinstitut des Wiener Roten Kreuzes
"55ae93ec9df04d6abfc8d233ec5ccf8e"
Nicht verwenden: Ethikkommission Krankenhaus Barmh.Schwestern - Wien
"7cd6d52120b3474ba502931b9f60a5f3"
Ethikkommission Confraternität-Priv.Klin. Josefstadt und Priv.Klin. Döbling
"7df9ebaf15434709b09c3def9a6c8769"
Ethikkommission St.Anna Kinderspital
"f122f144616541d391fde2dcc761aff4"
Ethikkommission Österreichische Arbeitsgemeinschaft für Klinische Pharmakologie
"25b6744780434a3f96a1e43b405d3848"
Ethikkommission Privatkrankenanstalt Rudolfinerhaus
"d542994ced34403db841786a1c1ab892"
Ethikkommission Rheuma-Zentrum Wien-Oberlaa
"5615dfbaf8c8445d960d1e2cd9c00dc3"
Nicht verwenden: Ethikkommission Krankenhaus des Göttlichen Heilandes
"4d3a2d5f138940f293ee87fe6ec1d5b2"
Ethikkommission Evangelisches Krankenhaus
"8d2950e3a0294f68bde647a54df6d823"
Ethikkommission der Allgemeinen Unfallversicherungsanstalt
"9f6b509e716e413f865d95bdd630e9bc"
Ethikkommission Immunologische Tagesklinik
"b17f32f604fa4452b5ff3a2baa9e0704"
Ethikkommission des Landes Niederösterreich
"6688ce16a3b84d42b1531389e6039891"
Ethikkommission Krankenhaus Elisabethinen
"e4dcd05a31ad475ca72dea7b84ef030e"
Ethikkommission des Landes Oberösterreich
"e269491bb9c040aaad6a5f11df343f38"
Ethikkommission Krankenhaus Barmh.Brüder - Linz
"1cca34032077445d95dabf7802fade28"
Ethikkommission Krankenhaus Barmh.Schwestern - Linz
"39cbb589ef044d27bceb6ee5ac796ae7"
Ethikkommission für das Bundesland Salzburg
"280414583b894c809a9baa8134d7fe4b"
Ethikkommission der Medizinischen Universität Innsbruck
"183881da8200493aa7edd8bebeea75b9"
Ethikkommission des Landes Vorarlberg
"95821eba88f34b2195f96e747d7f6b16"
Ethikkommission des Landes Burgenland gemäß KAG, AMG und MPG
"6e7cfab5f8cd40df83c9de4fac9bb20f"
Ethikkommission des Landes Steiermark gemäß AMG und MPG
"75b5a9714f354a5b842aa01029148036"
Ethikkommission Krankenhaus Barmh.Brüder - Graz
"9287fb0878b94f9f9d90b5582d1cefca"
Ethikkommission Krankenhaus Barmh.Brüder - Eggenberg
"e17ee744e4e840778f316cf3f79de6b4"
Ethikkommission der Medizinischen Universität Graz
"ec9f179a52a04a7aa52446232c3fd4bd"
Ethikkommission des Landes Kärnten
"c890205dcb7543c8a76bf324512c5f81"
Nicht verwenden: Ethikkommission des Krankenhaus St. Josef
"dc1b115d9809461ba3ea9450b079ddd6"
Kommission für Scientific Integrity und Ethik der Karl Landsteiner Privatuniversität
"50dba0126a0746dc8802e6c0e0199dad"
Ethik-Kommission der Vinzenz Gruppe Wien
fax STRING max. 30 characters (10.5 FAX)
jus_practicandi BOOLEAN (10.7 Jus practicandi)
main BOOLEAN ( principal investigator)
mobile STRING max. 30 characters (10.4 mobile)
organisation STRING max. 80 characters (10.2 study site)
phone STRING max. 30 characters (10.3 phone)
specialist STRING max. 80 characters (10.8 specialist for)
subject_count INTEGER (11. number of participants)
invoice OBJECT
address STRING max. 60 characters, may be null (1.5.2 address)
city STRING max. 80 characters, may be null (1.5.2 city)
contact_first_name STRING max. 30 characters (1.5.3 first name of contact person)
contact_gender STRING max. 1 characters, may be null (1.5.3 sex of contact person) - choices:
"f"
Ms
"m"
Mr
contact_last_name STRING max. 30 characters (1.5.3 last name of contact person)
contact_title STRING max. 30 characters (1.5.3 title of contact person)
email STRING max. 254 characters, may be null (1.5.6 e-mail)
fax STRING max. 45 characters, may be null (1.5.5 fax)
name STRING max. 160 characters, may be null (1.5.1 invoice name)
phone STRING max. 50 characters, may be null (1.5.4 telephone)
uid STRING max. 35 characters, may be null (1.5.7 UID-Number)
zip_code STRING max. 10 characters, may be null (1.5.2 postal code)
measures OBJECT[]
category STRING max. 3 characters ( study reference) - choices:
"6.1"
only study-related
"6.2"
for routine purposes
count STRING max. 150 characters ( number/dose)
period STRING max. 30 characters ( period)
total STRING max. 30 characters ( total)
type STRING max. 150 characters ( type)
medtech OBJECT
ce_symbol STRING may be null (4.5 The medical product carries a CE mark)
certified_for_exact_indications STRING may be null (4.3 Certified for this indication)
certified_for_other_indications STRING may be null (4.4 Certified, but for another indication)
checked_product STRING may be null (2.4.1 Test products(e))
departure_from_regulations STRING may be null (4.8 Any deviations from the above provisions (standards))
manual_included STRING may be null (4.6 The product brochure is included.)
manufacturer STRING max. 80 characters, may be null (4.2 Manufacturer)
product_name STRING max. 210 characters, may be null (4.1 Name of the product)
reference_substance STRING may be null (2.4.2 reference product)
technical_safety_regulations STRING may be null (4.7 What rules or standards have been used for the construction and testing of the medical product (technical safety))
nontesteduseddrug_set OBJECT[]
dosage STRING max. 40 characters ( dosage)
generic_name STRING max. 40 characters ( Generic Name)
preparation_form STRING max. 40 characters ( dosage Form)
participatingcenternonsubject_set OBJECT[]
ethics_commission STRING - choices:
"23d805c6b5f14d8b9196a12005fd2961"
Ethikkommission der Medizinischen Universität Wien
"7b51f38bde8a4161a0dc34647fc7e654"
Ethikkommission Krankenhaus Barmh.Brüder - Wien
"85dc386061584fbe8549ce4e4d828fbd"
Ethikkommission der Stadt Wien gemäß KAG, AMG und MPG
"d6a22c635a584521b107481ac18318f6"
Ethikkommission Forschungsinstitut des Wiener Roten Kreuzes
"55ae93ec9df04d6abfc8d233ec5ccf8e"
Nicht verwenden: Ethikkommission Krankenhaus Barmh.Schwestern - Wien
"7cd6d52120b3474ba502931b9f60a5f3"
Ethikkommission Confraternität-Priv.Klin. Josefstadt und Priv.Klin. Döbling
"7df9ebaf15434709b09c3def9a6c8769"
Ethikkommission St.Anna Kinderspital
"f122f144616541d391fde2dcc761aff4"
Ethikkommission Österreichische Arbeitsgemeinschaft für Klinische Pharmakologie
"25b6744780434a3f96a1e43b405d3848"
Ethikkommission Privatkrankenanstalt Rudolfinerhaus
"d542994ced34403db841786a1c1ab892"
Ethikkommission Rheuma-Zentrum Wien-Oberlaa
"5615dfbaf8c8445d960d1e2cd9c00dc3"
Nicht verwenden: Ethikkommission Krankenhaus des Göttlichen Heilandes
"4d3a2d5f138940f293ee87fe6ec1d5b2"
Ethikkommission Evangelisches Krankenhaus
"8d2950e3a0294f68bde647a54df6d823"
Ethikkommission der Allgemeinen Unfallversicherungsanstalt
"9f6b509e716e413f865d95bdd630e9bc"
Ethikkommission Immunologische Tagesklinik
"b17f32f604fa4452b5ff3a2baa9e0704"
Ethikkommission des Landes Niederösterreich
"6688ce16a3b84d42b1531389e6039891"
Ethikkommission Krankenhaus Elisabethinen
"e4dcd05a31ad475ca72dea7b84ef030e"
Ethikkommission des Landes Oberösterreich
"e269491bb9c040aaad6a5f11df343f38"
Ethikkommission Krankenhaus Barmh.Brüder - Linz
"1cca34032077445d95dabf7802fade28"
Ethikkommission Krankenhaus Barmh.Schwestern - Linz
"39cbb589ef044d27bceb6ee5ac796ae7"
Ethikkommission für das Bundesland Salzburg
"280414583b894c809a9baa8134d7fe4b"
Ethikkommission der Medizinischen Universität Innsbruck
"183881da8200493aa7edd8bebeea75b9"
Ethikkommission des Landes Vorarlberg
"95821eba88f34b2195f96e747d7f6b16"
Ethikkommission des Landes Burgenland gemäß KAG, AMG und MPG
"6e7cfab5f8cd40df83c9de4fac9bb20f"
Ethikkommission des Landes Steiermark gemäß AMG und MPG
"75b5a9714f354a5b842aa01029148036"
Ethikkommission Krankenhaus Barmh.Brüder - Graz
"9287fb0878b94f9f9d90b5582d1cefca"
Ethikkommission Krankenhaus Barmh.Brüder - Eggenberg
"e17ee744e4e840778f316cf3f79de6b4"
Ethikkommission der Medizinischen Universität Graz
"ec9f179a52a04a7aa52446232c3fd4bd"
Ethikkommission des Landes Kärnten
"c890205dcb7543c8a76bf324512c5f81"
Nicht verwenden: Ethikkommission des Krankenhaus St. Josef
"dc1b115d9809461ba3ea9450b079ddd6"
Kommission für Scientific Integrity und Ethik der Karl Landsteiner Privatuniversität
"50dba0126a0746dc8802e6c0e0199dad"
Ethik-Kommission der Vinzenz Gruppe Wien
investigator_name STRING max. 60 characters ( investigator)
name STRING max. 60 characters ( name)
pharma_checked_substance STRING may be null (2.3.1 Test substances)
pharma_reference_substance STRING may be null (2.3.2 Reference substance)
project_title STRING (1.1 project title (english))
project_type OBJECT
basic_research BOOLEAN (2.1.5 Non-therapeutic biomedical research involving human subjects (basic research))
biobank BOOLEAN (2.1.11 Biobank)
education_context INTEGER may be null (2.1.8/9 Dissertation / Thesis) - choices:
1
Dissertation
2
Diplomarbeit
gender_medicine BOOLEAN (2.1.17 Gender medicine)
genetic_study BOOLEAN (2.1.6 Genetic survey)
medical_device BOOLEAN (2.1.4 Clinical investigation of medical devices)
medical_device_performance_evaluation BOOLEAN (2.1.4.3 Performance evaluation (in-vitro diagnostics))
medical_device_with_ce BOOLEAN (2.1.4.1 with CE-marking)
medical_device_without_ce BOOLEAN (2.1.4.2 without CE-marking)
medical_method BOOLEAN (2.1.3 Clinical testing of a new medical method)
misc STRING may be null (2.1.7 Other, please specify)
non_interventional_study BOOLEAN (2.1.16 Non-interventional Study (NIS))
non_reg_drug BOOLEAN (2.1.1 Clinical trial of an unregistered drug)
nursing_study BOOLEAN (2.1.15 Nursing Scientific Study)
psychological_study BOOLEAN (2.1.14 Psychological study)
questionnaire BOOLEAN (2.1.13 Questionnaire investigation)
reg_drug BOOLEAN (2.1.2 Clinical testing of a registered product)
reg_drug_not_within_indication BOOLEAN (2.1.2.2 not according to the indication)
reg_drug_within_indication BOOLEAN (2.1.2.1 according to the indication)
register BOOLEAN (2.1.10 Register)
retrospective BOOLEAN (2.1.12 Retrospective data analysis)
specialism STRING may be null (2.2 special field)
sponsor OBJECT
address STRING max. 60 characters, may be null (1.5.2 address)
city STRING max. 80 characters, may be null (1.5.2 city)
contact_first_name STRING max. 30 characters (1.5.3 first name of contact person)
contact_gender STRING max. 1 characters, may be null (1.5.3 sex of contact person) - choices:
"f"
Ms
"m"
Mr
contact_last_name STRING max. 30 characters (1.5.3 last name of contact person)
contact_title STRING max. 30 characters (1.5.3 title of contact person)
email STRING max. 254 characters, may be null (1.5.6 e-mail)
fax STRING max. 30 characters, may be null (1.5.5 fax)
name STRING max. 100 characters, may be null (1.5.1 sponsor name)
phone STRING max. 30 characters, may be null (1.5.4 telephone)
uid STRING max. 35 characters, may be null (1.5.7 UID-Number)
zip_code STRING max. 10 characters, may be null (1.5.2 postal code)
study_plan OBJECT
abort_crit STRING max. 265 characters, may be null (8.3.3 Termination criteria)
alpha STRING max. 80 characters (8.2.1 Alpha)
alpha_sided INTEGER may be null ( ) - choices:
0
single-sided
1
double-sided
alternative_hypothesis STRING may be null (8.1.21 alternative hypothesis)
biometric_planning STRING max. 260 characters (8.5.1 Who did the biometric planning (if applicable, proof of qualification)?)
blind INTEGER ( Open / Blind / Double-blind) - choices:
0
open
1
blind
2
double-blind
3
not applicable
controlled BOOLEAN (8.1.6 controlled)
cross_over BOOLEAN (8.1.7 cross-over)
datamanagement STRING (8.4.2 Information on data management)
dataprotection_anonalgoritm STRING may be null (8.6.3 How is the anonymization done?)
dataprotection_choice STRING max. 15 characters (8.6.1 Information privacy) - choices:
"personal"
individual-related
"non-personal"
implicit individual-related
"anonymous"
completely anonymous
dataprotection_dvr STRING max. 180 characters, may be null (8.6.2 DPR-Nr.)
dataprotection_reason STRING max. 120 characters, may be null (8.6.2 Justification)
dataquality_checking STRING (8.4.1 Information on the data quality audit)
dropout_ratio STRING max. 80 characters (8.2.5 Expected number of study dropouts(Drop-out-Quota))
equivalence_testing BOOLEAN (8.1.14 equivalence testing)
factorized BOOLEAN (8.1.11 factorized)
interim_evaluation BOOLEAN (8.3.3 Interim evaluation)
misc STRING may be null (8.1.15 misc)
multiple_test BOOLEAN (8.2.4 multiple testing)
multiple_test_correction_algorithm STRING max. 100 characters, may be null (8.2.4 correctionalgorithm)
null_hypothesis STRING may be null (8.1.20 null hypothesis)
number_of_groups STRING may be null (8.1.16 number of groups)
observer_blinded BOOLEAN (8.1.13 observer-blinded)
parallelgroups BOOLEAN (8.1.3 parallel groups)
pilot_project BOOLEAN (8.1.12 pilot project)
placebo BOOLEAN (8.1.10 placebo)
planned_statalgorithm STRING may be null (8.3.4 Planned use of statistical methods)
population_intention_to_treat BOOLEAN (8.3.1 Intention-to-treat)
population_per_protocol BOOLEAN (8.3.2 Per Protocol)
power STRING max. 80 characters (8.2.2 Power)
primary_objectives STRING may be null (8.1.19 primary objectives)
randomized BOOLEAN (8.1.2 randomized)
sample_frequency STRING may be null (8.1.18 sample frequency)
secondary_objectives STRING may be null (8.1.22 secondary objectives)
statalgorithm STRING max. 80 characters (8.2.3 statistical algorithm)
statistics_implementation STRING max. 270 characters (8.5.2 Who will conduct the statistical analysis (if applicable, proof of qualification)?)
stratification STRING may be null (8.1.17 stratification)
subject OBJECT
childbearing BOOLEAN (2.10.5 women of childbearing age)
count INTEGER (2.9 Planned number of trial participants total)
duration STRING max. 200 characters (2.11 Duration of participation of the individual test participants in the study)
duration_active STRING max. 200 characters (2.11.1 active phase)
duration_controls STRING max. 200 characters, may be null (2.11.2 Follow-up inspections)
females BOOLEAN (2.10.4 female participants)
males BOOLEAN (2.10.4 male participants)
maxage INTEGER may be null (2.10.2 maximum age)
minage INTEGER may be null (2.10.1 minimum age)
noncompetents BOOLEAN (2.10.3 non competent participants)
planned_total_duration STRING max. 250 characters (2.12 Expected total duration of the study)
submission OBJECT
ec_number INTEGER
submission_type INTEGER may be null ( Submit as) - choices:
1
monocentric
2
multicentric, main ethics commission
6
multicentric, local ethics commission
submitter OBJECT
contact_first_name STRING max. 30 characters (9.1 first name)
contact_gender STRING max. 1 characters, may be null (9.1 salutation) - choices:
"f"
Ms
"m"
Mr
contact_last_name STRING max. 30 characters (9.1 last name)
contact_title STRING max. 30 characters (9.1 title)
email STRING max. 254 characters, may be null ( e-mail)
is_authorized_by_sponsor BOOLEAN (9.4.4 The submitter is a person/organization authorized by the sponsor)
is_coordinator BOOLEAN (9.4.1 The submitter is a coordinating examiner (multicentric study))
is_main_investigator BOOLEAN (9.4.2 The submitter is a principal investigator (monocentric study))
is_sponsor BOOLEAN (9.4.3 The submitter is a sponsor / representative of the sponsor)
jobtitle STRING max. 130 characters (9.3 position)
organisation STRING max. 180 characters (9.2 Institution / Company)
substance OBJECT
p_c_t_application_type STRING max. 145 characters, may be null (3.2.4 application type(s))
p_c_t_countries STRING[] max. 2 characters (3.2.1 3.2.1 Countries in which the tests were conducted) - choices:
"AF"
Afghanistan
"AX"
Åland Islands
"AL"
Albania
"DZ"
Algeria
"AS"
American Samoa
"AD"
Andorra
"AO"
Angola
"AI"
Anguilla
"AQ"
Antarctica
"AG"
Antigua and Barbuda
"AR"
Argentina
"AM"
Armenia
"AW"
Aruba
"AU"
Australia
"AT"
Austria
"AZ"
Azerbaijan
"BS"
Bahamas
"BH"
Bahrain
"BD"
Bangladesh
"BB"
Barbados
"BY"
Belarus
"BE"
Belgium
"BZ"
Belize
"BJ"
Benin
"BM"
Bermuda
"BT"
Bhutan
"BO"
Bolivia
"BQ"
Bonaire, Sint Eustatius and Saba
"BA"
Bosnia and Herzegovina
"BW"
Botswana
"BV"
Bouvet Island
"BR"
Brazil
"IO"
British Indian Ocean Territory
"BN"
Brunei
"BG"
Bulgaria
"BF"
Burkina Faso
"BI"
Burundi
"CV"
Cabo Verde
"KH"
Cambodia
"CM"
Cameroon
"CA"
Canada
"KY"
Cayman Islands
"CF"
Central African Republic
"TD"
Chad
"CL"
Chile
"CN"
China
"CX"
Christmas Island
"CC"
Cocos (Keeling) Islands
"CO"
Colombia
"KM"
Comoros
"CG"
Congo
"CD"
Congo (the Democratic Republic of the)
"CK"
Cook Islands
"CR"
Costa Rica
"CI"
Côte d'Ivoire
"HR"
Croatia
"CU"
Cuba
"CW"
Curaçao
"CY"
Cyprus
"CZ"
Czech Republic
"DK"
Denmark
"DJ"
Djibouti
"DM"
Dominica
"DO"
Dominican Republic
"EC"
Ecuador
"EG"
Egypt
"SV"
El Salvador
"GQ"
Equatorial Guinea
"ER"
Eritrea
"EE"
Estonia
"ET"
Ethiopia
"FK"
Falkland Islands [Malvinas]
"FO"
Faroe Islands
"FJ"
Fiji
"FI"
Finland
"FR"
France
"GF"
French Guiana
"PF"
French Polynesia
"TF"
French Southern Territories
"GA"
Gabon
"GM"
Gambia
"GE"
Georgia
"DE"
Germany
"GH"
Ghana
"GI"
Gibraltar
"GR"
Greece
"GL"
Greenland
"GD"
Grenada
"GP"
Guadeloupe
"GU"
Guam
"GT"
Guatemala
"GG"
Guernsey
"GN"
Guinea
"GW"
Guinea-Bissau
"GY"
Guyana
"HT"
Haiti
"HM"
Heard Island and McDonald Islands
"VA"
Holy See
"HN"
Honduras
"HK"
Hong Kong
"HU"
Hungary
"IS"
Iceland
"IN"
India
"ID"
Indonesia
"IR"
Iran
"IQ"
Iraq
"IE"
Ireland
"IM"
Isle of Man
"IL"
Israel
"IT"
Italy
"JM"
Jamaica
"JP"
Japan
"JE"
Jersey
"JO"
Jordan
"KZ"
Kazakhstan
"KE"
Kenya
"KI"
Kiribati
"KW"
Kuwait
"KG"
Kyrgyzstan
"LA"
Laos
"LV"
Latvia
"LB"
Lebanon
"LS"
Lesotho
"LR"
Liberia
"LY"
Libya
"LI"
Liechtenstein
"LT"
Lithuania
"LU"
Luxembourg
"MO"
Macao
"MK"
Macedonia
"MG"
Madagascar
"MW"
Malawi
"MY"
Malaysia
"MV"
Maldives
"ML"
Mali
"MT"
Malta
"MH"
Marshall Islands
"MQ"
Martinique
"MR"
Mauritania
"MU"
Mauritius
"YT"
Mayotte
"MX"
Mexico
"FM"
Micronesia (Federated States of)
"MD"
Moldova
"MC"
Monaco
"MN"
Mongolia
"ME"
Montenegro
"MS"
Montserrat
"MA"
Morocco
"MZ"
Mozambique
"MM"
Myanmar
"NA"
Namibia
"NR"
Nauru
"NP"
Nepal
"NL"
Netherlands
"NC"
New Caledonia
"NZ"
New Zealand
"NI"
Nicaragua
"NE"
Niger
"NG"
Nigeria
"NU"
Niue
"NF"
Norfolk Island
"KP"
North Korea
"MP"
Northern Mariana Islands
"NO"
Norway
"OM"
Oman
"PK"
Pakistan
"PW"
Palau
"PS"
Palestine, State of
"PA"
Panama
"PG"
Papua New Guinea
"PY"
Paraguay
"PE"
Peru
"PH"
Philippines
"PN"
Pitcairn
"PL"
Poland
"PT"
Portugal
"PR"
Puerto Rico
"QA"
Qatar
"RE"
Réunion
"RO"
Romania
"RU"
Russia
"RW"
Rwanda
"BL"
Saint Barthélemy
"SH"
Saint Helena, Ascension and Tristan da Cunha
"KN"
Saint Kitts and Nevis
"LC"
Saint Lucia
"MF"
Saint Martin (French part)
"PM"
Saint Pierre and Miquelon
"VC"
Saint Vincent and the Grenadines
"WS"
Samoa
"SM"
San Marino
"ST"
Sao Tome and Principe
"SA"
Saudi Arabia
"SN"
Senegal
"RS"
Serbia
"SC"
Seychelles
"SL"
Sierra Leone
"SG"
Singapore
"SX"
Sint Maarten (Dutch part)
"SK"
Slovakia
"SI"
Slovenia
"SB"
Solomon Islands
"SO"
Somalia
"ZA"
South Africa
"GS"
South Georgia and the South Sandwich Islands
"KR"
South Korea
"SS"
South Sudan
"ES"
Spain
"LK"
Sri Lanka
"SD"
Sudan
"SR"
Suriname
"SJ"
Svalbard and Jan Mayen
"SZ"
Swaziland
"SE"
Sweden
"CH"
Switzerland
"SY"
Syria
"TW"
Taiwan
"TJ"
Tajikistan
"TZ"
Tanzania
"TH"
Thailand
"TL"
Timor-Leste
"TG"
Togo
"TK"
Tokelau
"TO"
Tonga
"TT"
Trinidad and Tobago
"TN"
Tunisia
"TR"
Turkey
"TM"
Turkmenistan
"TC"
Turks and Caicos Islands
"TV"
Tuvalu
"UG"
Uganda
"UA"
Ukraine
"AE"
United Arab Emirates
"GB"
United Kingdom
"UM"
United States Minor Outlying Islands
"US"
United States of America
"UY"
Uruguay
"UZ"
Uzbekistan
"VU"
Vanuatu
"VE"
Venezuela
"VN"
Vietnam
"VG"
Virgin Islands (British)
"VI"
Virgin Islands (U.S.)
"WF"
Wallis and Futuna
"EH"
Western Sahara
"YE"
Yemen
"ZM"
Zambia
"ZW"
Zimbabwe
p_c_t_final_report STRING may be null (3.2.6 Does a final report exist?)
p_c_t_gcp_rules STRING may be null (3.2.5 Were the clinical tests made according to GCP guidelines)
p_c_t_period STRING may be null (3.2.3 period)
p_c_t_phase STRING max. 80 characters, may be null (3.2.2 Phase)
preexisting_clinical_tries STRING may be null (3.2 Are there already results of clinical trials for the tested drug?)
registered_in_countries STRING[] max. 2 characters (3.1 Registration in other states?) - choices:
"AF"
Afghanistan
"AX"
Åland Islands
"AL"
Albania
"DZ"
Algeria
"AS"
American Samoa
"AD"
Andorra
"AO"
Angola
"AI"
Anguilla
"AQ"
Antarctica
"AG"
Antigua and Barbuda
"AR"
Argentina
"AM"
Armenia
"AW"
Aruba
"AU"
Australia
"AT"
Austria
"AZ"
Azerbaijan
"BS"
Bahamas
"BH"
Bahrain
"BD"
Bangladesh
"BB"
Barbados
"BY"
Belarus
"BE"
Belgium
"BZ"
Belize
"BJ"
Benin
"BM"
Bermuda
"BT"
Bhutan
"BO"
Bolivia
"BQ"
Bonaire, Sint Eustatius and Saba
"BA"
Bosnia and Herzegovina
"BW"
Botswana
"BV"
Bouvet Island
"BR"
Brazil
"IO"
British Indian Ocean Territory
"BN"
Brunei
"BG"
Bulgaria
"BF"
Burkina Faso
"BI"
Burundi
"CV"
Cabo Verde
"KH"
Cambodia
"CM"
Cameroon
"CA"
Canada
"KY"
Cayman Islands
"CF"
Central African Republic
"TD"
Chad
"CL"
Chile
"CN"
China
"CX"
Christmas Island
"CC"
Cocos (Keeling) Islands
"CO"
Colombia
"KM"
Comoros
"CG"
Congo
"CD"
Congo (the Democratic Republic of the)
"CK"
Cook Islands
"CR"
Costa Rica
"CI"
Côte d'Ivoire
"HR"
Croatia
"CU"
Cuba
"CW"
Curaçao
"CY"
Cyprus
"CZ"
Czech Republic
"DK"
Denmark
"DJ"
Djibouti
"DM"
Dominica
"DO"
Dominican Republic
"EC"
Ecuador
"EG"
Egypt
"SV"
El Salvador
"GQ"
Equatorial Guinea
"ER"
Eritrea
"EE"
Estonia
"ET"
Ethiopia
"FK"
Falkland Islands [Malvinas]
"FO"
Faroe Islands
"FJ"
Fiji
"FI"
Finland
"FR"
France
"GF"
French Guiana
"PF"
French Polynesia
"TF"
French Southern Territories
"GA"
Gabon
"GM"
Gambia
"GE"
Georgia
"DE"
Germany
"GH"
Ghana
"GI"
Gibraltar
"GR"
Greece
"GL"
Greenland
"GD"
Grenada
"GP"
Guadeloupe
"GU"
Guam
"GT"
Guatemala
"GG"
Guernsey
"GN"
Guinea
"GW"
Guinea-Bissau
"GY"
Guyana
"HT"
Haiti
"HM"
Heard Island and McDonald Islands
"VA"
Holy See
"HN"
Honduras
"HK"
Hong Kong
"HU"
Hungary
"IS"
Iceland
"IN"
India
"ID"
Indonesia
"IR"
Iran
"IQ"
Iraq
"IE"
Ireland
"IM"
Isle of Man
"IL"
Israel
"IT"
Italy
"JM"
Jamaica
"JP"
Japan
"JE"
Jersey
"JO"
Jordan
"KZ"
Kazakhstan
"KE"
Kenya
"KI"
Kiribati
"KW"
Kuwait
"KG"
Kyrgyzstan
"LA"
Laos
"LV"
Latvia
"LB"
Lebanon
"LS"
Lesotho
"LR"
Liberia
"LY"
Libya
"LI"
Liechtenstein
"LT"
Lithuania
"LU"
Luxembourg
"MO"
Macao
"MK"
Macedonia
"MG"
Madagascar
"MW"
Malawi
"MY"
Malaysia
"MV"
Maldives
"ML"
Mali
"MT"
Malta
"MH"
Marshall Islands
"MQ"
Martinique
"MR"
Mauritania
"MU"
Mauritius
"YT"
Mayotte
"MX"
Mexico
"FM"
Micronesia (Federated States of)
"MD"
Moldova
"MC"
Monaco
"MN"
Mongolia
"ME"
Montenegro
"MS"
Montserrat
"MA"
Morocco
"MZ"
Mozambique
"MM"
Myanmar
"NA"
Namibia
"NR"
Nauru
"NP"
Nepal
"NL"
Netherlands
"NC"
New Caledonia
"NZ"
New Zealand
"NI"
Nicaragua
"NE"
Niger
"NG"
Nigeria
"NU"
Niue
"NF"
Norfolk Island
"KP"
North Korea
"MP"
Northern Mariana Islands
"NO"
Norway
"OM"
Oman
"PK"
Pakistan
"PW"
Palau
"PS"
Palestine, State of
"PA"
Panama
"PG"
Papua New Guinea
"PY"
Paraguay
"PE"
Peru
"PH"
Philippines
"PN"
Pitcairn
"PL"
Poland
"PT"
Portugal
"PR"
Puerto Rico
"QA"
Qatar
"RE"
Réunion
"RO"
Romania
"RU"
Russia
"RW"
Rwanda
"BL"
Saint Barthélemy
"SH"
Saint Helena, Ascension and Tristan da Cunha
"KN"
Saint Kitts and Nevis
"LC"
Saint Lucia
"MF"
Saint Martin (French part)
"PM"
Saint Pierre and Miquelon
"VC"
Saint Vincent and the Grenadines
"WS"
Samoa
"SM"
San Marino
"ST"
Sao Tome and Principe
"SA"
Saudi Arabia
"SN"
Senegal
"RS"
Serbia
"SC"
Seychelles
"SL"
Sierra Leone
"SG"
Singapore
"SX"
Sint Maarten (Dutch part)
"SK"
Slovakia
"SI"
Slovenia
"SB"
Solomon Islands
"SO"
Somalia
"ZA"
South Africa
"GS"
South Georgia and the South Sandwich Islands
"KR"
South Korea
"SS"
South Sudan
"ES"
Spain
"LK"
Sri Lanka
"SD"
Sudan
"SR"
Suriname
"SJ"
Svalbard and Jan Mayen
"SZ"
Swaziland
"SE"
Sweden
"CH"
Switzerland
"SY"
Syria
"TW"
Taiwan
"TJ"
Tajikistan
"TZ"
Tanzania
"TH"
Thailand
"TL"
Timor-Leste
"TG"
Togo
"TK"
Tokelau
"TO"
Tonga
"TT"
Trinidad and Tobago
"TN"
Tunisia
"TR"
Turkey
"TM"
Turkmenistan
"TC"
Turks and Caicos Islands
"TV"
Tuvalu
"UG"
Uganda
"UA"
Ukraine
"AE"
United Arab Emirates
"GB"
United Kingdom
"UM"
United States Minor Outlying Islands
"US"
United States of America
"UY"
Uruguay
"UZ"
Uzbekistan
"VU"
Vanuatu
"VE"
Venezuela
"VN"
Vietnam
"VG"
Virgin Islands (British)
"VI"
Virgin Islands (U.S.)
"WF"
Wallis and Futuna
"EH"
Western Sahara
"YE"
Yemen
"ZM"
Zambia
"ZW"
Zimbabwe