Clinical Trial Network

Validated Patient Documents and Translations

Patients information and consent documents (English)

METREPAIR Appendix 1AB - ICF Final Version 1.0 dated 07 Feb 2017 
METREPAIR Appendix 1CD - ICF BNPsubstudy Final Version 1.0 dated 07 Feb 2017 
METREPAIR Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 dated 07 Feb 2017

Specific ICF version to be used in the United Kingdom

METREPAIR & FRAILTY App. 1AB – PIS ICF v 2.3 (UK ONLY)

Translations

Study documents translation are available in the following languages:

Arabic (Israel) - Bulgarian - Bosnian - Croatian - Dutch (Belgium) - Dutch (Netherlands)French (Belgium)French (France) - HebrewItalian - German (Austria) - German (Germany) - Greek - Maltese - Macedonian - Polish - Portuguese - Romanian - Russian - Serbian - Slovenian - Spanish - Swedish - Turkish

Translations must be done according to the Guidance, and be documented in the  form provided here below:

MET-REPAIR Study translation guidelines
Form to documents translation process 

Albanian (Albania)
METREPAIR Appendix 1AB - ICF  v1.0 07 Feb 2017 - Albania v1.0 validated 31AUG2018
METREPAIR Appendix 2 - Questionnaire v1.0 07 Feb 2017 Albania v1.0 validated 31AUG2018

Albanian (Kosovo)

METREPAIR Appendix 1AB - ICF  v1.0 07 Feb 2017 - Kosovo v1.0 validated 31AUG2018
METREPAIR Appendix 2 - Questionnaire v1.0 07 Feb 2017 Kosovo v1.0 validated 31AUG2018

Arabic (Israel) METREPAIR Appendix 1AB - ICF v 1.0 07 Feb 2017 - HEBREW v1.0 validated 7JUL2017
METREPAIR Appendix 2 Questionnaire v1.0 07 Feb2017 HEBREW v1.0 validated 7JUL 2017

Bulgarian

METREPAIR Appendix 1AB - ICF Final Version 1.0 dated 07 Feb 2017 - BULGARIAN- validated 11 July

METREPAIR Appendix 1CD - ICF BNPsubstudy Final Version 1.0 dated 07 Feb 2017 - BULGARIAN- validated 11 July

METREPAIR Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 dated 07 Feb 2017 - BULGARIAN- validated 11 July

METREPAIR Appendix 2 - Questionnaire Final Version 1.0 dated 07Feb 2017 - BULGARIAN- validated 11 July

Dutch (Belgium)

METREPAIR Appendix 1AB Dutch version for Belgium v1.0 validated 28 Nov 2017

METREPAIR Appendix 1CD Dutch version for Belgium v1.0 validated 28 Nov 2017
METREPAIR Appendix 2 Questionnaire Dutch version for Belgium v1.0 validated 28 Nov 2017

METREPAIR Appendix 1AB Dutch version for Belgium v1.1 9 02 2018 validated 07MAR17


French (Belgium)

METREPAIR Appendix 1AB French version for Belgium v1.0 validated 28 Nov 2017

METREPAIR Appendix 1CD French version for Belgium v1.0  validated 28 Nov 2017

METREPAIR Appendix 2 Questionnaire French version for Belgium v1.0  validated 28 Nov 2017

METREPAIR Appendix 1AB French version for Belgium v1.1 9 02 2018 validated 7MAR2018

French (France)

MET-REPAIR ANNEXE 1AB Feuille d'Information Version 1.0 validated 24 Nov 2017
MET-REPAIR ANNEXE 1CD Feuille d'Information Etude BNP Version 1.0 validated 24 Nov 2017
MET-REPAIR ANNEXE 1EF Feuille d'Information Version BNP Version 1.0 validated 24 Nov 2017MET-REPAIR ANNEXE 2 Questionnaire French for France Version 1.0 validated 24 Nov 2017

Hebrew

METREPAIR Appendix 1AB - ICF v 1.0 07 Feb 2017 - HEBREW v1.0 validated 7JUL2017

METREPAIR Appendix 2 Questionnaire v1.0 07 Feb2017 HEBREW v1.0 validated 7JUL 2017

Italian

METREPAIR Protocollo dello Studio - Versione Finale 1.0 ITALIAN validated 19 MAY17
METREPAIR Appendice 1A - Foglio informativo per il paziente Versione 1.0 - Versione Finale 1.0 ITALIAN validated 19 MAY17
METREPAIR Appendice 1B  - Modulo di consenso per il pazienteVersione Finale 1.0 ITALIAN validated 19 MAY17
METREPAIR Appendice 1C Sottostudio - Flogio informativo - Versione Finale 1.0 ITALIAN validated 19 MAY17
METREPAIR Appendice 1D Sottostudio - NTproBNP Versione Finale 1.0 ITALIAN validated 19 MAY17
METREPAIR Appendice 1E Sottostudio - NTproBNP- Versione Finale 1.0 ITALIAN validated 19 MAY17
METREPAIR Appendice 2 - Questionario Versione - Versione Finale 1.0 ITALIAN validated 19 MAY17

German (Germany)

METREPAIR Appendix 2 - Questionnaire FinalVersion1.0 07 Feb 2017_German for Germany validated

German (Austria)

MET-REPAIR Appendix 1AB patientInneninformation und einwilligungserklarung_v1.3 10Jul2018

METREPAIR Appendix 2 - Questionnaire FinalVersion1.0 07 Feb 2017_German for Austria validated 01DEC17

Greek

METREPAIR Appendix 1AB - ICF Final Version 1.0 dated 07 Feb 2017 GREEK validated 20SEP17

METREPAIR Appendix 1CD - ICF BNPsubstudy Final Version 1.0 dated 07 Feb 2017 GREEK validated 20SEP17

METREPAIR Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 07Feb17 Greek validated 21SEP17

METREPAIR Appendix 2 - Questionnaire Final Version 1.0 dated 07Feb 20.17 GREEK validated 20SEP17

Maltese

MET-REPAIR Appendici 1A Fuljett ta Informazzjoni ghall-pazjenti Versjoni Finali 1.1 - MALTESE validated 28JUN2018

MET-REPAIR Appendici 1B Formola tal-Kunsens, Versjoni 1.0 -MALTESE validated 28JUN2018

MET-REPAIR Appendici 2 Kwestjonarju Verżjoni 1.0 - MALTESE validated 02NOV2017

Macedonian

MET-REPAIR 1А Додаток - Appendix 1A Study Information sheet for Patients Macedonian version v1.0 validated 6FEB2018

MET-REPAIR 1Б Додаток - Appendix1B Macedonian version v1.0 validated 6FEB2018

MET-REPAIR Додаток 2 - Прашалник  -  Appendix 2 Questionnaire Macedonian version v1.0 validated 6Feb2018


Polish

METREPAIR Appendix 2 Questionnaire Final Version 10 dated 07Feb 2017
METREPAIR Appendix 1CD ICF BNPsubstudy Final Version 10 dated 07 Feb polish
METREPAIR Appendix 1EF ICF BNPsubstudystandalone Final Version 10 polish
METREPAIR Appendix 1AB ICF Final Version 10 dated 07 Feb 2017 Polish

Portuguese 

METREPAIR Appendix 1AB - ICF Final Version 1.0 dated 07 Feb 2017 PORTUGUESE validated 02NOV2017

METREPAIR Appendix 1CD - ICF BNPsubstudy Final Version 1.0 dated 07 Feb 2017 PORTUGUESE validated 02NOV2017

METREPAIR Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 07Feb17 PORTUGUESE validated 02NOV2017

METREPAIR Appendix 2 - Questionnaire Final Version 1.0 dated 07Feb 2017 PORTUGUESE validated 02NOV2017


Romanian

METREPAIR Appendix 2 Questionnaire Final Version 10 dated 07Feb 2017 Romanian
METREPAIR Appendix 1CD ICF BNPsubstudy Final Version 10 dated 07 Feb 
METREPAIR Appendix 1EF ICF BNPsubstudystandalone Final Version 10 
METREPAIR Appendix 1AB ICF Final Version 10 dated 07 Feb 2017 
METREPAIR Appendix 6  Final Version 10 dated 07Feb 2017 
METREPAIR Appendix 4 Final Version 10 dated 07Feb 2017 
METREPAIR Appendix 3  Final Version 10 dated 07Feb 2017 

Russian

METREPAIR перевод Appendix 1AB - ICF Final Version 1.0 dated 07 Feb 2017 – Russian - Validated 21 AUG 2017

METREPAIR перевод Appendix 1CD - ICF BNPsubstudy Final Version 1.0 dated 07 Feb 2017 – Russian - Validated 21 AUG 2017

METREPAIR перевод  Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 dated 07 Feb 2017 – Russian - Validated 21 AUG 2017

METREPAIR перевод Appendix 2 - Questionnaire Final Version 1.0 dated 07 Feb 2017 – Russian - Validated 21 AUG 2017

Serbian

METREPAIR DODATAK 1AB - Finalna Verzja 1.0 07 Feb SERBIAN validated 27JUL2017

METREPAIR DODATAK 1CD -  BNP podstudija Finalna Verzija 1.0 07 Feb SERBIAN validated 27JUL2017

METREPAIR DODATAK IEF - BNP  1.0 07 Feb SERBIAN validated 27 Jul 2017

METREPAIR DODATAK 2 - Upitnik Finalna Verzija 1.0 07 Feb SERBIAN validated 27 Jul 2017

Slovenian

METREPAIR Appendix 1AB - ICF Final Version 1.0 07FEB2017 SLOVENIAN validated 21SEP17

METREPAIR Appendix 1CD - ICF BNPsubstudy Final Version 1.0 SLOVENIAN v1.0 validated 21SEP17

METREPAIR Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 07 Feb 2017 SLOVENIAN v1.0 validated 21SEP17

METREPAIR Appendix 2 - Questionnaire Final Version 1.0 07FEB2017 SLOVENIAN v1.0 validated on 21SEP17

Spanish

METREPAIR Appendix 1AB - ICF Final Version 1.0 dated 07 Feb 2017 – Spanish -Validated 27 Jul 2017

METREPAIR Appendix 1CD - ICF BNPsubstudy Final Version 1.0 dated 07 Feb 2017 – Spanish -Validated 27 Jul 2017

METREPAIR Appendix 1EF - ICF BNPsubstudy_stand_alone Final Version 1.0 dated 07 Feb 2017 – Spanish -Validated 27 Jul 2017

METREPAIR Appendix 2 - Questionnaire Final Version 1.0 dated 07 Feb 2017 – Spanish -Validated 27 Jul 2017


Swedish

METREPAIR Appendix 1A - Information Sheet Version 1.0 SWEDISH validated 02NOV2017

METREPAIR Appendix 2 -   Questionnaire v1.0 07 Feb 2017 SWEDISH v1.0 validated 06OCT2017

Turkish

METREPAIR Ek 2-Anket v1.0 -TURKISH v1.0 validated 26JUL2017
METREPAIR Ek.1AB - ICF  v1.0 07 Feb 2017 -TURKISH v1.0 validated 26JUL20...
METREPAIR Ek.1CD - ICF  v1.0 07 Feb 2017 -TURKISH v1.0 validated 26JUL20...
METREPAIR Ek.1EF - ICF  v1.0 07 Feb 2017 -TURKISH v1.0 validated 26JUL20...