Addendum template

Croatian translation: predložak dopune

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase: Addendum template
Croatian translation:predložak dopune
Entered by: V&E-Team

22:16 Sep 29, 2014
English to Croatian translations [PRO]
Medical - Medical (general) / legal medical letter
English term or phrase: Addendum template
Attached is an updated ICF template and Addendum template (if applicable) with proposed language for your reference.

ICF je Informed Consent Form

traži se izraz - Addendum template
V&E-Team
Croatia
Local time: 01:38
predložak dopune/dodatka (informiranom pristanku)
Explanation:
"Addendum" u pravnoj terminologiji predstavlja dopunu ugovoru (kao što je kolega naveo u svom odgovoru), tj. dokument kojim se menjaju uslovi ugovora (npr. okolnosti koje utiču na sprovođenje ugovora od dana potpisivanja ugovora).

Ovde mislim da je reč o predlošku dopune/dodatka informiranom pristanku jer ispitanici prvo potpisuju ICF (informirani pristanak) čime dobrovoljno izražavaju svoju spremnost da učestvuju u nekom kliničkom istraživanju/ispitivanju ali ako dođe do izmene nekog aspekta kliničkog ispitivanja ili pružanja nekih novih informacija koji mogu da utiču na odluku ispitanika o učestvovanju u istom, onda se ispitaniku dostavlja i taj dodatak/prilog koji mora da potpiše.

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...

ICF Addendum Template
Instructions:
Use this form to give currently enrolled subjects new information about the research. It may be used instead of re-consenting with the full informed consent form.

Summary of changes to the informed consent document
You are currently participating in the above named research study being conducted by << PI name>>. The consent form you previously signed told you that you would be informed of any significant new findings during the research study, such as changes in the risks or benefits of participation, new alternatives to participation, or changes in study procedures. The purpose of this consent addendum is to inform you of changes in the study. All other sections of the original consent form still apply. Please refer to it for any questions you might have.

The following are changes that have been made to this research study since you signed the original consent form...

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...

GUIDELINES FOR PREPARING AN ADDENDUM TO INFORMED CONSENT DOCUMENTS

The addendum consent should only be prepared for subjects who are currently taking part in a study:

1)When subjects need to be informed of any significant new findings developed during the course of participation that may have a bearing on their willingness to continue in the study.

2)When subjects need to be informed of specific changes..
Addendum Consent Template: Always use the current version of the Addendum Consent template.
Selected response from:

Maja Stojanović
Serbia
Local time: 01:38
Grading comment
hvala
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2predložak dopune/dodatka (informiranom pristanku)
Maja Stojanović
4predložak dopune ugovora
Ratko Rebic


Discussion entries: 4





  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
addendum template
predložak dopune ugovora


Explanation:
Procedura dopune Ugovora (Addendum) obuhvaća sljedeće korake:...
http://www.uzuvrh.hr/UserFiles/Upute i savjeti EU projekti(1...



--------------------------------------------------
Note added at 1 hr (2014-09-29 23:23:00 GMT)
--------------------------------------------------

Ili: Predložak dodatka ugovoru.

Ratko Rebic
Croatia
Local time: 01:38
Native speaker of: Native in CroatianCroatian
PRO pts in category: 68
Notes to answerer
Asker: hvala na sudjelovanju :)

Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
addendum template
predložak dopune/dodatka (informiranom pristanku)


Explanation:
"Addendum" u pravnoj terminologiji predstavlja dopunu ugovoru (kao što je kolega naveo u svom odgovoru), tj. dokument kojim se menjaju uslovi ugovora (npr. okolnosti koje utiču na sprovođenje ugovora od dana potpisivanja ugovora).

Ovde mislim da je reč o predlošku dopune/dodatka informiranom pristanku jer ispitanici prvo potpisuju ICF (informirani pristanak) čime dobrovoljno izražavaju svoju spremnost da učestvuju u nekom kliničkom istraživanju/ispitivanju ali ako dođe do izmene nekog aspekta kliničkog ispitivanja ili pružanja nekih novih informacija koji mogu da utiču na odluku ispitanika o učestvovanju u istom, onda se ispitaniku dostavlja i taj dodatak/prilog koji mora da potpiše.

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...

ICF Addendum Template
Instructions:
Use this form to give currently enrolled subjects new information about the research. It may be used instead of re-consenting with the full informed consent form.

Summary of changes to the informed consent document
You are currently participating in the above named research study being conducted by << PI name>>. The consent form you previously signed told you that you would be informed of any significant new findings during the research study, such as changes in the risks or benefits of participation, new alternatives to participation, or changes in study procedures. The purpose of this consent addendum is to inform you of changes in the study. All other sections of the original consent form still apply. Please refer to it for any questions you might have.

The following are changes that have been made to this research study since you signed the original consent form...

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...

GUIDELINES FOR PREPARING AN ADDENDUM TO INFORMED CONSENT DOCUMENTS

The addendum consent should only be prepared for subjects who are currently taking part in a study:

1)When subjects need to be informed of any significant new findings developed during the course of participation that may have a bearing on their willingness to continue in the study.

2)When subjects need to be informed of specific changes..
Addendum Consent Template: Always use the current version of the Addendum Consent template.

Maja Stojanović
Serbia
Local time: 01:38
Specializes in field
Native speaker of: Native in SerbianSerbian, Native in Serbo-CroatSerbo-Croat
PRO pts in category: 4
Grading comment
hvala

Peer comments on this answer (and responses from the answerer)
agree  Maja Čaprić
7 hrs
  -> Hvala!

agree  Ratko Rebic: Da, točnija opcija.
12 hrs
  -> Hvala :) Vaša opcija je svakako tačna, samo se u navedenom kontekstu traži drugo značenje.
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