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hoja de certificación

English translation: certification page

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16:11 Feb 3, 2009
Spanish to English translations [PRO]
Medical (general) / Clinical Trials
Spanish term or phrase: hoja de certificación
This is the page signed by the primary investigator of the clinical trial:
____________________________________________________

HOJA DE CERTIFICACIÓN

Certifico que la información contenida en este Cuaderno de Recogida de Datos es un registro completo y exacto de los datos correspondientes a este paciente, que el estudio se realizó de acuerdo con lo estipulado en el protocolo, con la legislación española vigente sobre realización de ensayos clínicos con medicamentos en humanos, con las recomendaciones de la CEE sobre la Buena Práctica Clínica (procedimientos normalizados de trabajo), con los principios éticos de la Declaración de Helsinki (revisión de Hong Kong 1989) y se obtuvo el consentimiento informado del paciente o del tutor legal.

El Investigador Principal


Firma:……………………… Fecha:………………………….

____________________________________________________

I think the term I want is:

PROTOCOL SIGNATURE PAGE

But can anyone confirm this or, if I'm wrong, tell me what the correct terminology would be? I'm completely unfamiliar with the subject and have never really done medical translation before. Thanks.
ganzinblau
Spain
Local time: 07:10
English translation:certification page
Explanation:
Straightforward. 2,780 references. No point in getting fancy.

ANIMAL USE PROTOCOL
Co-Investigators: Complete and attach IACUC “investigator” certification page for additional faculty involved with your protocol. Name(s): ...
www.jmu.edu/sponsprog/iacuc/form_animal_use_protocol.doc

Application for an Amendment to an IACUC Approved Animal-Use Protocol ... However this certification page must be printed out, signed and submitted as a ...
vpr.utsa.edu/files/oric/iacuc/Amendment_form.doc

CERTIFICATION PAGE. Principal Investigator:. Project Title: ... all personnel who work with animals under this protocol have received appropriate training ...
www.ric.edu/.../Rhode Island College Institutional Animal

Dec 8, 2008 ... complete the tutorial, print out the certification page and send it to the ... The protocol application is scientifically sound and has ...
or.ucr.edu/home/Forms/RI/UCR%20HRRB%20Protocol.doc

cover page; instructions for application submission and protocol approvals ... mentor certification page; human subjects research form, as applicable, ...
www.dent.unc.edu/research/student/ddsfellowshipapp.doc



--------------------------------------------------
Note added at 1 day5 hrs (2009-02-04 21:18:49 GMT)
--------------------------------------------------

Emma,

My understanding is that Case Report Form is the standard and that Data Collection Form is an alternate synonym. Note the following citations. I didn' track down the references, but they suggest that the terms mean the same thing, although, again, CRF is standard:

Investigational Drug Case Report Form (Data Collection Form) Template ... Subject Enrollment Form (Data must be relevant to the study protocol) ...
www.ahc.umn.edu/ocr/prod/groups/ahc/@pub/@ahc/documents/ass...

Data Collection Tool in Clinical Trials: Case Report Form
A case report form (CRF) is a data collection tool used in clinical trials to support investigators. and coordinators in capturing all protocol-required ...
www.scian.com/news/sciannews91b.pdf

... and the data collection instrument should be attached to the protocol. Data collection instruments are usually a paper Case Report Form, screen-prints ... An Electronic Data Collection (EDC) System is a computer based or a computer ...
www.rpd.queens.org/rss.php
Selected response from:

Muriel Vasconcellos
United States
Local time: 22:10
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +2certification page
Muriel Vasconcellos
4 +1sign-off page
Michael Powers (PhD)
4protocol signature page
Rosa Paredes
3Investigator's statement
Emma Goldsmith
Summary of reference entries provided
liz askew

Discussion entries: 1





  

Answers


12 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
sign-off page


Explanation:
Results 1 - 10 of about 2,520 for research "sign off page". (0.31 seconds)
Search Results

1. [DOC]
DEPARTMENT OF PEDIATRICS STRONG CHILDREN’S RESEARCH CENTER
File Format: Microsoft Word - View as HTML
Clinical Research Proposal Sign-off and request for scientific review Form, Project ID : ..... Proposal Sign-Off Page v.20060525 NLF.
www.urmc.rochester.edu/pediatrics/research/PCRO/PCROSignoff... - Similar pages -
2. [PDF]
BIO 100 LAB SIGN OFF PAGE - UNIT 8 Name
File Format: PDF/Adobe Acrobat - View as HTML
keep this sign off page, along with your completed lab worksheets, as proof of your lab ... ______ Unit 8, Step 4 (Human Genetic Disease Research) ...
dtc.pima.edu/blc/100/100su07/008/100Unit08labsheets.pdf - Similar pages -
3. [PDF]
BIO 183 LAB SIGN OFF PAGE — UNIT 14
File Format: PDF/Adobe Acrobat - View as HTML
this sign off page, along with your completed lab worksheets, ... from a year-long oceanographic research cruise in the North Atlantic Ocean. Your ...
dtc.pima.edu/blc/183/14_183/183unit14labWS.pdf - Similar pages -
4. [PDF]
Research Department
File Format: PDF/Adobe Acrobat - View as HTML
and research team, providing a blank CRF and discusses what data is to be collected ... corrections and sign off page. 5. The STH Investigator completes a ...
www.sth-research.group.shef.ac.uk/documents/sops/sop_a124_c... - Similar pages -
5. [PDF]
Department Head/ Chair User Manual and Reference
File Format: PDF/Adobe Acrobat - View as HTML
signature on a research protocol. Below is an example of the email you will .... at your Submissions to Sign Off page. You will enter your username and ...
flpublichealthethics.net/index.php/eng/content/download/232/1394/file/Department%20Head%20User%20Manual_July%202005.pdf - Similar pages -
6.
PI UR Sign-off, page 7
Office of Research and Project Administration ... remunerative and other activities related to their teaching, research and administrative responsibilities. ...
www.rochester.edu/ORPA/resource/page7.html - 16k - Cached - Similar pages -
7.
Supervisor not wanting to sign off-Page 2 - Newbies/Appraiser ...
To ellaborate a little more: I did inspections, market/data research, approaches to value, reconciliation. Sometimes w/his assistance, sometimes w/out. ...
appraisersforum.com/showthread.php?p=1255404 - 72k - Cached - Similar pages -
8.
CIMIT: Grants Frequently Asked Questions (FAQs)
1. What is the "institutional sign off page?" It is the official sheet from your research administration office indicating that your proposal is approved by ...
www.cimit.org/grants-faqs.html - 80k - Cached - Similar pages -
9.
Search Results | Council for Nature Conservation and the Countryside
... 0.9 Page 2 of 203 RMA Systems Sign Off Page Name Organisation /Position Signature ... Research Paper [insert ref number] Research and Library Services ...
www.cnccni.gov.uk/search.lsim?sr=20&qt=uploads&ha=0&mt=1&nh... - 18k - Cached - Similar pages -
10.
We got the final sign off - Page 2 - Adoption.com Forums
5/06-8/06 Research 9/15 Signed with Agency!!!! The paperchase begins! 9/25 a princess is born 10/2 Homestudy Application and Police fingerprints ...
forums.adoption.com/guatemala-adoption/330291-we-got-final-sign-off-2.html - 93k - Cached - Similar pages -


Mike :)

Michael Powers (PhD)
United States
Local time: 01:10
Native speaker of: Native in EnglishEnglish
PRO pts in category: 274

Peer comments on this answer (and responses from the answerer)
agree  Rafael Bordabehere
7 mins
  -> Thank you, rafaelB - Mike :)
Login to enter a peer comment (or grade)

18 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
protocol signature page


Explanation:
I think this is the term you are looking for. Suerte.



    Reference: http://www.wright.edu/rsp/Animals/RESSIGPG.doc
    Reference: http://www.chelationwatch.org/research/tact/Regulatory_Requi...
Rosa Paredes
Canada
Local time: 22:10
Works in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 48
Login to enter a peer comment (or grade)

9 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
Investigator's statement


Explanation:
.

--------------------------------------------------
Note added at 14 mins (2009-02-03 16:25:59 GMT)
--------------------------------------------------

http://hugr.huji.ac.il/Files/CRF/hugr_schizophrenia.pdf
INVESTIGATOR'S STATEMENT CONCERNING DATA VERIFICATION. I have verified the data entered in the Case Report Form and have determined that it is


By the way, "Cuaderno de Recogida de Datos" is Case Report Form.

--------------------------------------------------
Note added at 46 mins (2009-02-03 16:57:53 GMT)
--------------------------------------------------

Hi Liz,
You had me worried for a moment. I've been translating CRD as CRF for years. I've just been looking it up and still feel that it is correct:

http://en.wikipedia.org/wiki/Case_Report_Form
A Case Report Form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

http://www.proz.com/kudoz/spanish_to_english/medical:_pharma...

I've looked up "data collection sheet" and the examples I have found refer to shorter questionnaire-type forms that don't include the very detailed information that is entered in a CRF.
However, I'd be happy to change to your suggestion if you can provide me with more evidence.

--------------------------------------------------
Note added at 4 hrs (2009-02-03 21:11:00 GMT)
--------------------------------------------------

Further notes on "Cuaderno de Recogida de Datos":

This is all fascinating, Liz, and is taking up far too much time when I should be getting some work finished. However...


With regard to "Cuaderno de recoleccion de Datos" I have found 7 hits in Google, which suggests that it is not an option.

"formulario de registro clínico individual" has 89 hits, mainly from Argentina (as is the answerer of the Proz entry on this subject).

"formulario de Reporte Clínico Individual" has one hit, which is your ref from concaic.org (also Argentina)

I think I will continue to use "Cuaderno de Recogida de Datos" (1170 hits) and I'll put forward 2 more references to support my cause!

http://www.uv.es/~docmed/documed/documed/591.html
Diseño de protocolos de un estudio clínico: las denominadas "case report forms" o cuadernos de recogida de datos

http://www.fabis.org/html/archivos/cursos/ecap/Durant_el_EC....
(See p.3 of this pdf)




Emma Goldsmith
Spain
Local time: 07:10
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 855

Peer comments on this answer (and responses from the answerer)
neutral  liz askew: Hi, I though CRD = data collection sheet?//Rather late in the day, but yes it is CRF!! I have just had this in a translation I have had to do:-) Sorry for the confusion:-) [mine]
26 mins
  -> Please see my new note.
Login to enter a peer comment (or grade)

4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
certification page


Explanation:
Straightforward. 2,780 references. No point in getting fancy.

ANIMAL USE PROTOCOL
Co-Investigators: Complete and attach IACUC “investigator” certification page for additional faculty involved with your protocol. Name(s): ...
www.jmu.edu/sponsprog/iacuc/form_animal_use_protocol.doc

Application for an Amendment to an IACUC Approved Animal-Use Protocol ... However this certification page must be printed out, signed and submitted as a ...
vpr.utsa.edu/files/oric/iacuc/Amendment_form.doc

CERTIFICATION PAGE. Principal Investigator:. Project Title: ... all personnel who work with animals under this protocol have received appropriate training ...
www.ric.edu/.../Rhode Island College Institutional Animal

Dec 8, 2008 ... complete the tutorial, print out the certification page and send it to the ... The protocol application is scientifically sound and has ...
or.ucr.edu/home/Forms/RI/UCR%20HRRB%20Protocol.doc

cover page; instructions for application submission and protocol approvals ... mentor certification page; human subjects research form, as applicable, ...
www.dent.unc.edu/research/student/ddsfellowshipapp.doc



--------------------------------------------------
Note added at 1 day5 hrs (2009-02-04 21:18:49 GMT)
--------------------------------------------------

Emma,

My understanding is that Case Report Form is the standard and that Data Collection Form is an alternate synonym. Note the following citations. I didn' track down the references, but they suggest that the terms mean the same thing, although, again, CRF is standard:

Investigational Drug Case Report Form (Data Collection Form) Template ... Subject Enrollment Form (Data must be relevant to the study protocol) ...
www.ahc.umn.edu/ocr/prod/groups/ahc/@pub/@ahc/documents/ass...

Data Collection Tool in Clinical Trials: Case Report Form
A case report form (CRF) is a data collection tool used in clinical trials to support investigators. and coordinators in capturing all protocol-required ...
www.scian.com/news/sciannews91b.pdf

... and the data collection instrument should be attached to the protocol. Data collection instruments are usually a paper Case Report Form, screen-prints ... An Electronic Data Collection (EDC) System is a computer based or a computer ...
www.rpd.queens.org/rss.php

Muriel Vasconcellos
United States
Local time: 22:10
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 1306
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Suzanne Deliscar
21 mins
  -> Thanks, Suzanne!

agree  Emma Goldsmith: As a principal investigator yourself, please could you confirm how you translate "Cuaderno de Recogida de Datos" in view of the confusion below. thanks very much . Thanks for the clarification Muriel
22 hrs
  -> Thanks, Emma! See my comments in the body of my answer.
Login to enter a peer comment (or grade)




Reference comments


3 hrs
Reference

Reference information:
Emma

I don't do translations for clinical trials, although I am currently awaiting one for the first time, so I am no expert here.

However, there are plenty of refs for "cuaderno de recolección de datos" here:

http://www.google.co.uk/search?hl=en&as_q=CRD cuaderno de re...

Now, I do not know whether this translates as CRF...?

--------------------------------------------------
Note added at 3 hrs (2009-02-03 19:35:55 GMT)
--------------------------------------------------

have you seen this Proz entry?

http://209.85.229.132/search?q=cache:WkDGNFanXw8J:www.proz.c...



--------------------------------------------------
Note added at 3 hrs (2009-02-03 19:36:56 GMT)
--------------------------------------------------

AND

[PDF]
Administración Nacional de Medicamentos, Alimentos y Tecnología ...
- [ Translate this page ]
File Format: PDF/Adobe Acrobat - View as HTML
formulario de registro clínico individual (FRCI) para verificar que el dato fuente, fue. reportado en forma precisa y completa. ...
www.femeba.org.ar/fundacion/quienessomos/Novedades/guia_ins... - Similar pages

see what you think.....

--------------------------------------------------
Note added at 3 hrs (2009-02-03 19:38:58 GMT)
--------------------------------------------------

::: ConCAIC :::
- [ Translate this page ]
Se debe tener cuidado de completar este formulario con precisión para asegurar .... de los datos del Formulario de Reporte Clínico Individual (FRCI/CRF) y ...
concaic.org/ - 4k - Cached - Similar pages

liz askew
United Kingdom
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 3841
Login to enter a peer comment (or grade)




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