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2019年2月12日 (火)

「同意書」

神戸にお住まいの医学翻訳フリーランサーのみなさん、こんにちは。

Medical Translator NARITAです。

 

さて、イートモ対訳の見直しをしていると、いろいろ気付くことがあります。

今回は「同意書」をどう英訳するか。

イートモで検索すればすぐわかりますが、イートモにも不良対訳が多いので、念のため調べてみることにします。

 

思い浮かぶのは、

consent form

informed consent form

の2つ。

 

CROとか製薬会社とか、それぞれのホームページに用語集のようなものを出しているようです。

それらを参考にするのもいいですが、クライアントからの指定がなければ、役所のサイトを基準にするのがいいと思います。

「治験関係の用語はPMDAサイトに準拠しました」とコメントを記載すればばっちりです。

 

PMDA先生で調べてみます。

"consent form"の検索結果 約130 件

"informed consent form"の検索結果 約114 件

つまり、consent formのほとんどのケースにinformedがセットになっていると推察されます。

件数が多ければいいというわけではないけど、1つの指標にはなります。

個々の文書を実際に見てみると、実際にセットになっています。

よって、治験への参加同意の文脈では、イートモでも基本的に"informed consent form"を使うことにします。

 

"consent form"でイートモを検索した結果です。

84件がヒットしました。

今回は和文を提示していません。

                                                                                               
英文
A copy of any changes or renewals   of the informed consent form also must be sent promptly to the study monitor.
a copy of the IRB-approved informed   consent form and other adjunctive materials
A   parent or guardian of a minor patient must also read and initial each item   before signing the informed consent form.
A sample case report form (CRF) is provided in Appendix 1, while   Appendix 2 contains a sample informed consent   form.
Additional reference is made to the   above IND777, and to the model Informed Consent   Form for Study A sent to the regulatory authority   for review on May 1, 2017.
After having been informed that participation is voluntary and that   the participants may withdraw from the study at any time, without prejudice,   the patient must sign the IRB- and sponsor-approved informed consent form in the   presence of a witness.
After the informed consent form is read to   the subject and signed by the subject, the witness should also sign the consent form, attesting the subject   freely gave that informed consent.
After the patient has signed the informed   consent form to participate in the study, a   registration sheet will be completed and faxed or emailed to the sponsor for   approval of entry of the patient onto the study.
All concomitant therapies must be recorded throughout the study beginning with   signing of the informed consent form until the end-of-study visit.
Anticipated benefits of the study drug and anticipated disadvantage to the   subjects must be described in the informed   consent form and explained to the subjects prior   to enrollment in this study.
Any changes to the informed consent form suggested by   the investigator must be approved by the sponsor before submission to the   IRB, and a copy of the approved version must be provided to the sponsor's   monitor.
Any changes to the informed consent   form suggested by the investigator must be   approved by the sponsor before submission to the IRB/IEC.
Any updates to the informed consent form will be   provided to the subject.
Appendix 1 contains a copy of a sample informed consent form.
Before implementing this study, the   protocol, the informed consent form, and other information to subjects must be reviewed by a   properly constituted institutional review board.
Before study initiation, the Investigator must have approval from the   IRB/IEC for the protocol, informed consent form, subject recruitment materials, and any other written   information to be provided to subjects.
By signing this consent form, you agree to follow   your doctor's instructions, attend all study-related visits, and perform all   study specific assessments.
By signing this consent form, you give the Sponsor permission to use material obtained from   your blood sample for the research described above.
Company A has made the change to   the informed consent form for Study A, taking into account the available data.
During a subject's participation in the study, any updates to the informed consent form and any   updates to the written information will be provided to the subject.
Each subject   must sign the informed consent form after the nature of the study has been fully explained.
Entries in the Case Report Forms are verified   using subject files, informed consent forms signed by subjects, drug accountability forms, and original   recordings from automated instruments, X-ray films, laboratory notes, etc.
explanatory   materials and consent form used   for obtaining informed consent
For the conduct of the phase III clinical studies, specific   language will be included in the informed consent   form to address the potential for impairment of   fertility.
I will receive a signed copy of   this informed consent form.
If an amendment substantially alters the study design or   increases the potential risk to the subject, the informed   consent form must be revised and submitted to the   IRB/IEC via the head of the study site for review and approval/favorable   opinion.
If the original signed informed consent form will be   filed with the subject's source documents, a memo, describing that the   original informed consent form has been filed with the subject's source documents, should be   displayed in the Regulatory Binder.
If the subject had no prior medical history or current conditions   at the time of signing informed consent form, select “No” and leave the rest of the CRF blank.
If the subject is unable to read   the informed consent form, an impartial witness should be present during the entire   informed consent discussion.
If written informed consent was obtained, enter the date informed consent form was signed by   the guardian or subject.
If you decide that you do not want   to participate in this research, you may still participate in the clinical   study and receive the study drug if you have signed the informed consent form for the   clinical study and continue to qualify for the clinical study.
If you decide to participate, you will be   asked to sign this informed consent form.
In   a correspondence dated May 1, 2017, Company A accepted the regulatory   authority's recommendation and committed to submitting an updated version of   the model informed consent form   when it became available.
Informed consent form will be sent to the subject beforehand, but will not be filled   in until the screening visit.
Once you know about the study and   the tests that will be done, you will be asked to sign this consent form to join this study.
Patients who meet all of the inclusion criteria and none of the exclusion   criteria described below and who agree to voluntarily sign the informed consent form will be   considered “enrolled” into the study.
Preparation of the informed consent form must adhere   to GCP and to the ethical principles that have their origin in the   Declaration of Helsinki.
Prior to performance of any study-related activity, the informed consent form should be   signed and dated by the subject or his/her legally acceptable representative   and by the person who conducted the informed consent discussion.
Proposed   text for inclusion in the informed consent form is as follows: …
Samples collected for exploratory pharmacogenetic analysis will be   retained for up to 15 years, as indicated in the informed   consent form.
Signing   this consent form does not   take away all of your legal rights. You still have rights as a participant in   a study.
Subjects and legally acceptable   representatives must sign an informed consent form after the nature of the study has been fully explained and all   questions have been answered to the subject's satisfaction.
The "Track Changes"   mechanism in Microsoft Word should be used when making changes to the informed consent form.
The contract research organization (CRO) must   approve all informed consent forms used in the study prior to submission to the IRB.
The   date the first subject signs a study-specific informed   consent form will be defined as the start of the   study.
The document should include the date the subject signed the informed consent form and that a   signed copy was given to the subject.
The   impartial witness should sign and date the informed   consent form attesting that the information is   accurate.
The informed consent form and any other written information provided to the subject should   be revised whenever important new information becomes available that is   relevant to the subject’s consent.
The informed consent form must include a statement that the sponsor and regulatory   authorities have direct access to subject records.
The informed consent form must be dated   and signed prior to any screening procedures.
The informed consent form must have been approved by the sponsor and the investigator's   institutional review board.
The informed consent form should also   provide an explanation of the potential risk associated with QT interval   prolongation in language that can be understood by the patients.
The informed consent form should be updated or amended whenever new information becomes   available that may be relevant to the subject.
The informed consent form should   include all requirements according to local law.
The   institutional review board or ethics committee must review this protocol and   the informed consent form prior   to initiating this study.
The investigator making the explanation must date and sign or seal the informed consent form to make the   consent effective.
The investigator must keep a copy   of the signed informed consent form.
The investigator must obtain the Institutional Review Board's written approval   of the informed consent form and any other written information to be provided to the   subjects via the head of the study site, prior to the beginning of the study.
The investigator must provide the   subject or legally acceptable representative with a copy of the informed consent form and written   information about the study.
The investigator must provide the subject or legally acceptable representative   with the informed consent form and written information about the study in language that is   non-technical and easily understood.
The investigator must provide the   subject with a copy of the informed consent form and written information about the study in language that is   non-technical and easily understood.
The investigator must revise the informed consent   form whenever important new information becomes   available that is relevant to the subject's consent.
The investigator should allow time   necessary for the subject to inquire about the details of the study, then the   informed consent form   must be signed and dated by the subject and the person who conducted the   informed consent discussion.
The medical expert will assist in creating and reviewing all study-related   documents, including the sample informed consent   form and the investigator's brochure.
The protocol and the informed consent form were reviewed   and approved by the investigator's IRB before initiation of the study.
The protocol and the informed consent form will receive Institutional Review Board (IRB)/Independent   Ethics Committee (IEC) approval/favorable opinion prior to initiation of the   study.
The   purpose of this informed consent form is to give you information so that you can decide whether you   want to provide an additional blood sample(s) in conjunction with the   clinical study of Drug A in which you may participate.
The required topics to be included in the informed consent form are listed in   Appendix 1.
The   revised informed consent form   must be used to obtain consent from subjects currently enrolled in the study.
The sample informed consent form will adhere to the ethical principles that have their origin   in the Declaration of Helsinki.
The sponsor must have a copy of   written and dated approval from the Institutional Review Board for the   protocol, informed consent form, subject recruitment materials (e.g., advertisements), and any   other written information to be provided to subjects.
The sponsor will provide the investigator with an appropriate sample informed consent form which will   include all elements required by ICH, GCP, and regulatory requirements.
The study drug will not be   distributed to an investigator until the institutional review board (IRB) or   ethics committee has provided written approval of the study and informed consent form to the   investigator.
The subject agrees, when signing the informed   consent form, that they will not be provided with   the results from the research, nor will the results be available at any time.
The   subject must sign an informed consent form documenting this discussion.
The subjects will be asked to read and understand an informed consent form designed   specifically for the purpose of collecting a blood sample for genetic   research.
This   consent form tells you about   the study that you may wish to join.
This consent form may contain words that you do not understand.
This   informed consent form should   only be modified to the extent necessary to meet applicable legal   requirements.
This page is   used to collect all prior psoriasis therapies up to the point when the   subject signed the informed consent form.
Upon signing the informed consent form, the patient   is assigned the sequential number by the Investigator.
When the patient has signed the informed   consent form, the investigator or his/her staff   will telephone the Committee and provide the identifying information for the   patient.
You will be asked to sign a   separate consent form   for the extension study.
You will be asked to sign an informed consent form at screening.

ではでは。

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