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ICON Clinical Research Checklist and Translation

Before you get started on translation of the file, always check the source file first for any issues that may affect the quality of your work and alert the Project Coordinator if there are issues. Always contact the Project Coordinator if: a) The scanned source file is of poor quality; causing many illegibles b) the file is not the language pair indicated by the Project Coordinator in the New Job Info c) The estimated word count of the file is much larger than given. If there are no problems at all with the file, we can get started with the translation

ALL FOREIGN TEXT MUST BE TRANSLATED, UNLESS OTHERWISE INSTRUCTED

1. DATES AND TIMES:


All dates should be in EU format following the conventions of the target language For example November 5, 2008 becomes 05.11.2008 in German All times should be in 24 hr format following the conventions of the target language; For example 12:08; 00:19 Please note: Do not convert height and weight measurements i.e., if the source is in Fahrenheit/inches, do not convert to Celsius/centimetres. 2. REFERENCING: Foreign text: Please reference foreign text by writing [please see source for LANGUAGE]; this includes, but is not exclusive to: Foreign stamps, chunks of foreign text, lists of abbreviations that are the same in the target language, etc. Please note: If there is foreign text mixed with English and its exclusion would cause the translation to lose meaning or not be clear, please retype the foreign. For text that is in foreign but also has dates/times: you may reference the foreign text but you must reproduce the date and time using EU format following the conventions of the target language. For example, [please see source for German text] 19.03.1985 22:00 Uhr Redacted parts: Redacted refers to words, sentences, sections, etc. that are blacked out or scratched out in the source. Please put [redacted] in the same place it would appear in the source. For example, Patient: [redacted] Please note: When you come across text where the patients confidential info (names/address/phone number) is not redacted in the source, please replace it with [please see source], because this is most likely a mistake by the client; we must make every effort to retain the patients confidentiality. Doctors names and patient detail needed for reference by the client such as age, hometown, birthplace should not be redacted if it is not redacted in the source. Illegible text (this includes both handwritten and typewritten text): Please do your best to decipher all handwriting. However, if you cannot read the text, you may put [illegible] for each word. For example, the [illegible] medication was [illegible], OR, for entire sentences that you cannot decipher, you may write: [illegible sentence]. If the handwriting is particularly bad or it is a poor source copy, please be extra careful during translation and put anything you are unsure about in hard brackets [ ], especially for messy handwritten files. For example: [sedation] is required. If an entire paragraph is not legible, you may reference accordingly with [illegible paragraph]. Please note: if text is cut off, it should be referenced as [text cut off]. Diagrams, Graphs, Illustrations, etc.: Please reference these accordingly with [please see source for diagram], [please see source for graph], [please see source for illustration]. If applicable, you may also put [please see source for graph and numbers], etc.

ICON style sheet version 7 February 2012

Please note: If there is any foreign text, make sure that it is translated. This is especially pertinent to tables, therefore please check all tables and graphs carefully for any text they might contain. Fax headers: Headers and footers created by fax machines are not to be referenced or reproduced (please see HEADERS/FOOTERS section for translation instructions concerning headers/footers). Units, values and numbers in charts and tables: If they would be exactly the same in English, they do not need to be translated. Instead please put [please see source for units and values in LANGUAGE]. With the exception of lab values: please include lab numbers in the translations. Please note: Any text in the charts and tables that is not the target language must be translated! Logos, emblems and signatures: Simply put [logo], [emblem] or [signature] in the same place where they appear in the source file. Miscellaneous: If you spot an error in the source language (an acronym was written incorrectly, a number is clearly incorrect, a word is missing, etc.), translate according to the source and include [sic] so that the client/reader is aware there might be a problem or some misleading information. If you are certain that you know the correct word that should be there you can put [sic: corrected translation]. For example, the source is talking about surgery being performed on the left foot, but suddenly there is a mention of the right foot that seems completely out of context. Follow the source: right [sic: left] foot. US addresses: Confirm with Sales on each job whether the US address needs to be translated or left in English with the translation in brackets for the corresponding language.

3. ACRONYMS: If acronyms are the same in English and the foreign language, you do not need to
change the acronym. However, if acronyms differ, please write only the target acronym (since these files will be read by people in the medical field, this information is common knowledge). If there is an acronym that is not common, or does not exist in your target language, please expand and translate the acronym. For example, RCA (right coronary artery) and LAD (left anterior descending) are very common acronyms that have different equivalents in foreign languages. If you are unsure of what the acronym stands for, or if multiple options are possible, please notify the PM immediately so that we can ask client for clarification. For German and Croatian, abbreviations of titles like Dr. med. or Prof. Dr. should be left untranslated as they carry different meanings than their equivalents in English. Further, any other LPs with this term should have the accuracy of this translation double checked before delivering to Sales.

4. HEADERS/FOOTERS: Fax page information should not be retyped: do not translate fax cover
sheet (if applicable) or any fax information at the top of the page doctors contact information, fax information, printer information, etc. that is irrelevant to the main body of medical text and could be referenced instead of retyped (this, particularly, refers to text that was not originally a part of the document, but was produced by the printer or fax machine). Letterheads, however, must be translated as this information is related to the office where the text is coming from.

5. FORMATTING: Please format the translation so it reflects the source as closely as possible, and
is still easy to follow. For example, punctuation (all text that is in CAPITAL LETTERS in the

ICON style sheet version 7 February 2012

source needs to be in CAPITAL LETTERS in the translation), page count, column, placement of text, use of bold/italics/underlining, etc. Please see further information on formatting under NECESSARY PROOFREADING STEPS.

6. HANDWRITTEN TEXT: All handwritten text must be indicated in italics and referenced. You
should italicize any and all translated text that is handwritten in the source. If the file is more than 40% handwritten, at the top of the first page, please put [handwritten text is indicated in italics]. Otherwise you must put [hw:] next to the handwritten text. Please do not put [handwritten:] more than three times on a page unless the text is dispersed. For example you should put [hw:] This is the English translation for the patient information of patient no. 12345.

7. TEXT IN MARGINS: Translate any text that appears along the left and right margins of files
either by formatting the file so it appears in the translation as it does in the source or by indicating that text at the bottom of the page: [left margin:] or [right margin:] and typing the translation next to it. Text that is in margins but unrelated to the actual file (mainly because of poor scanning) should be referenced as [unrelated handwritten text in left/right margin]. For example, if the corner of page 3 appears on page 4 by accident due to poor photocopying.

8. SPACING: Do not add spaces before or after a slash (example: and/or).


NECESSARY PROOFREADING STEPS 1. Print the source and translation file(s).

Check the Translated English text for each of the following categories of objective errors, making all necessary changes on the printed documents: Specifics: - typos - punctuation - misspelling - proper names - numbers - abbreviations and acronyms - consistency in diacritics and accent marks - type and direction of quotation marks; curly quotes should be used for quotes and apostrophes - Check that there are no double-spaces after punctuation. There should absolutely be no double-spaces between words and numbers; they may only be used to aid in formatting. - run a spell and grammar check using UK English - ensure that no text is mistakenly repeated - check that page numbers and Bates number match (if applicable) - Make sure the file is formatted to mirror the source page for page. For example, your translated text should not have 13 translated pages if the source file only has 12. Exceptions can be made if decreasing font size to fit the pages would affect the legibility of the file. If this is impossible to achieve, please contact the PM. Please check below for details on formatting. Content: - compare sentence by sentence to the source - check the translation for mistranslations/correct interpretation of terms - ensure consistency between terms Missing text: - compare sentence by sentence to the source, to make sure there is no missing text

ICON style sheet version 7 February 2012

Format according to the source: - Make sure the paper size is set to Letter, not A4. - Pagination (pages must be separated by page breaks, NOT by hard returns) - Paragraph breaks - Font, size, bolding, underline, italics, bullets - Capitalization Implement edits into the electronic document. Afterwards, check that all your edits have been made correctly and that no new errors have been introduced. Deliver the document in the format requested by the Project Coordinator, clean, with no track changes or comments (unless requested by client). SINCE EVERY FILE IS DIFFERENT, OR IF THERE IS SOMETHING YOU ARE NOT SURE OF, PLEASE ALWAYS CONTACT THE PROJECT COORDINATOR FOR QUESTIONS OR IF YOU FORSEE A DELAY IN DELIVERY.

ICON style sheet version 7 February 2012

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