Reasons for rejection (R4R) definitions in translations To change this title, go to Notes Master Reasons for rejection (R4R) definitions in translations 11/14/2018 Laura Ferrario Global Subject Matter Expert for Translations AD Site Management, Regulatory & Start Up EMEA in collaboration with RRDonneley and TransPerfect V1.0_ 21Jan2016 _ FINAL

Introduction Reasons for rejections categories: True Translation Errors (TTEs): Duplications (Additions) & Deletions Mistranslations Inappropriate Terminology Formatting Issues Grammar Mistakes Stylistic Preferences Local Requirements Issue not caused by vendor

Reasons for rejection: definitions Type of error Category Definition Examples Duplication (Addition) / Deletion TTEs Duplication (Addition)/Deletion: source text information (words or portion of sentence) has been omitted from the target text or added to the target text that was not part of the source. This includes names/numbers, or any source content that needs to be replicated verbatim (hyperlinks, drug/product names,company names, dosage, financial data, contact info, etc.). Correct Translation: “The study will be conducted in 6 countries (France, Italy, Germany, Spain, Canada and Australia) in approximately 36 different institutions or sites and approximately 600 subjects may participate.« Duplication (Addition): Australia) in approximately 36 different institutions or sites and approximately 1600 subjects may participate. Deletion (Omission): The study will be conducted in 6 countries (France, Italy, Germany, Spain and Australia) in approximately 36 different institutions or sites and approximately 600 subjects may participate. (Canada missing)

Type of error Definition Examples Category Mistranslations TTEs Mistranslation of any words defined as an incorrect translation where the meaning of a source-language text by means of an equivalent target-language text is totally lost and/or the accuracy of the translation, i.e., "word by word and line by line”, or of any paraphrasis is missed. Example (1) Correct Translation: “You do not have to decide today whether or not you will participate in the research.” Mistranslation: “You must not decide today whether to be in the research.” Example (2) “In this study, half of the patients will be assigned to receive 5 mg linagliptin daily” Mistranslation (1): “In this study, half of the patients will be assigned to receive 5 mg linagliptin weekly” Mistranslation (2): “In this study, half of the patients will be assigned to receive 5 g linagliptin weekly”

Type of error Definition Examples Category Inappropriate terminology Use this category for inappropriate use (or non-use) of the pre-agreed glossaries/style guides TTEs Incorrect technical terms which may significantly compromise the overall meaning from a linguistic, textual, cultural and technical perspective (e.g. non-stylistic may lead to legal, safety, health, or financial consequences.) Incorrect technical term pertaining to the specific field of expertise Inconsistency with client validated glossary/style guide Inconsistent terminology within the translated document Example (1) Correct Translation: nutritional disease Incorrect technical terminology: nutritional condition Example (2) Correct Translation: alcohol abuse Incorrect technical terminology: alcohol addicted Example (3): According to approved terminology for ICFs, the word ’research’ and “study” cannot be used interchangeably in the target even if they are both recorded in the source and more specifically the term “research” should always be replaced by “study” Inappropriate use of pre-agreed glossary: if in the translated document both words (‘research’ and ‘study’) are used interchangeably Example (4): Inconsistent terminology within the translated document: both words (“patient” and “subject”) are used interchangeably in a 2-steps fully reviewed translated documents OR the vendor does not flag that the term “research” used in the amended text (e.g. track-changes) based on the current glossary does not reflect the term “study” used in previously translated and validated text when 2-steps full review of the amended document is requested. PLEASE NOTE: In an amendment request for an ICF with only partial review required, the terms “subject” and “patient” are used interchangeably in the target. The TSP validated glossary mandates to only used the term “patient”, but the term is translated with “subject” in the portion of text outside the update. Even if this is still an example of inconsistent terminology and inappropriate use of the pre-agreed glossary, this cannot be attributed to TSP. At the contrary it falls under the category “Issue not caused by vendor” – slide 9.

Type of error Definition Examples Category Formatting issues TTEs Formatting issues: errors relating to when source formatting of the word or pdf document was not followed correctly PLEASE NOTE: issues introduced within the source fall under the category “issue not caused by vendor” Examples of formatting issues may include: Table of Content (TOC), broken hyperlinks, page numbering, bad margins or font size and type not consistent with source due to OCR, unless otherwise requested or specified by the style guide

Type of error Definition Examples Category Grammar Mistakes TTEs Grammar mistakes includes errors (generally multiple errors within the same document) pertaining to spelling, grammar, punctuation, numbering, sentence structure or other errors that fundamentally impact on the overall quality of the document. Example: you are being asked to take part in a research studiesy. Before you decide to participate in this study, it is important that you understand why the research are is being done and what it will involve.

Type of error Category Definition Examples Local Requirements Stylistic preferences Category to be used when an alternative target language is more appropriate (vs the target language provided by TSP) as per requirements from Ethics Committee, Regulatory Authority or Sponsors. The requirement does not affect the overall meaning and/or medical/clinical appropriateness of the translation, however the reviewer, based on in-depth knowledge of the subject and requirements from the Ethics Committee, Regulatory Authority or Sponsors, deems appropriate to provide alternative terms or text not previously listed in the shared glossaries. The reviewer may propose to amend the target language by using paraphrasis in order to enhance the meaning of the text or add clarity. When appropriate/applicable such proposal should be documented in the shared glossary/style guide. Translation provided: Once you have decided that you want to take part, you must sign and date the informed consent form. You will be given a copy of the completed form to keep, and the original will stay at the study centre. Local Requirement: Once you have decided that you want to take part, you should sign and date the informed consent form. You will be given a copy of the completed form to keep, and the original will stay at the study centre. (reason:both matching the source but the second being less prescriptive) You have been invited to take part in this study because you are affected by type 2 diabetes mellitus You have been invited to take part in this study because you have type 2 diabetes mellitus (reason: both matching the source but the second being more neutral)

Type of error Category Definition Examples Issue not caused by vendor n/a Quintiles made errors in the document name or in the file and they require the vendor to fix them although not originating by the vendor Example (1): change of a requirement in labels occurring after the translation is requested Example (2): adjustments to address source errors after the translation is requested (could apply to translation or formatting) Example (3): illegible text returned with more clarification Example (4): change to approved study titles after delivery Example (5): unanswered responses to queries/comments that were posed before the deliverable