FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data.
Bulgarian: Данните, произведени като пряко компютърно въвеждане, следва да бъдат идентифицирани с времето на въвеждане на данни от лицето/та, отговорно/и преките вписвания на данни.
English: Reference to OECD test guideline or other test guideline or method. 6.
Bulgarian: Справка с насоките за изпитване на ОИСР или с други насоки и методи за изпитване.
English: When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.
Bulgarian: Когато поради някаква причина образци на единици за изпитване или референтни единици се ликвидират преди крайния срок на изисквания период за съхранение, това следва да бъде обосновано и документирано.
English: Deadlines for transposition into national law (Article 6)
Bulgarian: Крайни срокове за въвеждане в националното законодателство (член 6 )
English: Quality assurance programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these principles of good laboratory practice.
Romanian: Programul de asigurare a calității reprezintă un sistem precis, incluzând personalul, care este independent de desfășurarea studiului și este menit să dea conducerii instalației de testare asigurarea că acesta respectă prezentele principii de bună practică de laborator.
English: When a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: 1.1.2(g), (i), (j) and (o).
French: Lorsqu'une ou plusieurs phases d'une étude se déroulent sur un site d'essai, la direction du site (si on en a désigné une) assumera les responsabilités décrites précédemment, à l'exception de celles qui figurent aux points 1.1.2 g), i), j) et o).
Portuguese: Quando uma ou várias fases de um estudo são realizadas num local de ensaio, a administração do local de ensaio (quando nomeada) assumirá as responsabilidades definidas supra, com as seguintes excepções: alíneas g), i), j) e o) do ponto 1.1.2.
Danish: Når en eller flere faser af et forsøg er udført på et forsøgssted, har forsøgsstedets ledelse (hvis en sådan er udpeget) ansvaret for ovennævnte opgaver med følgende undtagelser: 1.1.2, litra g), i), j) og o).
Czech: Jestliže se jedna nebo více etap studie provádějí ve zkušebním místě, přísluší výše vymezené povinnosti, s výjimkou bodu 1.1.2 písm. g), i), j) a o), vedení zkušebního místa (pokud bylo jmenováno).
Hungarian: Amennyiben az egyes vizsgálati szakaszokat egy vizsgálati helyszínen végzik, a helyszíni vizsgálatvezető (ha kijelölésre sor került) felelőssége a fent meghatározottakkal egyezik, a következő kivételekkel: 1.1.2(g), (i), (j) és (o) pont.
Romanian: Atunci când una sau mai multe faze ale unui studiu se derulează într-un loc de testare, conducerea locului de testare (în cazul în care a fost desemnată) are responsabilitățile menționate anterior, cu următoarele excepții: punctele 1.1.2 literele (g), (i), (j) și (o).
English: Assurance personnel in planning, scheduling, performing, documenting and reporting inspections.
Romanian: Repartizarea personalului responsabil cu asigurarea calității la planificarea, stabilirea calendarului, realizarea, documentarea și prezentarea rapoartelor controalelor.
English: Content of the study plan The study plan should contain, but not be limited to the following information:
Romanian: Conținutul planului studiului Planul de studiu trebuie să conțină informațiile enumerate în continuare, fără a se limita la acestea:
English: Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.)
French: l'identification de l'élément d'essai par un code ou par un nom (IUPAC, numéro du CAS, paramètres biologiques, etc.);
Italian: identificazione della sostanza in esame mediante codice o nome (IUPAC, numero CAS, parametri biologici, ecc.);
Portuguese: Identificação da substância para estudo através do seu código ou denominação (IUPAC, número CAS, parâmetros biológicos, etc.);
Danish: identifikation af teststoffet ved hjælp af kode eller navn (IUPAC; CAS-nummer, biologiske parametre osv.)
Czech: identifikace zkoušené položky pomocí kódu nebo názvu (IUPAC, číslo CAS, biologické parametry atd.);
Slovak: identifikácia testovanej položky znakom alebo názvom (IUPAC; číslo CAS; biologické parametre, atď.)
Polish: Identyfikację jednostki testowej według kodu lub nazwy (IUPAC, numer CAS, parametry biologiczne itd.)
Hungarian: A kísérleti anyag azonosítása kódszám vagy név alapján (IUPAC; CAS-szám, biológiai paraméterek stb.);
Slovenian: identifikacija preskušanca s šifro ali imenom (IUPAC, številka CAS, biološki parametri itd.)
Romanian: Identificarea elementului de testare printr-un cod sau nume (IUPAC, număr CAS, parametri biologici etc.)
Bulgarian: Идентификация на единицата за изпитване чрез код или наименование (IUPAC, номер по CAS, биологични параметри и др.).
Latvian: Testējamā vienuma identifikācija ar kodu vai nosaukumu (IUPAC, CAS numurs, bioloģiskie parametri, u.c.).
Lithuanian: Tiriamojo objekto įvardijimas kodu arba pavadinimu (IUPAC; CAS numeris, biologiniai parametrai ir t. t.)
Maltese: Identifikazzjoni ta’ l-oġġett tal-prova bil-kodiċi jew bl-isem (IUPAC, numru SAK, parametri bijoloġiċi, etċ.)
English: Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.
Polish: Urządzenia archiwizujące powinny zapewnić bezpieczne przechowywanie i udostępnianie planów badań, danych surowych, sprawozdań końcowych, próbek jednostek badań i okazów Projekt archiwum i warunki archiwizacji powinny chronić ich zawartość przed przedwczesnym zniszczeniem.
English: If any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study.
Polish: Jeżeli wystąpi jakakolwiek niezwykła śmiertelność lub ilość zachorowań, partia taka nie powinna być użyta podczas badań i, jeśli jest to odpowiednie, powinna zostać w sposób humanitarny zniszczona. w dniu rozpoczęcia eksperymentu, systemy testowe powinny być wolne od chorób i warunków, które mogłyby wpłynąć na cel lub przebieg badania.
English: A final report should be prepared for each study. In the case of short-term studies, a standardised final report accompanied by a study specific extension may be prepared.
Polish: Dla każdego badania powinno zostać przygotowane sprawozdanie końcowe. w przypadku badań krótkoterminowych może zostać przygotowane standardowe sprawozdanie końcowe, któremu towarzyszy szczególne rozszerzenie dla danych badań.
English: If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).ANNEX II
Slovak: Ak sa skončí činnosť testovacieho zariadenia alebo zariadenia zmluvne zabezpečujúceho archiváciu a neexistuje jeho právny nástupca, archivovaný materiál sa premiestni do archívov objednávateľa(ov) štúdie(í).
English: Terms concerning the non-clinical health and environmental safety study.
Czech: Pojmy týkající se neklinické studie bezpečnosti pro zdraví a pro životní prostředí.
English: Description of methods and materials used;
Czech: popis použitých metod a materiálů;
English: A summary of results;
Czech: souhrn výsledků;
English: All information and data required by the study plan;
Czech: všechny informace a údaje požadované v plánu studie;
English: A presentation of the results, including calculations and determinations of statistical significance;
Czech: přehled výsledků včetně výpočtů a stanovení statistické významnosti;
English: The study director should: (a) approve the study plan and any amendments to the study plan by dated signature;
Italian: approvare il programma di studio e qualsiasi eventuale modifica, firmandolo e datandolo;
English: Study personnel will have access to the study plan and appropriate standard operating procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents.
Italian: Il personale coinvolto nell'esecuzione dello studio deve avere accesso al programma di studio e alle POS applicabili alle mansioni attribuitegli ed è tenuto a seguire attentamente le istruzioni contenute in tali documenti.
English: verify that the study plan contains the information required for compliance with these principles of good laboratory practice. This verification should be documented;
Italian: verificare e quindi documentare che il programma di studio contenga le necessarie informazioni per renderlo conforme ai principi di BPL;
English: conduct inspections to determine if all studies are conducted in accordance with these principles of good laboratory practice. Inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed.
Italian: effettuare ispezioni per stabilire se tutti gli studi sono condotti in conformità dei principi di BPL, allo scopo inoltre di accertare che il programma di studio e le POS siano a disposizione del personale ed effettivamente applicati.
English: Storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. They should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.
Italian: I locali o le aree di conservazione delle sostanze in esame devono essere separati da quelli che contengono i sistemi di saggio ed essere adatti a preservarne identità, concentrazione, purezza e stabilità e a garantire il corretto immagazzinamento delle sostanze pericolose.
English: Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. Records of these activities should be maintained.
Italian: La strumentazione utilizzata per uno studio deve essere oggetto di ispezioni, pulizie e manutenzione regolari e calibrata in base alle POS. Tali operazioni devono essere sempre registrate.
English: Standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.
Italian: Devono essere disponibili POS relative alle seguenti categorie di attività, senza tuttavia escluderne altre (i dettagli indicati in ciascuna voce vanno intesi solo come esempi illustrativi):
English: For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the study director and verified for GLP compliance by quality assurance personnel as specified in section II2(20)(b).
Italian: Per ciascuno studio deve esistere un programma scritto, elaborato prima del suo avvio, approvato, datato e firmato dal direttore dello studio e verificato dal personale addetto all'assicurazione di qualità onde valutarne la conformità alle BPL [cfr. punto II.2.2.b)].
English: Dates (a) The date of approval of the study plan by signature of the study director.
Italian: Date: a) data di approvazione del programma mediante apposizione della firma del direttore dello studio.
English: Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study.
Italian: I campioni prelevati nel corso dello studio devono essere identificati onde preservarne l'origine e consentire di rintracciarli.
English: Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the study director.
Italian: Eventuali correzioni o aggiunte alla relazione finale devono avere forma di modifiche ufficiali, nelle quali è chiaramente specificato il motivo di tali correzioni o aggiunte e figurano la firma e la data apposte dal direttore dello studio.
English: Dates Experimental starting and completion dates.
Italian: Date: date di inizio e conclusione della sperimentazione.
English: They should: (a) maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule;
Slovenian: hraniti kopije vseh odobrenih načrtov študije in standardnih operativnih postopkov, ki so v uporabi v preskuševalnem laboratoriju, ter imeti dostop do najnovejše kopije glavnega razporeda;