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Translation, Copywriting, Editing/proofreading
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Sample translations submitted: 1
Polish to English: Zawiadomienie o wycofaniu badania na terenie Polski/Notification of the clinical trial withdrawal in Poland
Source text - Polish Szanowni Panstwo
W imieniu Sponsora chcielibysmy poinformowac o wycofaniu ww. badania klinicznego z Polski.
Decyzja o nierozpoczynaniu badania X na terenie Polski jest wynikiem korespondencji miedzy Sponsorem a Urzedem Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow Biobojczych, ktora dotyczyla wskazania do prowadzenia terapii dozylnej lekiem Y, jako kryterium wlaczenia dla wszystkich pacjentow. Zgodnie ze stanowiskiem Urzedu, pacjent pediatryczny uczestniczacy w badaniu klinicznym jest szczegolnie wrazliwym podmiotem i wymaga spelnienia warunku odniesienia korzysci bezposredniej z udzialu w badaniu. Jednak zgodnie z Protokolem badania, do badania kwalifikowani sa pacjenci niewymagajacy leczenia dozylnego. W opinii Urzedu budzi to powazne watpliwosci etyczne, gdyz podanie leku dozylnie u dziecka jest procedura inwazyjna i powinny istniec dla niej wyrazne wskazania, a nie jedynie brak przeciwskazan.
Dlatego Sponsor postanowil nie aktualizowac Protokolu, poniewaz doprowadziloby to do znacznej zmiany projektu badania dla Polski w porownaniu z innymi krajami uczestniczacymi. Ponadto, przejscie do badania dlugoterminowego A jest opcja dla kwalifikujacych sie pacjentow przechodzacych z badania B. Aktualizacja Protokolu w taki sposob, aby do badania kwalifikowali sie pacjenci z wyraznymi wskazaniami do leczenia dozylnego, rowniez wplynelaby na badanie A, w ktorym lek Y w podaniu dozylnym nie jest produktem badanym.
Mamy nadzieje, ze postawione tu informacje sa dostateczne, jednak w razie pytan prosimy o kontakt z osoba wyznaczona ponizej.
Translation - English Dear Sir/Madam,
On behalf of the Sponsor, we would like to inform you about the Sponsor’s decision to withdraw the above mentioned clinical trial in Poland.
The decision not to initiate the study X in Poland is the result of correspondence between the Sponsor and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, concerning intravenous therapy with the drug Y, as the main inclusion criteria for all patients. According to the Registration Office a paediatric patient participating in the clinical trial is a vulnerable subject, hence his or her participation in the study should warrant him or her receiving a direct benefit from the study. However, it is stipulated in the Protocol that patients who do not require intravenous treatment are qualified for the study. In Office’s opinion this raises serious ethical questions, because administering the drug intravenously to a child is an invasive procedure protected by clear indications and not the lack of contraindications.
Consequently, the Sponsor decided not to update the Protocol, as this would have significantly deviated from the study design in Poland in comparison to the other participating countries and introduced a biased component. Of note is the fact that both an option for eligible patients from study B to roll-over to the long-term study A and the revision of Protocol Amendment to include patients with clear indications for iv administration are in conflict, since together they both significantly affect the long-term study A, in which intravenous injection of the drug Y is not its IP.
We trust that the information provided above is adequate, however if you have any questions please do not hesitate to contact the person appointed below.
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Translation education
PhD - Neuroscience
Experience
Years of experience: 29. Registered at ProZ.com: Aug 2018.
I grew up in Poland and lived in Canada for over 20 years where I completed my education (B.Sc. Genetics; PhD in Neuroscience). For over 10 years I have worked as a professional both in academia and industry. I am fluent in scientific, medical and clinical terminology hence can deliver professional translation services in PL-->EN format. My preferred fields of work (PL-->EN) are: general medicine, health care, pharmacy, general science, immunology, genetics, neuroscience, genetic engineering, stem cell research, gene therapies. My preferred fields of work (EN-->PL) are: general texts, articles, biographies, private correspondence, nutrition, health-related topics, healing, consciousness, new-age topics. Currently I focus on freelancing jobs as a medical writer and a translator/linguist (my preferred language pairing is PL-->EN).
Keywords: English, Polish, general medicine, health care, pharmaceutical, clinical, general science, clinical trials