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English to Croatian: segment from a clinical study protocol General field: Medical Detailed field: Medical (general)
Source text - English Reasons for Withdrawal or Termination
A subject may be discontinued from the study at any time if the subject, the Investigator, or the Sponsor feels that it is not in the subject’s best interest to continue. The following is a list of possible reasons for study treatment discontinuation:
• Screening Failure
• Subject withdrawal of consent
• Subject is not compliant with study procedures
• Adverse Event that in the opinion of the Investigator would be in the best interest of the subject to discontinue study participation • Protocol violation requiring discontinuation
• Lost to follow-up
• Sponsor request for early termination of study
• Subject death
All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. Reasonable attempts will be made by the Investigator to provide a reason for subject withdrawals. The reason for the subject’s withdrawal from the study will be specified in the subject’s source documents and the Case Report Form (CRF). If a subject is withdrawn from treatment due to an AE (adverse Event), the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized. The Investigator must make every effort to contact subjects who are lost to follow-up. Attempts to contact such subjects must be documented in the subject’s records (e.g., times and dates of attempted telephone contact, receipt for sending a registered letter, etc.).
Handling of Participant Withdrawals of Termination:
Although subjects may withdraw from the study at any time and for any reason, (or may be withdrawn at the Investigator’s discretion), subject withdrawal should be avoided as much as reasonably possible. In any case, appropriate follow-up for endpoints should be continued. Subjects who prematurely discontinue are not to be replaced. For subjects considered lost to follow-up, the CRF must be completed up to the last visit performed.
Premature Termination or Suspension of Study:
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the reason for study suspension or termination, will be provided by the suspending or terminating party to the Investigator, the Sponsor and the Institutional Review Board (IRB), as appropriate. If the study is prematurely terminated or suspended, the Investigator will promptly inform the IRB and will provide the reason(s) for the termination or suspension. Circumstances that may warrant termination or suspension include, but are not limited to:
• Determination of unexpected, significant, or unacceptable risk to participants
• Demonstration of efficacy that would warrant stopping
• Insufficient compliance to protocol requirements
• Data that are not sufficiently complete and/or evaluable
• Determination of futility
Study may resume once concerns about safety, protocol compliance, data quality are addressed and satisfy the Sponsor and/or the IRB.
Translation - Croatian Razlozi za opoziv ili raskid ugovora
Subjekt može prekinuti sudjelovanje u studiji u bilo kojem trenutku ako subjekt, istraživač ili sponzor smatraju da nastavak studije nije u njegovu najboljem interesu.
Ispod je popis mogućih uzroka prestanka liječenja:
• Neuspjeh tijekom procesa odabira
• Subjekt povlači pristanak
• Subjekt se ne slaže s procedurama studije
• Nepovoljni događaj zbog kojeg bi, prema mišljenju Istražitelja, u najboljem interesu subjekta bilo da subjekt prekine sudjelovanje u studiji
• Kršenje protokola koje zahtijeva prekid
• Subjekti koji se nakon tretmana ne odazivaju na dodatne preglede
• Zahtjev sponzora za prijevremeni prekid studije
• Smrt subjekta
Svi subjekti slobodno mogu odustati od sudjelovanja u bilo kojem trenutku, iz bilo kojeg razloga, određenog ili neodređenog, i bez predrasuda. Istražitelj će nastojati navesti razumne razloge povlačenja subjekta iz studije. Razlog za povlačenje subjekta iz studije bit će naveden u izvornim dokumentima subjekta i obrascu izvješća slučaja (CRF). Ako je subjekt povučen iz procesa liječenja zbog AE (nepovoljnog događaja), Istraživač će ga liječiti sve dok neodgovarajući parametar ili simptom nestane ili stabilizira. Istražitelj mora učiniti sve kako bi uspostavio kontakt sa subjektima koji se ne odazivaju na kontrolne preglede. Pokušaji kontaktiranja takvih subjekata moraju biti dokumentirani u kartonima subjekata (kao što su vrijeme i datum telefonskog kontakta, potvrda o slanju preporučenog pisma, itd.).
Obrada povlačenja sudionika pri raskidu ugovora:
Iako se subjekti mogu povući iz studije u bilo kojem trenutku i iz bilo kojeg razloga (ili se mogu povući prema nahođenju istraživača), povlačenje subjekta treba izbjegavati koliko god je razumno moguće. U svakom slučaju, potrebno je nastaviti odgovarajuće promatranje prema definiranim krajnjim točkama. Subjekti koji prerano obustave liječenje ne mogu se zamijeniti. Za subjekte koji se ne odazivaju na dodatne preglede, CFR mora biti popunjen do posljednjeg ostvarenog posjeta.
Prerani prekid ili obustava studije:
Ova studija može biti privremeno obustavljena ili prerano prekinuta ako postoje dovoljno razumni razlozi. Pisana obavijest koja dokumentira razlog obustave ili prekida studije bit će dostavljena istražitelju, sponzoru i institucionalnom Nadzornom odboru (IRB), od strane tijela koje vrši obustavu ili prekid studije, shodno okolnostima. Ako je studija prerano prekinuta ili obustavljena, istražitelj će odmah obavijestiti IRB i odrediti uzrok (uzroke) obustave ili prekida. Okolnosti koje mogu zahtijevati prekid ili suspenziju uključuju, ali nisu ograničene na:
• Utvrđivanje neočekivanog, značajnog ili neprihvatljivog rizika za sudionike
• Dokazivanje učinkovitosti koja bi garantirala zaustavljanje
• Nedovoljna usklađenost sa zahtjevima protokola
• Nepotpuni i/ili nemjerljivi podaci
• Utvrđivanje beskorisnosti
Studija se može nastaviti nakon što se riješe sigurnosni problemi, usklađenost s protokolom, kvaliteta podataka na zadovoljstvo sponzora i/ili IRB.
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Experience
Years of experience: 4. Registered at ProZ.com: May 2021.
English to Croatian (Science degrees (B.S. and M.S.) from the US universities) English to Croatian (university level science instructor)
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SDL Trados, Smartcat
Bio
I specialize in the field of pharmaceutical, medical, and life science translation. This encompasses the translation of clinical trials, regulatory approvals, and a diverse range of documents related to R&D, drug production, pharmacovigilance, medical devices, marketing, and basic research. A triple degree in Life-sciences (B.S. degree in Chemistry, M.S. in Microbiology and PhD in Pharmaceutical biotechnology), two of which earned from reputable US universities, and 20+ years of working experience in Pharma and Academia as a research scientist and teacher, provide me with a strong knowledge base in this subject area. Having worked in the Pharma industry, I possess insider knowledge of the Industry, in-depth understanding of the processes, terminology, and the underlying legislation. This rare blend of expertise and extensive international experience makes me your ideal and trusted partner in solving your language needs. Your success is my job. Let’s do it!
Keywords: Croatian, English to Croatian, Croatian to English, medical, pharmaceutical, clinical, clinical trials, regulatory approval, training material, marketing/sales. See more.Croatian, English to Croatian, Croatian to English, medical, pharmaceutical, clinical, clinical trials, regulatory approval, training material, marketing/sales, research, science, Life science. See less.
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