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Member since Jul '14
Working languages:
English to Spanish Spanish (monolingual) English (monolingual)
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Apr 9 (posted viaProZ.com): “Currently working on medical translation, revision and QA for clinical research and regulatory content (EN>ES).”...more, + 1 other entry »
Freelance translator and/or interpreter, Verified member
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Services
Translation, Editing/proofreading, AI + Human review (MT post-editing)
English to Spanish: ICF General field: Medical Detailed field: Medical (general)
Source text - English A placebo is a “dummy drug” and does not contain active medication, i.e., it won’t contain lebrikizumab; therefore, it does not provide a treatment benefit itself. A placebo group is an important part of a clinical study. It is used to try and make sure that any treatment effects that are seen are caused by the study medication and nothing else, since a comparison can be made at the end between patients that received lebrikizumab and those that received placebo.
After 52 weeks, you will enter the active treatment extension. This period may last for up to another 52 weeks. During this period, you will be guaranteed to receive lebrikizumab because no patients will be given placebo. If you were in Groups 1 or 2 during the placebo-controlled period, you will continue to receive the same medication in the active treatment extension period.
Translation - Spanish El placebo es una “medicación de simulación” y no contiene medicamento activo, es decir, no contiene lebrikizumab; por lo tanto, no brinda ningún beneficio de tratamiento en sí mismo. El grupo tratado con placebo constituye una parte importante de un estudio clínico. Se utiliza para intentar y asegurarse de que los efectos del tratamiento observados se deben al medicamento del estudio y nada más, dado que puede hacerse una comparación al final entre los pacientes que recibieron lebrikizumab y los que recibieron placebo.
Después de 52 semanas, ingresará al período de extensión del tratamiento activo. Este período puede durar hasta otras 52 semanas. Durante este período, se le garantiza que recibirá lebrikizumab porque ningún paciente recibirá placebo. Si pertenece a los grupos 1 o 2 durante el período controlado por placebo, continuará recibiendo el mismo medicamento en el período de extensión del tratamiento activo.
English to Spanish: Protocolo General field: Medical
Source text - English The investigator may in an emergency determine the identity of the vaccination by contacting the IWRS. While the responsibility to break the vaccination code in emergency situations resides solely with the investigator, it is recommended that the investigator contact the sponsor or its designee if possible, to discuss the particular situation before breaking the blind. Telephone contact with the sponsor or its designee will be available 24 hours per day, 7 days per week. In the event the blind is broken, the sponsor must be informed as soon as possible. The date, time, and reason for the unblinding must be documented by the IWRS, in the appropriate section of the eCRF, and in the source document. The documentation received from the IWRS indicating the code break must be retained with the participant’s source documents in a secure manner. The investigator is advised not to reveal the study vaccine assignment to the study site personnel or sponsor personnel/sponsor representative.
Translation - Spanish En caso de emergencia, el investigador puede determinar la identidad de la vacuna a través del IWRS. Si bien la responsabilidad de descifrar el código de vacunación en situaciones de emergencia reside únicamente en el investigador, si es posible se recomienda que el investigador se comunique con el patrocinador o la persona designada para examinar la situación particular antes de realizar el desenmascaramiento. Se podrá contactar por teléfono con el patrocinador o con su representante las 24 horas del día, los 7 días de la semana. En el caso de que se produzca un desenmascaramiento, habrá que informar al patrocinador lo antes posible. Deberá documentarse la fecha, la hora y el motivo del desenmascaramiento en el IWRS, en la sección correspondiente del CRDe y en el documento original. La documentación recibida del IWRS que indica que se ha descifrado un código se conservará con los documentos originales del participante de manera segura. Se aconseja al investigador que no revele la asignación de la vacuna del estudio al personal del centro del estudio ni al personal del patrocinador/representante del patrocinador.
English to Spanish: Contract General field: Law/Patents Detailed field: Medical (general)
Source text - English Reporting Obligations. Principal Investigator acknowledges that various laws, statutes, regulations, directives, and/or industry requirements (collectively, “Reporting Laws”) require certain companies in the pharmaceutical/healthcare industry to disclose and report information regarding payments made and agreements entered into with healthcare professionals or other individuals and entities carrying out activities in certain countries. Accordingly, where such Reporting Laws are applicable, Principal Investigator acknowledges and agrees that information, including but not limited to: (i) name, address, qualifications and medical specialties, registration number; (ii) information regarding the Agreement; and (iii) information concerning all payments or benefits (in cash or in kind) made to Principal Investigator under the Agreement may be disclosed by CRO to Sponsor and/or to the relevant responsible authority for publication of such information publicly in accordance with the relevant Reporting Laws.
Translation - Spanish Obligaciones de Información. El Investigador Principal reconoce que diversas leyes, estatutos, regulaciones, directivas y/o requisitos del sector (colectivamente, “Legislación de notificación”) requieren que determinadas compañías de la industria farmacéutica/atención médica divulguen y notifiquen la información relacionada con los pagos realizados y los acuerdos formalizados con profesionales de la salud u otros individuos y entidades que lleven a cabo actividades en determinados países. En consecuencia, cuando dicha Legislación de notificación sea aplicable, el Investigador Principal reconoce y acepta que la información, que incluye a modo de ejemplo: (i) nombre, dirección, calificaciones y especialidades médicas, número de registro; (ii) información relacionada con el Contrato; e (iii) información relacionada con todos los pagos o beneficios (en efectivo o en especie) realizados al Investigador Principal en virtud del Contrato puede ser divulgada por la CRO al Patrocinador y/o a la autoridad responsable relevante para la publicación de dicha información de acuerdo con la Legislación de notificación relevante.
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Translation education
Bachelor's degree - Universidad del Salvador
Experience
Years of experience: 33. Registered at ProZ.com: Jul 2014. Became a member: Jul 2014.
Credentials
English to Spanish (Universidad del Salvador, Facultad de Filosofía, Historia y Letras, verified)
English into Spanish translator and proofreader with over 30 years of experience, specialized in Life Sciences and Clinical Research: protocols, informed consent forms, investigator's brochures, package inserts, patient-facing materials, scales and questionnaires, adverse event reports, CRFs, and regulatory and ethics committee documents. Also experienced in legal and corporate documents. Sworn translator and court-appointed expert translator in Buenos Aires. Active ATA member; member of Tremédica and the Buenos Aires Translators Association (CTPBA). Tools: Trados, memoQ, Wordfast, Wordbee. Services: translation, proofreading and MTPE. Available for new projects; feel free to contact me or request my CV.
Member since Jul '14
Expertise 