FDA "covered trial"
Croatian translation: ispitivanje pod nadzorom FDA (u pogledu financiranja)
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| 09:55 Sep 28, 2013 |
| English to Croatian translations [PRO] Medical - Medical (general) | |||||||
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|  Selected response from: Daryo United Kingdom Local time: 10:05 | ||||||
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| 4 +1 | ispitivanje pod nadzorom FDA (u pogledu financiranja) |
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| 3 -1 | Ispitivanje koje sponzorira/naručuje FDA |
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Answers
33 mins confidence: 
peer agreement (net): -1
peer agreement (net): -1| fda "covered trial" Ispitivanje koje sponzorira/naručuje FDA Explanation: ja bih tako |
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6 hrs confidence: peer agreement (net): +1
peer agreement (net): +1ispitivanje pod nadzorom FDA (u pogledu financiranja) Explanation: or the long variant "ispitivanje pod nadzorom FDA u pogledu obaveze objavljivanja podataka o financiranju" an "FDA covered trial" is a clinical trial which results would be later used to support an application to market a drug, and where the FDA requires disclosure of financial interest of all those involved in the clinical trial. The main point is to establish whether or not the trial is sponsored/financed by those who stand to gain from marketing the drug if it's later approved by the FDA. The FDA is not organising nor sponsoring the trial, only controlling who is financing the trial. The question was already asked few times: “In drug development, a covered clinical study refers to a clinical study, submitted to the Food and Drug Administration (FDA) as part of a marketing application (for example, as part of an NDA), about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study” “covered study” est en allemand traduit par “offenlegungspflichtige studie”, ce qui signifie : “étude soumise à l'obligation de publication des documents comptables” [http://www.proz.com/kudoz/english_to_french/medical:_pharmac...] Document published by the FDA: "Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators III. FINANCIAL DISCLOSURE REQUIREMENTS Under the applicable regulations, an applicant is required to submit to FDA a list of all clinical investigators who conducted covered clinical studies and to identify those who are full-time or part-time employees of the sponsor of each covered study (21 CFR § 54.4). For each clinical investigator who was not a full-time or part-time employee of a sponsor of the clinical study, the applicant must provide either a certification, using FORM FDA 3454, that none of the financial interests or arrangements described in 21 CFR § 54.4(a)(3) (see Section III.B. below) exists, or completely and accurately disclose, using FORM FDA 3455, the nature of those interests and arrangements to the agency and describe any steps taken to minimize the potential for bias resulting from those interests and arrangements (21 CFR § 54.4(a)). If the applicant acts with due diligence to obtain the required information but is unable to do so, the applicant may certify that it acted with due diligence but was unable to obtain the information and include the reason the information could not be obtained (21 CFR § 54.4). FDA generally expects that applicants will be able to provide this information. Under 21 CFR §§ 312.53(c), 812.20(b)(5) and 812.43(c), a sponsor is required to obtain clinical investigator financial information before allowing the clinical investigator to participate in a covered clinical study. Under 21 CFR § 54.4(b), each clinical investigator who is not a full-time or part-time employee of the sponsor of the covered clinical study is required to provide the sponsor with sufficient accurate financial information to allow for complete disclosure or certification and to update this information if any relevant changes occur during the study and for one year following its completion. page 23 G. COVERED CLINICAL STUDY G.1. Q: Disclosure of financial interests and arrangements is required only for covered clinical studies, specifically, those studies relied upon to provide support for the effectiveness of a product or in which a single investigator makes a significant contribution to the demonstration of safety (21 CFR §§ 54.2(e) and 54.3). An IND sponsor, acting much earlier, must inquire into investigator financial interests and arrangements before the ultimate role of a study in the application is determined (21 CFR § 312.53). How will the IND sponsor determine which studies will ultimately require certification/disclosure statements? A: The IND sponsor will need to consider the potential role of a particular study based on study size, design, and other considerations. Almost any controlled effectiveness study could, depending on outcome, become part of a marketing application, but other studies might be critical too, such as a pharmacodynamic study in a population subset or a bioequivalence study supporting a new dosage form. So, for many studies, it would be prudent to collect the information in the event that the study will ultimately require certification and disclosure statements. ...." [http://www.fda.gov/downloads/RegulatoryInformation/Guidances...] |
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