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43 Cards in this Set
- Front
- Back
For the UK only study, instead of CSR, we quoted for ___. They use the info to implement a rigorous interventional study so they won't need a __ __ __.
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Manuscript.
Clinical study report |
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For 55 study, our assumptions were based on PRA standard process and will not include ___of a __system, no dispatch to___, and ___TMF returned at __ __ ___only.
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Duplication
eTMF Phlexglobal paper end of study |
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One question for 55 study was if we would remove the eTMF training in both bids as well (assuming this was for training on ___TMF)? She said _____
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UCBs
no not ready to do this yet |
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A major advantage to conducting the trials in Belgium is that start-up timeline for sites here is ___than in many countries; sites can be activated in as early as __months.
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Shorter
three |
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The Country Start-up Specialist (CSS), who oversees a ___of specialised staff that is assembled at a ___level for each project.
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Team
Country |
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The team that the CSS oversees includes these 4 positions. (SS, C, I, CA)
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Submission Specialist -
CRA IHCRAs Contract Associate |
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The submission specialists submits to ___ (unless submitted ___ in ____) and ___
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MoH
Centrally, English ECs |
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What role does the CRA perform in start up? Performs ____
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PSSVs
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The Contract Associate negotiates __ and ___ with sites
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Language
budget |
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The CSS leads all aspects of the clinical start-up activities at the country level, in order to achieve successful ___of sites (defined as ready to ___with ___ on site)
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Activation
Recruit Drug |
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After__ ___, the CSS and team (except___) move off the project team. All sites then move under the ownership of the ___ ___(from ___onwards) and the IHCRA who provides the ___of contact with the sites.
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site activations
IHCRA monitoring CRA SIV continuity |
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Focusing ownership and leadership at a ___-level, where there are specific ___and __, allows PRA to provide a core team of individuals with a high level of __who regularly specialise in ___activities, and allows the PRA team to build __within each country
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Country
Differences, nuances Expertise start-up relationships |
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Description of PV Responsibilities transferred from UCB to PRA for Taiwan study includes ___ management and __ ___.
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Safety
Expedited reporting |
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PV - For Taiwan study, on behalf of UCB, PRA Drug Safety will submit new safety information (for example, individual __ __ reports and__ __ __) to regulatory agencies, concerned Ethics Committees, and Investigators.
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case safety
cumulative line listings |
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PV - PRA will receive __ __ __for suspected, __ __ __ __from study SP 1030 within an agreed___, according to ___-specific regulatory requirements so that PRA will be able to complete the submission process within regulatory timelines.
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regulatory report forms
unexpected serious adverse reactions timeline country |
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PV - PRA will assess the individual __ ___ reports for expedited reportability to__ __, concerned__ __, and Investigators participating in the study.
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case safety
regulatory agencies Ethics Committees |
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PV - UCB transferred the responsibility of the Legal Representative in Taiwan to PRA. Consequently, PRA assumes the legal responsibility for reporting of __ information to the__ __, __ __ and ___ in Taiwan.
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Safety
regulatory authority ethics committees investigators |
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PV - Periodic Safety Reporting - Submission of periodic safety reports to__ __ , concerned__ __, and ___ are/are not required in Taiwan?
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regulatory agencies
Ethics Committees Investigators Are not |
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Types of Ethics Committees: In the EU you have an __ __ __and in the US you have ___
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Independent Ethics Committees
IRB |
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EC’s - Some countries require a multi tiered review process with both a __and ___review. The national review is sometimes referred to as a __review. For example in the EU the review is mainly done with a __ethics committee.
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National
Local Central central |
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Use of a local ethics committee is__ dependent. When used, they determine the suitability of the __and the__. So, the central is used to approve the __while the central is used to look at the specific__. CEC is a single layer ethics review;
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Country
Investigator Facility Study investigator |
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EC’s - “Central” or “local” in the US refers only to the__. A local IRB will be located geographically and will be affiliated with the ___it serves. A __IRB will serve any site that does not have an institutional requirement or a local IRB.
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Affiliation
Institution central |
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Regulatory authorities- definition - include those that __submitted clinical trial data, to decide if the drug can be __ in their country. Also refers to those that conduct__.
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Review
Marketed inspections |
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Regulatory requirements refer to the __ that are used to conduct a clinical trial in the __ where the trial is conducted. (the drug laws of different countries and related regulations).
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Laws
jurisdiction |
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An audit is an examination of clinical trial __and __to make sure done according to__, __ and __ requirements.
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Activities
Documents Protocol, GCP, regulatory |
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QC are __that are built into the process. QA is not built into the process because it is __of the process.
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Steps
independent |
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QC is performed by __ responsible for the__, while QA is performed by __that are independent of the operation.
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Staff
Output auditors |
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The Trial Master File holds all the ___for a trial. All documents are kept there.
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documentation
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One of the documents essential to the trial is the investigator brochure- includes all __and ___data on the investigational product that is relevant to the study of the product in human subjects. IB = IDB (Inv Drug Brochure)
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Clinical, nonclinical
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The FDA doesn’t differentiate between different types of amendments. In the EU, they have to differentiate between __ and __ amendments.
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Substantial, non-substantial
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A clinical study report is a written description of the study describing the __, description and __ fully integrated into a __report. This document is the result of all our actions and is used to apply for__ __.
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statitics, analyses
single marketing authorization |
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NIS Def I- A study where the medicinal product(s) is (are) prescribed in the __manner in accordance with the terms of the marketing__.
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usual , authorization
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NIS def II - The assignment of the patient to a particular therapeutic strategy is not decided in advance by a __ __but falls within the current practice and the prescription of the medicine is clearly separated from the decision to __the patient in the study.
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study protocol
include |
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NIS Def III - No additional __or __procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of the collected data.
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Diagnostic
monitoring |
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PASS def - A __-__study or a __ __carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying or quantifying a __ __relating to an authorized medicinal product.
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pharmaco-epidemiological
clinical trial safety hazard |
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Registries Def I - A registry is a __of patients presenting with the same characteristic(s).
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list
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Registries II - The patients have in common may be a __or an __(disease registry) or a specific __(exposure or drug registry).
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disease
outcome exposure |
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Registries def III-Both types of registries, which only differ by the type of patient data of interest, may collect a battery of information using standardized ___in a ___ fashion.
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Questionnaires
prospective |
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Comparative Observational Studies - Observational study designs such as __-__studies, __-__studies, and __studies (both retrospective and prospective).
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cross-sectional
case-control cohort |
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UCB considers NIS as ___ only. Then after they consider ___and they define NIS PASS study – where the main object is ___. I think PASS is collecting ___ ___ info.
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Prospective
PASS Safety Criticial safety |
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NIS nonPass – means main objective is something else like drug ___ and is still ____ only
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Utilization
Prospective |
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They also have NI - IND – that would be when objective is to provide additional __for ___. This might be a ___ request from ___
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Data
Regulatory Regulatory FDA |
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___visit means something very different in the NIS world.
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Monitoring
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