July Work Flashcards

Front 1

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 __ __ __.

Back 1

Manuscript.
Clinical study report

Front 2

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.

Back 2

Duplication
eTMF
Phlexglobal
paper
end of study

Front 3

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 _____

Back 3

UCBs
no not ready to do this yet

Front 4

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.

Back 4

Shorter
three

Front 5

The Country Start-up Specialist (CSS), who oversees a ___of specialised staff that is assembled at a ___level for each project.

Back 5

Team
Country

Front 6

The team that the CSS oversees includes these 4 positions. (SS, C, I, CA)

Back 6

Submission Specialist -
CRA
IHCRAs
Contract Associate

Front 7

The submission specialists submits to ___ (unless submitted ___ in ____) and ___

Back 7

MoH
Centrally, English
ECs

Front 8

What role does the CRA perform in start up? Performs ____

Back 8

PSSVs

Front 9

The Contract Associate negotiates __ and ___ with sites

Back 9

Language
budget

Front 10

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)

Back 10

Activation
Recruit
Drug

Front 11

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.

Back 11

site activations
IHCRA
monitoring CRA
SIV
continuity

Front 12

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

Back 12

Country
Differences, nuances
Expertise
start-up
relationships

Front 13

Description of PV Responsibilities transferred from UCB to PRA for Taiwan study includes ___ management and __ ___.

Back 13

Safety
Expedited reporting

Front 14

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.

Back 14

case safety
cumulative line listings

Front 15

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.

Back 15

regulatory report forms
unexpected serious adverse reactions
timeline
country

Front 16

PV - PRA will assess the individual __ ___ reports for expedited reportability to__ __, concerned__ __, and Investigators participating in the study.

Back 16

case safety
regulatory agencies
Ethics Committees

Front 17

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.

Back 17

Safety
regulatory authority
ethics committees
investigators

Front 18

PV - Periodic Safety Reporting - Submission of periodic safety reports to__ __ , concerned__ __, and ___ are/are not required in Taiwan?

Back 18

regulatory agencies
Ethics Committees
Investigators
Are not

Front 19

Types of Ethics Committees: In the EU you have an __ __ __and in the US you have ___

Back 19

Independent Ethics Committees
IRB

Front 20

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.

Back 20

National
Local
Central
central

Front 21

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;

Back 21

Country
Investigator
Facility
Study
investigator

Front 22

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.

Back 22

Affiliation
Institution
central

Front 23

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__.

Back 23

Review
Marketed
inspections

Front 24

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).

Back 24

Laws
jurisdiction

Front 25

An audit is an examination of clinical trial __and __to make sure done according to__, __ and __ requirements.

Back 25

Activities
Documents
Protocol, GCP, regulatory

Front 26

QC are __that are built into the process. QA is not built into the process because it is __of the process.

Back 26

Steps
independent

Front 27

QC is performed by __ responsible for the__, while QA is performed by __that are independent of the operation.

Back 27

Staff
Output
auditors

Front 28

The Trial Master File holds all the ___for a trial. All documents are kept there.

Back 28

documentation

Front 29

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)

Back 29

Clinical, nonclinical

Front 30

The FDA doesn’t differentiate between different types of amendments. In the EU, they have to differentiate between __ and __ amendments.

Back 30

Substantial, non-substantial

Front 31

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__ __.

Back 31

statitics, analyses
single
marketing authorization

Front 32

NIS Def I- A study where the medicinal product(s) is (are) prescribed in the __manner in accordance with the terms of the marketing__.

Back 32

usual , authorization

Front 33

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.

Back 33

study protocol
include

Front 34

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.

Back 34

Diagnostic
monitoring

Front 35

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.

Back 35

pharmaco-epidemiological
clinical trial
safety hazard

Front 36

Registries Def I - A registry is a __of patients presenting with the same characteristic(s).

Back 36

list

Front 37

Registries II - The patients have in common may be a __or an __(disease registry) or a specific __(exposure or drug registry).

Back 37

disease
outcome
exposure

Front 38

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.

Back 38

Questionnaires
prospective

Front 39

Comparative Observational Studies - Observational study designs such as __-__studies, __-__studies, and __studies (both retrospective and prospective).

Back 39

cross-sectional
case-control
cohort

Front 40

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.

Back 40

Prospective
PASS
Safety
Criticial safety

Front 41

NIS nonPass – means main objective is something else like drug ___ and is still ____ only

Back 41

Utilization
Prospective

Front 42

They also have NI - IND – that would be when objective is to provide additional __for ___. This might be a ___ request from ___

Back 42

Data
Regulatory
Regulatory
FDA

Front 43

___visit means something very different in the NIS world.

Back 43

Monitoring