Safety Related

Front 1

Number of SAE inlucdes ___ SAEs which occur to a ___ enrolled in the study

Back 1

all
patient

Front 2

What does SUSAR stand for?

Back 2

suspected unexpected serious adverse reactions

Front 3

Number of reportable SAE definition is SAEs which have to be reported in an ___ manner to __, __/___ and ___.

Back 3

expedited
regulatory authorities, IRB/ECs and sites

Front 4

The number of reportable SAE are mainly ___ but based on country regulations can include other ___, like SESAR (suspected expected serious adverse reactions).

Back 4

SUSARs
SAEs

Front 5

PRA's drug safety centers provide a full spectrum of services including 24/7 ___/___ coverage

Back 5

medical/safety

Front 6

PRA's drug safety centers provide a full spectrum of services including protocol or product specific ___ and ___ management plans

Back 6

safety and medical

Front 7

PRA's drug safety centers provide a full spectrum of services including ___/___/___ recpeit and acknowledgement, triage data entry, etc.

Back 7

SAE/ADR/MDR

Front 8

PRA's drug safety centers provide a full spectrum of services including SAE/ADR/MDR ___ reporting to authorities and AE/SAE ___

Back 8

expedited
reconciliation

Front 9

PRA's drug safety centers provide a full spectrum of services including a central repository of regulatory ___ requirements for more than ___ countries

Back 9

reporting
60

Front 10

PRA's drug safety centers provide a full spectrum of services including ___ web-based, fully validated safety ___ tracking system

Back 10

Oracle
letter

Front 11

Minimizing the risk to patient ___ has become an increasingly important international requirement of drug development

Back 11

safety

Front 12

Reg authorities are holding ___ accountable for the demonstration of proper and thorough safety management

Back 12

sponsors

Front 13

FDA, EMA and ICH guidance on the development of ___ minimization plans have resulted in the need for ___ risk minimization strategies for the entire lifecycle of a product

Back 13

risk
individual

Front 14

PRA's safety and risk management teams helps clients design, implement and operationalize the proper safety __.

Back 14

procedures

Front 15

For the MANAGEMENT OF INDIVIDUAL SAFETY REPORTS, our __ ___ ___ in Mannheim, Swansea, Charlottesville and ___ ___ provide the full spectrum of safety management related to the processing of SAEs, ADRs and MDRs

Back 15

drug safety centers
Sao Paolo, Brazil

Front 16

What does ADR stand for?

Back 16

Adverse drug reactions

Front 17

What does MDR stand for?

Back 17

Medical Device Reports

Front 18

For REGULATORY SAFETY REPORTING, in addition to individual case safety reporting, we regularly prepare and submit these 4 reports (AS, PSUR, PADER, DER)

Back 18

annual safety reports
periodic safety update reports
periodic adverse drug experience reports
investigational new drug safety reports.

Front 19

We are also fully prepared for ___ reports

Back 19

Development sAfety Update reports

Front 20

Our drug saftey group works closely with __&__ services and __&___ teams to ensure that all relevant __ are included within safety documents

Back 20

Data&Programming
Biostatistics & Medical writing
data

Front 21

Safety letters must be submitted to __/___ and ___

Back 21

IRB's/EC's and sites

Front 22

Cumulative Safety reports are sent to ___

Back 22

Regulatory authorities

Front 23

EXPEDITED REPORTING and e-SAFETY LETTER - we offer ___ compliant reporting from our ___ AERS safety database.

Back 23

E2B
Oracle

Front 24

We have knowledge of safety reporting regulatory requirements in over __ countries and are well placed to deal with individual country __

Back 24

60
nuances

Front 25

We use e-Safety letter distribution in addition to ___ or ___ to send safety letters to sites.

Back 25

courrier shipment or faxing

Front 26

We have a __ ___ tracking system in Oracle

Back 26

safety letter

Front 27

The transparency and visibility of data is an increasing client requirement so we provide clients access to our __ __ via the portal.

Back 27

safety database

Front 28

The whole point of Safety & Risk Management is ____

Back 28

protecting the patient's safety

Front 29

PRA offers a safety ___ and ___-___ assessment, one of the most effective means of monitoring a product's safety profile.

Back 29

profiling
benefit-risk

Front 30

Additionally, for clinical trials and post approval studies, our medical team undertakes ____ patient reviews to detect safety issues

Back 30

continuous

Front 31

Our safety and medical monitoring teams use ___ to search the clinical and safety data of a clinical trial for potential safety signals duirng studies.

Back 31

J-Review

Front 32

J-Review faciliates the uses of a standardized MedDRA query tool to identify any ___ against a set of pre-defined questions around selected terms associated with __ __ of a product

Back 32

anomalies
adverse events

Front 33

For costing purposes, if you have 75 reportable SAE’s you need to figure out how many __ ___ they need to be submitted to.

Back 33

regulatory authorities

Front 34

For the safety reports, normally only the __ __ has to be translated. A country that requires the translation of the safety report itself is ___

Back 34

cover letter.
Russia