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BOPM > Acronyms > Flashcards

Acronyms Flashcards

1
Q

SPOP

A

Service provider oversight plan

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2
Q

BOR

A

Boo marker operations responsible

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3
Q

GPPS

A

Roche global pharma procurement strategic sourcing group

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4
Q

FSP

A

Functional service provider agreement

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5
Q

eTMF

A

Electronic trial master file

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6
Q

FSF

A

??

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7
Q

CRF

A

Case report form

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8
Q

DMP

A

Data management plan

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9
Q

PDC-NIS

A

Primary data collection non interventional studies

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10
Q

FFS

A

File form specifications

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11
Q

GDPR

A

General data protection regulation

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12
Q

ICF

A

Informed consent form

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13
Q

HGRAC

A

Human genetics resources administration of China

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14
Q

HGRAC

A

Human genetic resources administration of China

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15
Q

FTE

A

Full time equivalent

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16
Q

Imp

A

Investigational medicinal pooduct

17
Q

What is the cornerstone of a clinical trial and what critical information does it provide?

A

Protocol is cornerstone

Supplies critical info to rationale design and conduct of a study

18
Q

PASS

A

Post authorization safety studies

19
Q

EU QPPV

A

Role of the European Union qualified person for pharmacovigilance

20
Q

What is the European directive 2005/28/EC

A

TmF shall consist of essential documents which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.

21
Q

RRM

A

Roche reference model

22
Q

CSR

A

Clinical study report

23
Q

MHRA

A

Medicines and healthcare products regulatory agency (MHRA).

24
Q

IMP

A

Investigational medicinal product

25
Q

INF

A

Issue notification of serious gap noncompliance or misconduct form

26
Q

IVRS

A

Interactive voice response system

27
Q

PRGC

A

Pharma repository governance committee

28
Q

GVP

A

Good oharmacovigilance practice

29
Q

MAH

A

Marketing authorization holder

30
Q

PVA

A

Pharmacovigilance agreement

31
Q

PRIME

A

Priority medicines

32
Q

Ema

A

European Medicines Agency

33
Q

RADA and purpose

A

Roche active directory and administration

Gives accesss and permissions to SMT site

34
Q

EDC

A

Electronic data capture

35
Q

SDR

A

Source data review

Holistic view of patient protocol and study management to ensure processes correctly followed.

36
Q

SDV

A

Source data verification

Two way check between course and crf that data can be exchanged.

37
Q

RACT

A

Risk assessment and categorization tool

BOPM (3 decks)

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