Acronyms

Question 1

SPOP

Answer 1

Service provider oversight plan

Question 2

BOR

Answer 2

Boo marker operations responsible

Question 3

GPPS

Answer 3

Roche global pharma procurement strategic sourcing group

Question 4

FSP

Answer 4

Functional service provider agreement

Question 5

eTMF

Answer 5

Electronic trial master file

Question 6

FSF

Answer 6

??

Question 7

CRF

Answer 7

Case report form

Question 8

DMP

Answer 8

Data management plan

Question 9

PDC-NIS

Answer 9

Primary data collection non interventional studies

Question 10

FFS

Answer 10

File form specifications

Question 11

GDPR

Answer 11

General data protection regulation

Question 12

ICF

Answer 12

Informed consent form

Question 13

HGRAC

Answer 13

Human genetics resources administration of China

Question 14

HGRAC

Answer 14

Human genetic resources administration of China

Question 15

FTE

Answer 15

Full time equivalent

Question 16

Imp

Answer 16

Investigational medicinal pooduct

Question 17

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

Answer 17

Protocol is cornerstone

Supplies critical info to rationale design and conduct of a study

Question 18

PASS

Answer 18

Post authorization safety studies

Question 19

EU QPPV

Answer 19

Role of the European Union qualified person for pharmacovigilance

Question 20

What is the European directive 2005/28/EC

Answer 20

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.

Question 21

RRM

Answer 21

Roche reference model

Question 22

CSR

Answer 22

Clinical study report

Question 23

MHRA

Answer 23

Medicines and healthcare products regulatory agency (MHRA).

Question 24

IMP

Answer 24

Investigational medicinal product

Question 25

INF

Answer 25

Issue notification of serious gap noncompliance or misconduct form

Question 26

IVRS

Answer 26

Interactive voice response system

Question 27

PRGC

Answer 27

Pharma repository governance committee

Question 28

GVP

Answer 28

Good oharmacovigilance practice

Question 29

MAH

Answer 29

Marketing authorization holder

Question 30

PVA

Answer 30

Pharmacovigilance agreement

Question 31

PRIME

Answer 31

Priority medicines

Question 32

Ema

Answer 32

European Medicines Agency

Question 33

RADA and purpose

Answer 33

Roche active directory and administration Gives accesss and permissions to SMT site

Question 34

EDC

Answer 34

Electronic data capture

Question 35

SDR

Answer 35

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

Question 36

SDV

Answer 36

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

Question 37

RACT

Answer 37

Risk assessment and categorization tool