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Pdg In Ssf > Pdg Bopm Functional > Flashcards

Pdg Bopm Functional Flashcards

1
Q

COPP

A

Clinical operations process portal

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2
Q

PDMA

A

Product development medical affairs

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3
Q

Gpd

A

Global procedural dox

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4
Q

OPL

A

Operations programme lead

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5
Q

CTMS

A

Clinical trial management system

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6
Q

bPO

A

Business process ownership

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7
Q

SDCRe

A

Study data cleaning and reporting using an eManifest

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8
Q

OSR

A

Outsourced sample reconciliation

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9
Q

SDC policy

A

Single data collection (sdc)

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10
Q

BCE

A

Biostatistics computing environment

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11
Q

PSC

A

Project support coordinator

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12
Q

DRR

A

Data review report

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13
Q

OSR

A

Outsourced sample reconciliation

Used when both the eCRF database and sample management are outsourced.

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14
Q

Good Clinical Practice

A

International standard describing the responsibilities and expectations of all participants in the conduct of linical trials, including investigators,monitors, sponsors and IRBs. It is the responsibility of roche to ensure that clinical trials are conducted in accordance with GCP.

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15
Q

Define protocol

A

Describes the rationale and background for the clinical trial

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16
Q

Informed consent

A

Process by which a subject voluntarily confirms his/her willingness to participate in a trial. A master UCD is created but additional versions may be amended to reflect county or site-specific requirements. Master ICF. And additional versions must be reviewed by you as a BOM

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17
Q

GD

A

Global dossier

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18
Q

RAPID

A

Location for protocol and ICF templates

Roche automated production of integrated dossier

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19
Q

DSLC

A

Data sharing leadership committee

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20
Q

GSL

A

Global study leader
Part of smt
Provide leadership to smt, establishment of timelines, budget, risk oversight of tmf
Comm with opl

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21
Q

GSM

A

Global study manager
Operational elements
Feasibility and site selection with cro and Co

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22
Q

SDM

A

Study data manager

Leadership planning and delivery of data management (case report form)

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23
Q

Clinical scientist

A

Writes protocol and informed consent form

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24
Q

Biostatisticians

A

Smt

Define statistical analysis plan

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25
Q

GCSR

A

Smt
Global study manager responsible
Rovides cco perspective to smt

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26
Q

Safety scientist

A

SMT

Addresses questions related to safety profile of molecule

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27
Q

CRO project manager

A

Smt

Outsourced studies, lead on cro study team

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28
Q

Site monitor

A

Not on smt

Monitor site activities

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29
Q

PSC

A

Project support coordinators
Smt
Responsible to support sample reconciliation so that sample data queries are resolved prior to analysis

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30
Q

Clinical pharmacologist

A

Ad hoc smt

Define pharmacology analysis

31
Q

Regulatory partner

A

Ad hoc smt

Address reg submission reqts, site inspections

32
Q

BAM

A

Ad hoc smt
Bioanalytical manager
Support operational and analytical work required to conduct pharmacology analysis

33
Q

DAS

A

Data acquisition specialist
Ad hoc smt
Responsible for specifications, acquisition, loading and delivery of non CRF data at study level.

34
Q

BM

A

Ad hoc smt
Sourcing vendors
Negotiate con tract terms and budget
Resolve vendor issues

35
Q

CSM

A

County study manager
Ad hoc
Maintain full ownership of affiliate portion

36
Q

Quality

A

Ad hoc

Audit strategy and program across service provider

37
Q

CDSL

A

Ad hoc
Clinical demand and supply leader
Point of contact to initiate plans for clinical investigational medicinal product (IMP)

38
Q

BOM

A

Biosample operation manager

Ad hoc

39
Q

SDCRe

A

Sample data cleaning and reporting using an eManifest

40
Q

List sample identifying variables

A

ACCSNM non TDQ samples
PRACCSNM previous accession numbers
RRID for TDQ studies

41
Q

Examples of patient identifiers and purpose

A

PATNUM

SCRNUM

42
Q

Vts

A

Visit test schedule

43
Q

GDPR

A

Global data protection regulation (there is a European version)

44
Q

CDISC

A

Clinical data interchange standards consortium

45
Q

CDISC

A

Clinical data interchange standards consortium

46
Q

SDTM

A

Study data tabulation model

Model for mapping standards

47
Q

SDTM

A

Study data tabulation model

Model for mapping standards

48
Q

COMAS

A

Contracts management system

49
Q

RRID

A

Roche reference ID:

A single specimen identifier to be the key link to tissue metadata and vendor biomarker data.

50
Q

PRGS

A

Pharma repository governance committee

51
Q

RCR

A

Roche clinical repository

52
Q

DOR

A

Duration of response

53
Q

ATA

A

Anti therapeutic antibody

54
Q

ASCO

A

American society of clin oncology

55
Q

DCR

A

Disease control rate

56
Q

ECOG

A

Eastern cooperative oncology group

57
Q

MTD

A

Maximum tolerable dose

58
Q

Orr

A

Objective response rate

59
Q

OS

A

Overall survival

60
Q

PR

A

Partial response

61
Q

PRO

A

Patient reported outcome

62
Q

ALK IHC testing platform

A

Ventana Benchmark XT

63
Q

EGFR assay platform

A

Roche cobras EGFR

64
Q

DHS

A

Dirty hold study

65
Q

FMI prospective testing description

A
  1. For enrollment done at progression/relapse
  2. TAT: 10-14 days from receipt and reconciliation
  3. CLIA report provided to sites for progression samples
  4. Patient cone sent to testing/receiving report is required
  5. FMI testing describes in clinical study protocol and ICF
66
Q

FMI Retrospective Testing

A
  1. For exploratory biomarker research
  2. TAT 6-8 weeks from receipt and reconciliation at FMI
  3. Report NOT provided to sites
  4. NGStesting describes in the clinical study protocol, but FMI is not mentioned.
67
Q

MIP

A

Multi instrument platform

Multi indication pricing

68
Q

SREP

A

Study results endorsement plan

69
Q

SPOC

A

Single point of contact

70
Q

CFAT

A

Cross functional alignment team

71
Q

DAS

A

Ensures that data passes conformance checks before delivering to CP. this is done with the FFs which help set up conformance checks in entimICE.

72
Q

Cost center

A

1950; based on legal entity of the contract.

73
Q

DLT

A

Dose limiting toxicity

Pdg In Ssf (1 decks)

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