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Pdg In Ssf > Pdg Bopm Functional > Flashcards

Pdg Bopm Functional Flashcards

(73 cards)

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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
GCSR
Smt Global study manager responsible Rovides cco perspective to smt
26
Safety scientist
SMT | Addresses questions related to safety profile of molecule
27
CRO project manager
Smt | Outsourced studies, lead on cro study team
28
Site monitor
Not on smt | Monitor site activities
29
PSC
Project support coordinators Smt Responsible to support sample reconciliation so that sample data queries are resolved prior to analysis
30
Clinical pharmacologist
Ad hoc smt | Define pharmacology analysis
31
Regulatory partner
Ad hoc smt | Address reg submission reqts, site inspections
32
BAM
Ad hoc smt Bioanalytical manager Support operational and analytical work required to conduct pharmacology analysis
33
DAS
Data acquisition specialist Ad hoc smt Responsible for specifications, acquisition, loading and delivery of non CRF data at study level.
34
BM
Ad hoc smt Sourcing vendors Negotiate con tract terms and budget Resolve vendor issues
35
CSM
County study manager Ad hoc Maintain full ownership of affiliate portion
36
Quality
Ad hoc | Audit strategy and program across service provider
37
CDSL
Ad hoc Clinical demand and supply leader Point of contact to initiate plans for clinical investigational medicinal product (IMP)
38
BOM
Biosample operation manager | Ad hoc
39
SDCRe
Sample data cleaning and reporting using an eManifest
40
List sample identifying variables
ACCSNM non TDQ samples PRACCSNM previous accession numbers RRID for TDQ studies
41
Examples of patient identifiers and purpose
PATNUM | SCRNUM
42
Vts
Visit test schedule
43
GDPR
Global data protection regulation (there is a European version)
44
CDISC
Clinical data interchange standards consortium
45
CDISC
Clinical data interchange standards consortium
46
SDTM
Study data tabulation model Model for mapping standards
47
SDTM
Study data tabulation model Model for mapping standards
48
COMAS
Contracts management system
49
RRID
Roche reference ID: | A single specimen identifier to be the key link to tissue metadata and vendor biomarker data.
50
PRGS
Pharma repository governance committee
51
RCR
Roche clinical repository
52
DOR
Duration of response
53
ATA
Anti therapeutic antibody
54
ASCO
American society of clin oncology
55
DCR
Disease control rate
56
ECOG
Eastern cooperative oncology group
57
MTD
Maximum tolerable dose
58
Orr
Objective response rate
59
OS
Overall survival
60
PR
Partial response
61
PRO
Patient reported outcome
62
ALK IHC testing platform
Ventana Benchmark XT
63
EGFR assay platform
Roche cobras EGFR
64
DHS
Dirty hold study
65
FMI prospective testing description
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
FMI Retrospective Testing
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
MIP
Multi instrument platform Multi indication pricing
68
SREP
Study results endorsement plan
69
SPOC
Single point of contact
70
CFAT
Cross functional alignment team
71
DAS
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
Cost center
1950; based on legal entity of the contract.
73
DLT
Dose limiting toxicity

Pdg In Ssf (1 decks)

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