Transcript presentation

CD12 - Implementing metadata standards at the protocol level
12 July 2016
Implementing
metadata
standards at the
protocol level
Phuse Berlin
October 2010
Annabel Acs
[email protected]
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Slide no 2
CD12 - Implementing metadata standards at the protocol level
Standard
Technology
Process
12 July 2016
Slide no 3
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Slide no 4
The standards and technology at NN
CRF
CRF
CRF
Date:
Protocol
Standards
CRF
Standards
Submission
Standard
/ /
Abc
:
x:
y:
Qwr:
CDISC SDTM
ADaM
Data Domain: CDISC
PE
Standard
DCM/DVGs
Numeric Findings
Visits
Responses
Categoric Findings
Mapping
rules
Standard
Code Values
<XML>
.…
Std. EOT
Events
(AE/Hypo/x)
XXCgfg hghj dklædfjkll sdfkf jklsd
-----------------------------------
Interventions
Xxxx
Elements
Table
Standard
Mappings
CDW
Subject
OC
Table
Data Domain: ADPE
<XML>
.…
Standard
Reports
Xxx
1223
456. 7789.0
Xxxx
1223
456. 7789.0
Xxxx
1223
456. 7789.0
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Slide no 5
The process supporting standards
and technology at NN
Trial
Data
Programm
ers
Managem
ent
Managem
ent
and
Statisticia
ns
PMT
technology
• Protocol Metadata
Template (Excel)
•
•
•
•
Inexpensive
Easy to use
Easy to modify
Familiar to
everyone
CD12 - Implementing metadata standards at the protocol level
Protocol
Metadata
Template
standards
12 July 2016
WBC
Leucocytes
White
Blood
Cells
Slide no 8
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Trial Design defined in CDW-O with
protocol attributes
Slide no 12
CD12 - Implementing metadata standards at the protocol level
12 July 2016
The process supporting the
standards and technology
Protocol
Draft
Protocol
Metadata
Template
Protocol
1.0
Slide no 16
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Slide no 17
The process supporting the
standards and technology
Trial
Mng
•Time
•New tool
•Admin.
Data
Mng
Program
mers and
Statistici
ans
Medical
Writers
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Slide no 18
SOPs
Training
Mng Attn.
Improving the
process…
New
Processes
Trial
Mng
Data
Mng
Program
mers and
Statistici
ans
Medical
Writers
CD12 - Implementing metadata standards at the protocol level
12 July 2016
Slide no 19
Vision for future Clinical System Architecture
Portal
eRandom
CTMS
IWRS
EDC
Set Up
eStandard
eProtocol
eDCS
Set-up
eSPS
ePSPS
Metadata
Repository
Other
eRecords
LAB
Safety
Conduct
Verify
SCE
BI
cBI
Analyze
Clinical
Source Data Enrich
Repository
Enriched
Clinical
Data
Repository
PACT
eCTD
Publish
Analyse
Submission
Outputs
Repository
Process Data Repository
Master Data
Training & Processes
Dictionaries
Coding