Claudia Michalik Clinical Trial Centre (ZKS), University Cologne, - - PDF document

TMF, Telematikplattform für Medizinische Forschungsnetze e. V. Michalik, Mie 2014 KoRegIT

Requirements and tasks of cohorte and registers, the German KoRegIT project ID 174

Claudia Michalik

Clinical Trial Centre (ZKS), University Cologne, Germany Competencenetwork for HIV/AIDS MIE, Istanbul 02. September 2014

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➢ Background ➢ Extracts of KoRegIT results ➢ How to use ➢ Summary - further steps Overview

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KoRegIT: Background I Cohorts and registers (KoReg) are long lasting and complex research projects,

• need of systematic and extensive planning and steering
• need of long lasting and flexible IT-support
• to be prepared for n!" #!$%&#!'!()* !+,+
• Integration of biomaterialbank
• Intendation of clinical studies and other research projects
• Extension of qualitäty management
• Adoption to new cooperations
• central basic module for planning and operation of an appropriate

IT-infrastructure is a precise investigation of requirements

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KoReg(IT) Background II

• Literature of KoReg mainly addresses the study design and

analyses

• Surveillance within research groups and KoReg showed the

need of a catalogue requirements and tasks

• The different tasks related to
• building up,
• administrating,
• managing and maintaining the quality of a KoReg
• collecting and analysing the data

!should be identified in detail.

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Objectives KoRegIT The Project KoRegIT aims to close the gap of a generic catalogue of requirements for cohorts and registers.

• To derive the IT-Solutions/IT-Infrastructure for !"#$% &'($)
• n the identified tasks
• *" &+,-)+. '/) (+.."01 ' !"#$%
• To have a better basis for negotiations with investors and funding
• rganizations
• *" $21$/) '/) ".1,3,4$ $2,(1,/% !"#$%
• 555

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KoReg(IT): need for a catalogue of requirements …

The core of KoReg consists of the data of interest but The organisational structure and processes with different participating groups and responsibilities are just as important as the data itself.

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Example for KoReg overall organisation/- processes I

Organigramm KompNet HIV

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Example for KoReg overall organisation/- processes II

Technical structure of study centers NatKo Management structure of NatKo

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Methods: concentration on core-processes

!"# $#%#&'()#$ *+*%#',%(- -.'/&(*#* !"# $#%#&'()#$ *+*%#',%(- -.'/&(*#* %./ 0#1#0 2!34 %,*5* .6 %"# -.&# %./ 0#1#0 2!34 %,*5* .6 %"# -.&# /&.-#**#* .6 7.8#9: /&.-#**#* .6 7.8#9: ;.&#</&.-#**#* .6 ;.&#</&.-#**#* .6 KoRegs:

• Communication with study sites
• Administraion of patients rsp. probands
• Management of data from survey to monitoring
• Analysis and use of data

Supporting processes

• Personnel administration, book keeping
• IT-Service-Management (few exceptions)

= were not included to reduce the complexity

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Phase-modell

• Based on recomendations of the DNVF (ger. Network healthcare

research) and the AHRQ (Agency f. Healthcare Research and Quality)

Top-level-tasks

• 45 (version 0.8)

Use cases

• 207 (version 0.8)

Result documents

• Catalogue of requirements
• List of Top-Level-tasks and Use Cases in Excel
• Specification
• Structured description of the Use Cases in Word (181 pages)

Methods: Structure of requirements

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Development

• Planning ! e.g. Protocol development,
• Preperation ! e.g. development of Subject information and informed

consent documents, Recruitment of sites

Operation

• Implementation ! e.g. Recruitment of p"#$%&#' ()

*)(+"&,'

• Use ! e.g. statistical analyses, publication
• Further Development ! tasks of the phase of planning can be occur in

each phase of a KoReg lifecycle

Completion

! %-.- /)01$2$&.

KoRegIT Phase-modell

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Results: Extract of catalogue of requirements

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Methods: actors with their definition and roles (Personnel management)

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Methods: Use Case Template

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Phase-modell

• Based on recomendations of the DNVF (ger. Network healthcare

research) and the AHRQ (Agency f. Healthcare Research and Quality)

Top-level-tasks

• 45 (version 0.8)

Use cases

• 207 (version 0.8)

Result documents

• Catalogue of requirements
• List of Top-Level-tasks and Use Cases in Excel
• Specification
• Structured description of the Use Cases in Word (181 pages)

Results: Specification

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Kompetenznetz HIV/AIDS – ZKS Köln

• Claudia Michalik, Jochen Dreß

Kompetenznetz Hepatitis

• Jürgen Stausberg, Thomas Müller, Sylvie MN Ngouongo,

Nationale Kohorte

• Daniel Kraft, Stefan Ostrzinski

GTDS-Entwicklerzentrum

• Udo Altmann

Mukoviszidose e. V. und Partner

• Martin Stern, Marguerite Honer,

IMSIE Leipzig

• Sebastian Stäubert, Ulrike Weber

Expertenreviews

• Gisela Antony (KN MS), Ulrike Bauer (KN AHF), Thomas Ganslandt

Med.Informatik UK Erlangen), Klaus Pommerening (IMBEI Mainz, TMF),

Methods: involved KoReg workinggroups and experts

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Use of KoRegIT

Modular solution or all-embracing solution To support the core processes of a KoReg by computerized application systemes !" #easible solutions: Surveilance of KoReg: ! $%&'(() a modular solution is set in which realize different parts of the core-prozesses

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Use KoRegIT by modular architekture

TL tasks and UC could be compiled according to their associated function !"#$%& '( #)*'% &+*"','" %$-*& .*# / )$0$.*(*$1& "$0+1#*%23$%42 &#/#'$(5 *6.6 #)* 7/#/20/(/.*% #$ &$-8* )'& #/&4&6

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Results: Use of catalogue

IT requirement: e.g. EDC system (TL010), +integrated or external document-management system (TL003,001,047,006, 009),

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Results: Use of catalogue

TL028 Study support Phase: Operation TL029 Statistical analyses TL030 Reporting TL031 Organization of publication and präsentations TL033 Data-integration, Data-combination TL046 Support of patient care IT requirement: e.g. EDC system with options to integrate studies (TL028) + Statistic software (TL029, 033) (integrated module or external software)

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Results: Use of catalogue like checklist

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Project is supported by: TMF – Technology, Methods and Infrastructure for networked medical research. „The TMF provides advices, generic concepts, guidelines and IT appplication for medical research and offers consulting and training by their working groups.“ www.tmf-ev.de

! KoRegIT new Tool of TMF

Thanks

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➢ KoRegIT supports planning and management of KoReg in general and the IT –infrastructure of cohorts and registers. ➢ Results could use as a reference catalogue ! "#$%& '( )&#*+ individually for KoReg ➢ Version 0.8 (Beta-Version 181) available ! linkage of Word + Excel document ! ,#--.'%( )&&.+.#/)% *0#1("+2 +0)/-%)+.#/ ./ (/3%.-4 Summary and further steps

TMF, Telematikplattform für Medizinische Forschungsnetze e. V. Michalik, Mie 2014 KoRegIT

Thank You!

Further information and draft catalogue Claudia.Michalik@zks-koeln.de