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

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

Overview ➢ Background ➢ Extracts of KoRegIT results ➢ How to use ➢ Summary - further steps TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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 TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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. TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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 !"#$% &'($) on the identified tasks • *" &+,-)+. '/) (+.."01 ' !"#$% •To have a better basis for negotiations with investors and funding organizations • *" $21$/) '/) ".1,3,4$ $2,(1,/% !"#$% • 555 TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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. TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Example for KoReg overall organisation/- processes I Organigramm KompNet HIV TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Example for KoReg overall organisation/- processes II Management structure of NatKo Technical structure of study centers NatKo TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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 KoRegs: ;.&#</&.-#**#* .6 • 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 TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Methods: Structure of requirements 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) TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

KoRegIT Phase-modell 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$2$&. TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Results: Extract of catalogue of requirements TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Methods: actors with their definition and roles (Personnel management) TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Methods: Use Case Template TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Results: Specification 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) TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Methods: involved KoReg workinggroups and experts 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), TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Use of KoRegIT To support the core processes of a KoReg by computerized application systemes !" # easible solutions: Modular solution or all-embracing solution Surveilance of KoReg: ! $%&'(() a modular solution is set in which realize different parts of the core-prozesses TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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 TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Results: Use of catalogue IT requirement: e.g . EDC system (TL010), +integrated or external document-management system (TL003,001,047,006, 009), TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

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) TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Results: Use of catalogue like checklist TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Thanks 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 TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Summary and further steps 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 TMF, Telematikplattform für Medizinische Forschungsnetze e. V. KoRegIT Seite 0

Thank You! Further information and draft catalogue Claudia.Michalik@zks-koeln.de TMF, Telematikplattform für Medizinische Forschungsnetze e. V. Michalik, Mie 2014 KoRegIT