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Improving the infrastructure for medical research

An efficient, high-quality infrastructure is a major precondition for cutting-edge research. The principal aim of the TMF is therefore to improve the organization and infrastructure for networked medical, i.e. clinical, epidemiological and translational, research. The notion of infrastructure as an integral part of research goes well beyond purely technological issues. Accordingly, the TMF activities, projects and products can be grouped into central topics – from frameworks and IT infrastructure through quality management and biobanking to questions relating to network management and public relations.

A large majority of the TMF's work is carried out in numerous projects which, for the most part, are initiated by members and supervised by the working groups. Suggestions for new projects go through a selection process that comprises several stages – from technical evaluation and fine-tuning in the project groups and working groups through consultation in the TMF Office and assessment by the Board of Directors. This process ensures that the problems addressed in the projects are of relevance to the research community and that the solution being pursued finds a broad consensus for subsequent application.

All the TMF projects are listed below in descending chronological order. Click on the submenu items for a short description and details of the related TMF projects and products.

 

 

  1. V075-01 Seminar on Regulation of Medical Device Development
    Training seminar for clinical evaluation and clinical trials with medical devices
    (Display German project description)

     


  2. V074-01 WS Health Communication
    Workshop Health Communication in medical research networks
    (Display German project description)


  3. V073-01 Bio-Lab Saftey
    Review and amelioration of existing safety regulation for laboratories working with S3 germs
    (Display German project description)


  4. V072-01 Research Efficiency I
    Preparatory project: increasing cost-efficiency in clinical studies by using generic tools and methods such as TMF's "SAS Macros"
    (Display German project description)


  5. V071-01 ITSM
    IT-Service Management
    (Display German project description)


  6. V070-01 WS Inter-Ret
    Retrieval of participants in interventional studies based on biochemical properties - preparatory workshop
    (Display German project description)

     


  7. V067-01 WS GIS for Zoonoses
    Workshop "Web-based geo-information system for the analysis of zoonoses in Germany"
    (Display German project description)

     


  8. V065-02 MP development tools
    Clinical studies and Health Technology Asssessment for the development of medical products
    (Display German project description)


  9. V064-01 Microbiology-DB
    Development of a primary data base for the standardised storage of microbiological data
    (Display German project description)

     


  10. V063-01 Metadata repository:
    Specification of a TMF metadata repository
    (Display German project description)


  11. V062-01 Organization development:
    Organization development to ensure the sustainability of research networks
    (Display German project description)


  12. V061-01 WS ID-Management
    Workshop for the comparison of currently used solutions for the generation of PIDs (ID Management)
    (Display German project description)


  13. V060-02 WS eTrial-Challenge
    Verification of commercial providers of study management systems and RDE systems with regard to their implementation of the user role "patient" for web-based patient-controlled data entry
    (Display German project description)


  14. V060-01 Web-based patient questionnaires:
    Web-based patient questionnaires to support studies taking psychotherapeutic studies as an example
    (Display German project description)


  15. V059-01 Genotyping data workshop:
    Workshop to prepare a project on the subject of "Standardized quality control of high-throughput genotyping data"
    (Display German project description)

     


  16. V058-01 Biobanking register:
    Development of the German medical biobanking register
    (Display German project description)


  17. V056-01 Google Co-op:
    Community-oriented evaluation of health information on the Internet at Google Co-op Health: new opportunities for information providers within afgis and TMF
    (Display German project description)


  18. V054-01 IT Strategy
    Developement of an IT Strategy for Networked Medical Research in Germany
    (Display German project description)

     


  19. V053-01 Terminology workshop:
    Workshop to exchange experiences and coordinate project ideas in the fields of data dictionaries, ontologies and controlled terminologies in the TMF
    (Display German project description)


  20. V052-01 Data custodian service I:
    Catalogue of requirements for a data custodian service
    (Display German project description)


  21. V050-01 Quality assurance and registers in TMF research networks:
    Workshops on quality assurance and registers in TMF research networks
    (Display German project description)


  22. V049-01 ATC coding preliminary project:
    Clarification of the requirements for the coding of drugs in accordance with the WHO ATC classification system
    (Display German project description)


  23. V046-02 Information booth for research networks 2008:
    Contribution to costs of the information booth of the research networks at the DGIM (German Society for Internal Medicine) annual conference in April 2008
    (Display German project description)


  24. V046-01 Information booth for research networks 2006:
    Concept and realization of a common information booth for the TMF research networks at the DGIM (German Society for Internal Medicine) annual conference in 2006
    (Display German project description)


  25. V043-01 International data protection concepts workshop:
    European data protection requirements
    (Display German project description)


  26. V042-01 WS Long term archiving
    Workshop on long term archiving in clinical research
    (Display German project description)


  27. V042-01 eArchiving:
    Electronic archiving of clinical trials
    (Display German project description)

     


  28. V039-03 Data protection concept II:
    Review of the TMF generic data protection concepts
    (Display German project description)


  29. V039-02 Data protection revision preliminary project:
    Preliminary project for the further development of generic data protection concepts
    (Display German project description)


  30. V039-01 Data protection review workshop:
    Workshop: review of data protection concepts
    (Display German project description)


  31. V038-02 Monitoring score:
    Evaluation of the monitoring score from the preparatory project on GCP compliant monitoring in IITs including presentation of the results of the preparatory project as part of a workshop
    (Display German project description)


  32. V038-01 IIT monitoring:
    Preparatory project on GCP compliant monitoring in IITs
    (Display German project description)


  33. V037-01 CME:
    Preparatory project on offers from TMF e.V. member networks for Continuing Medical Education (CME)
    (Display German project description)


  34. V035-01 Process analysis of clinical trials:
    Preliminary project on the systemization and modeling of working procedures in clinical trials
    (Display German project description)


  35. V034-01 SDTM converter:
    Tools for exporting data to a CDISC SDTM structure
    (Display German project description)


  36. V033-01 CDISC II:
    Case studies for data management in clinical trials to meet CDISC format requirements
    (Display German project description)


  37. V032-04 SOPs IV:
    Updating and translation of selected SOPs as well as the creation of a new SOP
    (Display German project description)


  38. V032-03 SOPs III:
    Continuation of the "Standard Operating Procedures" project for carrying out clinical trials including IITs in accordance with the provisions of the 12th amendment to the German Pharmaceuticals Products Act (AMG)
    (Display German project description)

     


  39. V032-02 SOPs II:
    Further work packages on "Standard Operating Procedures" for the implementation of clinical tests including IITs in accordance with the regulations of the 12th amendment to the German Pharmaceutical Products Act (AMG)
    (Display German project description)


  40. V032-01 SOPs I:
    "Standard Operating Procedures" (SOPs) for the implementation of clinical trials including IITs in accordance with the provisions of the 12th amendment to the German Pharmaceutical Products Act (AMG)
    (Display German project description)

     


  41. V030-01 MedDRA:
    Concept development for use of MedDRA coding in trials
    (Display German project description)


  42. V029-01 SAE management:
    SAE management and reporting of side effects in accordance with the provisions of the 12th amendment to the German Pharmaceutical Products Act (AMG)
    (Display German project description)


  43. V028-01 German Pharmaceutical Products Act (AMG) checklist:
    Checklist for carrying out clinical trials in accordance with the provisions of the amended German Pharmaceutical Products Act (AMG) and the GCP Ordinance
    (Display German project description)


  44. V027-01 German Pharmaceutical Products Act (AMG) training:
    Conceptual development of training and information material on the implications of the 12th amendment to the German Pharmaceutical Products Act for carrying out IITs with a focus on treatment optimization trials
    (Display German project description)

     


  45. V026-01 Expert opinion on pseudonymization:
    Legal advice for research networks on the new requirements regarding the obligation to pseudonymize research data including for ongoing treatment as a result of the new German Pharmaceutical Products Act (AMG)
    (Display German project description)


  46. V025-01 HPC:
    Analysis of requirements for the Health Professional Card from the perspective of medical research
    (Display German project description)


  47. V024-02 Enhancement of the clinical guideline portal
    Implementation of methodical features into the clinical guideline online collaboration portal
    (Display German project description)

     


  48. V024-01 IT for guideline development:
    IT infrastructure for developing and updating guidelines
    (Display German project description)

     


  49. V023-01 Web quality assurance:
    Development and standardization of methods and metrics for the evaluation and quality assurance of medical information offers
    (Display German project description)

     


  50. V022-02 DocSys interfaces:
    Main project: specification and evaluation of interfaces between documentation systems in practices and hospitals and the registers of the medical competence networks – formal description of solutions
    (Display German project description)


  51. V022-01 WS DocSys interfaces:
    Workshop on the development of a project application: specification and evaluation of interfaces between documentation systems in practices and hospitals and the registers of the medical competence networks
    (Display German project description)


  52. V021-01 MAKS I:
    SAS Macro Library for Clinical Trials in the CDISC SDTM Structure
    (Display German project description)


  53. V020-01 Data quality:
    Development of guidelines for the adaptive management of data quality in cohort trials and registers
    (Display German project description)


  54. V019-02 Training evaluation:
    Evaluation of the results of the training concept of the system validation project as part of exemplary training with subsequent evaluation
    (Display German project description)


  55. V019-01 System validation II:
    System validation – use, evaluation and expansion of the validation package
    (Display German project description)


  56. V017-03 Informed consent declarations, trauma:
    Development of recommendations for "Patient information and informed consent declarations" as part of research plans with acute adult patients who are initially unable to give consent
    (Display German project description)


  57. V017-02 Informed consent declarations, paed I:
    Development of guidelines for "Patient information and informed consent declarations" as part of clinical trials with children and adolescents. Preliminary project: analysis of actual situation
    (Display German project description)


  58. V017-01 Informed consent declarations, general II:
    Updating of the commented checklist "Patient information and informed consent declarations" for use in medical research networks
    (Display German project description)


  59. V016-01 Safety concepts:
    Safety concepts in research networks – application of basic IT protection
    (Display German project description)


  60. V015-02 PID generator workshop:
    User workshop on the PID generator
    (Display German project description)


  61. V015-01 PID Generator:
    Further development of the PID generator
    (Display German project description)


  62. V014-01 Data protection concept A:
    Comprehensive documentation and demo installation of a productively applied solution for the generic data protection concept A which can be freely used within the TMF e.V.
    (Display German project description)

     


  63. V010-02 Biobanking EUCoop
    Legal basis of EU-wide biobanking cooperation
    (Display German project description)

    1. English project description

  64. V010-01 Biobanking:
    Legal basis and framework for biobanking development and operation
    (Display German project description)


  65. V009-01 CDISC I:
    Expansion of the use of RDE software by means of metadata exchange via CDISC
    (Display German project description)


  66. V006-02 Mobile computing workshop:
    Workshop on the existing TMF solutions in the field of mobile computing
    (Display German project description)


  67. V006-01 Mobile computing:
    Investigations on the use of mobile computing in the TMF e.V. research networks
    (Display German project description)

     


  68. V004-01 Infotainment:
    Exhibition concept for the presentation of the Competence Networks in Medicine
    (Display German project description)


  69. V002-01 German Pharmaceutical Products Act (AMG) workshop:
    Carrying out of clinical trials as of May 1, 2004 – application and the rendering applicable of the new AMG and its statutory ordinance
    (Display German project description)


  70. V001-01 KOKOS I:
    "Networked clinical research in Germany introduces itself"
    (Display German project description)


  71. V000-01 PS service:
    Pseudonymization service
    (Display German project description)

     


  72. D025-02 P2B2
    Project portal in the German Biobank Registry (P2B2)
    (Display German project description)

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  73. D025-01 Registry and Portal for Biobanks
    Development of a German biobank registry with an integrated user portal
    (Display German project description)

    Dr. Dr. Michael Kiehntopf
    University of Jena
    Phone: +49 3641 / 9 32 50 20
    E-Mail

     
    Sebastian C. Semler
    TMF Office
    Phone: +49 30 / 31 01 19 50
    E-Mail


  74. D023-01 HIS-based recruitment
    Supporting recruitment in clinical trials with help of hospital information systems
    (Display German project description)


  75. D021-01 Metadata Repository

    (Display German project description)


  76. D019-01 Pilotstudy Biobanking
    Proving of networking possibilities for biobanks in German research networks
    (Display German project description)


  77. D018-01 Zoonosis Platform
    National Research Platform for Zoonoses
    (Display German project description)


  78. D014-01 EATRIS (EU-Project)
    European Advanced Translational Research Infrastructure in Medicine
    (Display German project description)


  79. D010-01 SOP System
    Development of a comprehensive and sustainable set of Standard Operating Procedures (SOPs) for investigator initiated clinical trials (IITs)
    (Display German project description)

     


  80. D006-01 QM for genotyping
    Quality Management for high-throughput genotyping
    (Display German project description)


  81. D005-01 ADAMON
    Prospective cluster-randomised study for the validation of a new method for defining adapted monitoring strategies for clinical studies
    (Display German project description)

     


  82. D001-02 Pneumogrid
    Grid enabled signal processing for dynamic imaging of respiration with healthy persons and patients suffering Chronic Obstructive Pulmonary Disease (COPD)
    (Display German project description)


  83. D001-01 MediGRID
    Grid Computing in biomedical research
    (Display German project description)
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