P000011 - Pseudonymisation software
Software for the use of a specialized TMF IT infrastructure for the symmetrical encryption of single-level pseudonyms
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P000021 - Generic data protection concepts
Reng M, Debold P, Specker C, Pommerening K: Generic data protection solutions for medical research networks, Berlin 2006 (TMF book series, vol. 1)
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P000031 - Expert opinion on sponsor responsibility
Brief expert opinion on assuming responsibility as a sponsor in clinical studies
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P000032 - Specimen documents on sponsor responsibility
Templates for contracts with trial sites and contractors and specimens for internal task assignment
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P010011 - Legal Opinion on Biobanking
Simon JW, Paslack R, Robienski J, Goebel JW, Krawczak M: Biobanking – Legal framework, Berlin 2006 (TMF book series, vol. 2)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
E-Mail
P010012 - Specimen Contracts for Biobanking
Specimen TMF texts and contracts for the development and operation of biobanks
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
E-Mail
P010021 - Data Protection Concept for Biobanking
Pommerening K, Hummel M, Ihle P, Semler SC: Biobanking – Data protection and ethical aspects, Berlin 2008 (TMF series of publications, vol. 6)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
E-Mail
P010031 - Quality Management in Biobanking
Kiehntopf M, Böer K: Biobanking – Checklist for quality assurance, Berlin 2008 (TMF book series, vol. 5)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
E-Mail
P010211 - BMB Co-operation in the EU
Summarised expert opinions and generic texts for German biobanks in EU-wide co-operation projects
Contact Person:
Johannes Drepper
Tel.: ++49 (30) 31 01 19 53
E-Mail
P014011 - Reference implementation of data protection concept (model A)
Software and documentation of the actual implementation of a type A generic data protection concept
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P014012 - Software library for data protection concept (model A)
Library for developing client and server software for the implemetation of generic data protection concept, model A (provided by the Department of Medical Informatics and Biomathematics at University of Münster)
License and Copyright
The software is published under MIT-License:
Copyright (c) 2010 René Brüntrup, Martin Lablans, Frank Ückert
Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:
The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.
THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.
Downloads
- Documentation (german) [pdf]
- Data Protection Library Version 1.0.2 [zip]
Contact Person:
P015011 - PID generator
Software component for the creation and error-tolerant matching of first-order pseudonyms on the basis of identifying patient data
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P015021 - PID service
Service for saving and administrating patient lists
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P017011 - Informed Consent – Guideline
Harnischmacher U, Ihle P, Berger B, Goebel J, Scheller J: TMF checklist and guidelines on informed consent. Fundamentals and guidance for clinical research, Berlin 2006 (TMF book series, vol. 3)
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P017021 - Informed Consent – Online-Assistent
Software assistant for web-based use of the TMF checklist for creation of patient information and informed consent
Contact Person:
Johannes Drepper
TMF-Geschäftsstelle
030 310119-53
E-Mail
P017031 - Informed Consent - Checklist
Checklist for the compilation of informed consent material
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P019011 - System validation master plan
P019012 - Audit concepts for computer systems
P019013 - System validation – Training documentation
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P020011 - Data quality guideline
P020021 - Statistical tables on data quality
Statistical tables for the data quality guideline in cohort studies and registers
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P020031 - Data quality software
P021011 - SAS macros for clinical studies
TMF macro collection for the SAS software for the evaluation of clinical studies
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P022021 - Legal Opinion on rights of utilisation
Goebel J, Scheller J: Rights of utilisation in networked medical research - Legal opinion on value creation by transfering and processing data in medical research and health care, Berlin 2009 (TMF book series, vol. 7)
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P022022 - Specimen Texts for matters of exploitation
Information and specimen texts on drafting of contracts when transfering knowledge and data between medical research and health care
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P023011 - QM manual for health portals
P024011 - Author portal for guideline development
Access to a web portal with specialized tools for joint creation and consenting of medical guidelines including user support and services
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P027011 - Training documentation for the legal framework of IITs
P028011 - Checklist for the legal framework of IITs
Checklists on carrying out IITs as per the 12th German Medicinal Products Act (‘AMG’) amendment
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P0320xx - SOPs for Clinical Studies
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P034011 - SDTM converter
Software for the transformation of clinical data from CDISC-ODM structures to SDTM format
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P039031 - Legal Opinion on data protection in medical research
Legal Opinion on data protection in medical research, in particular concer-ning the duty of pseudonymisation according to the German Medicinal Products Act (‚AMG‘), the use of health care data as well as the electronic health card, and the relevance of the German Act on Medical Devices (‚MPG‘)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
E-Mail
P042011 - Legal Opinion on electronic archiving
Legal opinion on electronic storage of documents and data files in the context of clinical trials
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P042021 - Expert Opinion on conventional file formats for electronic archiving
Expert opinion on the applicability of conventional file formats for electronic archiviung in clincial trials
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
Expert Opinion on the use of CDISC-ODM for electronic archiving - Expert Opinion on the pros and cons of CDISC-ODM for archiving of clinical trial data
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
Expert Opinion on economic aspects of electronic archiving - Expert Opinion costs and benefits of archiving strategies for clincial trial documents
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P046011 - Information booth accessories
Hire of banner displays and accessories for information booths
Contact Person:
Antje Schütt
TMF Office
+49 30 310119-56
E-Mail
P052011 - Legal Opinion on data custodianship
Legal Opinion on data custodianship in networked medical research
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P052012 - Specimen Contract for data custodianship
Checklist and specimen contract for data custodianship in networked medical research
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
P058011 - German Biobank Registry
Online Registry of Biobanks in Germany
Contact Person:
Dr. Roman Siddiqui
TMF Office
+49 30 31 01 19 73
E-Mail
P062011 - Clinical Evaluation, Clinical Studies and HTA for Medical Devices
Training Documents on Medical Device Regulation - Training documents on regulatory requirements for clinical evaluation and clinical trials with medical devices
P999011 - Quiz software
Software for the creation of a quiz to test knowledge, for use at events.
Contact Person:
Antje Schütt
TMF Office
+49 30 31 01 19 56
E-Mail
P999021 - Hosting for SAE software
P999031 - Licence granting for SAE software
Voucher to call up licenses for the SAE management software VigilanceONE on special terms
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P999041 - Assessment of biobanks
Consultation on the creation and implementation of concepts for biobanks by the TMF „Biobanking“ working group
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
E-Mail
P999051 - Assessment of data protection concepts
Consultation on the creation and implementation of data protection con-cepts based on TMF generic data protection concepts by the TMF „Data Protection“ working group
Contact Person:
Johannes Drepper
TMF Office
+49 30 31 01 19 53
E-Mail
P999061 - Expert Opinion on Biobanking in Germany
Expert opinion for the German Parliament: Assessment and characteriza-tion of biobanks – systematization, scientific assessment, financing models and concepts on data protection and informed consent
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 31 01 19 50
E-Mail
P999071 - Specimen contracts - Contracted software developement and cession of utilisation rights
Specimen contracts for the assignment of contracted software development, cession of software and online databases and the formulation of non-disclosure agreements
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P999081 - repliCheckSNP
Software for quality control of snp genotyping data
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P999091 - Supplemental sheet for genotyping data
Template form for the record and the handing-over of accompanying documentary information when passing genotyping data to third parties
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P999101 - Catalogue of fluorescence cluster types
Consensus nomenclature for non-canonical fluorescence clusters of SNPs on Illumina genotyping chips
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P999111 - Report templates for pharmakovigilance software
Templates for generating reports and submission forms for the management of SAEs using VigilanceONE
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail
P999112 - Narrative script for pharmacovigilance software
Script supporting the generation of case narratives for CIOMS reports required for the management of SAEs using VigilanceONE
Contact Person:
Mathias Freudigmann
TMF Office
+49 30 310119-52
E-Mail