P042041 - Expert Opinion on economic aspects of electronic archiving
 
Expert Opinion costs and benefits of archiving strategies for clincial trial documents
Contact Person:
Sebastian C. SemlerT
MF Office
+49 30 310119-55
E-Mail
 
 
P042031 - 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:
Sebastian C. Semler
TMF Office
+49 30 310119-55
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:
Sebastian C. Semler
TMF Office
+49 30 310119-55
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:
Dr. Ulrich Gauger
TMF Office
+49 30 310119-83
E-Mail
 
 
P999111 - Report templates for pharmakovigilance software
 
Templates for generating reports and submission forms for the management of SAEs using VigilanceONE
Contact Person:
Dr. Ulrich Gauger
TMF Office
+49 30 310119-83
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:
 
 
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:
Kerstin Bockhorst
TMF Office
+49 30 310119-52
E-Mail
 
 
P999031 - Licence granting for SAE software
 
Voucher to call up licenses for the SAE management software VigilanceONE on special terms
Contact Person:
Saskia Mowinski
TMF Office
+49 30 310119-79
E-Mail
 
 
P999021 - Hosting for SAE software
 
TMF
hosting service for the use of SAE management software VigilanceONE via
remote access (ASP)
Contact Person:
Saskia Mowinski
TMF Office
+49 30 310119-79
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
 
 
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
 
 
P042011 - Legal Opinion on electronic archiving
 
Legal opinion on electronic storage of documents and data files in the context of clinical trials
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 310119-55
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
 
 
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
 
 
P019013 - System validation – Training documentation
 
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
 
 
P019012 - Audit concepts for computer systems
 
Contact Person:
Johannes Drepper
TMF Office
+49 30 310119-53
E-Mail
 
 
P019011 - System validation master plan
 
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
 
 
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
 
 
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
 
 
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
 
 
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