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Project-management services other than for construction work.

Contract award: project management services in connection with the testing of examination and treatment methods according to A* 137e sgb v.

Subject matter of the contract awarded are project management services in connection with the testing of examination and treatment methods according to A* 137e SGB V. 137e Under A* SGB V, the Federal Joint Committee (G-BA) in the examination of examination and treatment methods according to A* 135 SGB V or A* 137c SGB V under suspension of its advisory procedure to test a policy decide when he comes to the conclusion that a method has the potential of a necessary treatment option, the benefits are not yet sufficiently proven. The aim is to gain the necessary knowledge needed for assessing the usefulness of the method. Due to the Directive, the examination or treatment is provided in a limited period as part of the medical treatment or early detection at the expense of health insurance.

Furthermore, according to A* 137e paragraph 7 SGB V - regardless of a consultation process under A* 135 SGB V or A* 137c SGB V - manufacturer of a medical device on its use, the technical application of a new examination or treatment method is largely based, and companies in otherwise as provider of a new method have an economic interest in a provision at the expense of health insurance, ask the G-BA that this resolves a directive to test the new method.

For the scientific monitoring and evaluation of the trials of the G-BA commissioned a professionally independent scientific institution.

After Chapter 2 A* 24 of the Rules of Procedure (Rules of Procedure) of the G-BA will establish a project management for the trials. The project management support to the G-BA in the sense of a project sponsored technical and administrative tasks in all phases of the testing. This includes in particular

- The invitation to tender and the award of the contract management of the study conduct to an academic institution in accordance with Chapter 2 A* 25 of the Rules of Procedure of the G-BA,

- The review of the study protocol and implementing steps for compliance with the requirements of the Erprobungs Directive,

- The ongoing review of the financing according to the requirements in accordance with Chapter 2 A* 26 Rules of Procedure of the G-BA,

- The preparation of reports on the performance of his duties,

- As well as the support of the G-BA in the performance of its duties pursuant to A* 137e SGB V.

Date of contract award decision: 26.6.2014

Contractor name : DEUTSCHES ZENTRUM FE[pounds sterling]R LUFT- UND RAUMFAHRT E. V. PROJEKTTREaGER IM DLR

Contractor address : Heinrich-Koenen-StraE-e 1

53227 Bonn

GERMANY

Agency : Gemeinsamer Bundesausschuss G-BA

WegelystraE-e 8

For the attention of: Herrn Gutekunst

10623 Berlin

GERMANY

Internet address(es):

General address of the contracting authority: www.g-ba.de

country :Germany

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Publication:Mena Report
Date:Aug 6, 2014
Words:484
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