Muenchner Studienzentrum (TUM-MED)

Muenchner Studienzentrum

The Muenchner Studienzentrum (MSZ) is the central core facility for all disciplines at the Medical School of Medicine of the Technical University of Munich (TUM). Together with the Institute for Medical Informatics, Statistics and Epidemiology (IMedIS), TUM, it forms a highly experienced cooperation unit which is dedicated to offer comprehensive clinical research solutions for investigator-initiated trials (IITs) as well as industry- sponsored clinical trials by promoting their quality and efficiency in accordance with national and international guidelines. The MSZ is member of the German network "Koordinationszentren für Klinische Studien (KKS)", an academic research network and of the international clinical trial networks “International Clinical Trials Network, ICN” and “European Clinical Research Infrastructure Network, ECRIN.

 

Roles and tasks of TUM-MED in SVDs@target

The Muenchner Studienzentrum will contribute its services as an acedemic research organisation for IITs to WP5 (Validation of Mechanisms through Interventions). Tasks of the MSZ comprise project planning (aspects of study design and finances), organisational project management (i.e. development and actualization of study documents including protocol and informed consent, international regulatory affairs, international ethics committees, recruitment supervision, protocol adherence, communication and reporting, sponsors legal responsibilities), data management (i.e. development of electronic case report forms and data base, data quality assurance), safety management (i.e. development of safety data base, processing of serious adverse events, MedDRA-coding of adverse events, annual safety reports to ethics committees and competent authorities) and quality assurance (i.e. monitoring of study data at participating study sites, providing of  SOPs).

Key staff

Dr. Silvia Egert

 

Dr. Egert (PhD) is project manager especially of large multicenter trials and the head of business development of the MSZ. She has longstanding (>15 year) experience in conducting clinical trials and has been partly responsible for the development of the MSZ. She contributes to project planning and will support project management of the clinical trial "TREAT-SVDs".

 

SVD@target team at TUM

Dr. Elisabeth André

Project Management, Monitoring

Dr. André (PhD) is the head of the monitoring unit of the MSZ. She has longstanding experience as a clinical project manager and clinical research associate including international trials and is well-experienced in coordinating, monitoring and managing clinical trials according to international guidelines. Dr. André is member of the KKS-working group "Monitoring" and will coordinate the monitoring of the clinical trial.

 

Dr. Alfred Zollner

Data and Safety Management

Dr. Alfred Zollner (PhD) is the vice director of the MSZ and the head of the combined data- and safety- management unit. He will be involved in the supervision of both tasks in the clinical trial. Dr. Zollner is member of the KKS-working group "Data Management".

 

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Tweets by SVDS@target

Publications with PubMed ID

Authors: Ratelade J, Klug NR, Lombardi D, Angelim MKSC, Dabertrand F, Domenga-Denier V, Al-Shahi Salman R, Smith C, Gerbeau JF, Nelson MT, Joutel A

Circulation. 2020 Mar 18;

PMID: 32183562

Authors: Li Q, Aalling NN, Förstera B, Ertürk A, Nedergaard M, Møllgård K, Xavier ALR

Fluids and barriers of the CNS. 2020 Feb 11;17(1):15

PMID: 32046744    Open Access: PMC7014736

Authors: Georgakis MK, Malik R, Anderson CD, Parhofer KG, Hopewell JC, Dichgans M

Brain : a journal of neurology. 2020 Feb 1;143(2):597-610

PMID: 31968102    Open Access: PMC7009571

Authors: Sloots JJ, Biessels GJ, Zwanenburg JJM

NeuroImage. 2020 Apr 15;210:116581

PMID: 31982580

Authors: Mestre H, Du T, Sweeney AM, Liu G, Samson AJ, Peng W, Mortensen KN, Stæger FF, Bork PAR, Bashford L, Toro ER, Tithof J, Kelley DH, Thomas JH, Hjorth PG, Martens EA, Mehta RI, Solis O, Blinder P, Kleinfeld D, Hirase H, Mori Y, Nedergaard M

Science (New York, N.Y.). 2020 Mar 13;367(6483)

PMID: 32001524

Authors: Abraham G, Malik R, Yonova-Doing E, Salim A, Wang T, Danesh J, Butterworth AS, Howson JMM, Inouye M, Dichgans M

Nature communications. 2019 Dec 20;10(1):5819

PMID: 31862893    Open Access: PMC6925280