CTU Bern (Clinical Trials Unit)

News 2016

Financial support for research databases of the Inselspital

As of 1.1.2017, CTU Bern will again be able to give a discount for research databases of the Inselspital Bern. The discount amounts to up to CHF 3’000.- per study and can be used for studies that are not industry sponsored. The funds are taken from the core funding that the CTU Bern receives from the Direktion Lehre und Forschung (DLF) of the Inselspital. Insel researchers can find details on the funding on the Insel Intranet.

OPERAM trial now open for recruitment

The OPERAM trial funded by a HORIZON 2020 grant started recruitment this week at the Department of Internal Medicine at the Inselspital Bern.

Read more

ICH adopted the Integrated Addendum to the Good Clinical Practice (GCP) Guideline

On November 30th, 2016 the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the adoption of the Integrated Addendum to the Good Clinical Practice (GCP) Guideline E6(R2). ICH states that the “guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results”. The amendment will now be implemented by ICH members through national and regional guidance. Read more.

Central Data Monitor (60 - 100%)

As Central Data Monitor at CTU Bern, you will be a part of the Quality Assurance and Monitoring workflow.

Clinical Research Associate (Monitor/in) 80-100%

Zur Verstärkung unseres Teams suchen wir per 1. Dezember 2016 oder nach Vereinbarung eine/n Clinical Research Associate (Monitor/in) 80-100%.

Clinical Data Manager (60-80%)

To reinforce the existing team we are currently looking for a Clinical Data Manager (60-80%).

To reinforce the existing team we are currently looking for a Clinical Data Manager (60-80%).

New member of staff: Marie Roumet

After completing her studies in biology and ecology with a focus on genetics and biostatistics at the University of Montpellier, Marie completed a PhD in plant biology. Afterwards, she worked as a postdoctoral researcher at the ETH Zürich for more than 4 years. She joined CTU as a Senior Statistician and will replace Roger Schürch who will be leaving CTU soon taking on a position as assistant professor at Virginia Tech, Blacksburg/VA.

New Certificate of Advanced Studies in Clinical Epidemiology

21.11.2016 - The University of Bern offers a new Certificate of Advanced Studies in Clinical Epidemiology. Participants will learn the necessary methods to plan, conduct and communicate clinical research projects.
Click to read more.

Call for Entries: SPRINT Data Analysis Challenge

In order to demonstrate the potential benefits of clinical trial data sharing and transparency, the New England Journal of Medicine (NEJM) has launched the SPRINT Data Analysis Challenge. The Challenge encourages healthcare professionals, researchers and scientists from around the world to use the dataset underlying the SPRINT report, plus any other publicly available dataset, to identify a novel scientific or clinical result. Read more

Recommendations for the construction and use of health-related registers

Registers with reliable data are becoming increasingly important in the healthcare sector. To contribute to the quality assurance, the organizations ANQ, FMH, H+, SAMW and unimedsuisse have jointly published recommendations for the construction and use of health-related registers. These include minimum standards for example on data protection and data quality. You can find The recommendations here.

Umfrage zur Einreichung über BASEC

swissethics ist interessiert an Ihrem Feedback zur Einreichung neuer Forschungsprojekte über BASEC.
swissethics hat dazu eine Umfrage gestartet, die Sie hier ausfüllen können.

CTU Newsletter September 2016

28.10.16
- IICT call: Drei erfolgreiche Projekte am Inselspital
- Die CI zieht um!
- Praktikum an der Clinical Investigation
- Ethikeinreichung via BASEC
- Neuer GCP Modulkurs
- Die nächsten Kurstermine und CTU Lectures
 

New template for Annual Safety Report of IITs available

26.10.16 - Swissethics has published a new template of the Annual Safety Report for Investigator initiated trials (IITs) under the Clinical Trials Ordinance (ClinO). The template can be found and downloaded on the website of swissethics.

Read more

Lessons Learned

Lessons Learned

25.10.16 - What is a Site Delegation & Signature Log and what purpose does it serve? Read more

SNSF issues second call for Investigator initiated clinical trials (IICT)

04.08.16 - The Swiss National Science Foundation has issued the second call for Investigator initiated clinical trials (IICTs). Researchers wishing to apply for funding within the IICT programme have to submit their letter of intent by 1 September 2016. Read more

 

First IICT call: Three approved projects at the Inselspital Bern

22.07.16 - In August, the SNSF has launched the first call for independent, Investigator Initiated Clinical Trials (IICTs). With three approved applications, the clinical researchers at the Inselspital Bern have been highly successful. CTU Bern closely collaborates with the Inselspital in two approved projects. Read more

GCP Refresher course on 7th of June

25.05.16 - On Tuedsay, June 7th 2016, CTU Bern offers a free half day course at the Inselspital for GCP certificate holders, who wish to refresh and update their good clinical practice knowledge.

All important information can be found here.

Results of CTU customer survey now available!

23.03.16 - In January and February 2016, CTU Bern conducted a survey among customers from the Inselspital. The results of this survey are now available. Read more

SCTO Symposium 2016:
Building up the future generation of clinical researchers

29.04.16 - Leading experts and stakeholders will discuss on 16 June 2016 in Lausanne the current opportunities and challenges as well as future perspectives to promote young physicians in the field of clinical research. Register now! Read more

The Lancet: Paracetamol ‘not clinically effective’ in treating osteoarthritis pain or improving physical function

Source of the following press release: The Lancet journals, London - 17.03.2016

In a large-scale analysis of pain-relief medication for osteoarthritis, researchers find that paracetamol does not meet the minimum standard of clinical effectiveness in reducing pain or improving physical function in patients with knee and hip osteoarthritis. Although paracetamol was slightly better than placebo, researchers conclude that, taken on its own, paracetamol has no role in the treatment of patients with osteoarthritis, irrespective of dose. Read more

Tocilizumab effective for patients with giant cell arteritis

21.03.2016 - Giant cell arteritis is an immune-mediated disease of medium and large-sized arteries that affects mostly people older than 50 years of age. The study aimed to assess the efficacy and safety of tocilizumab in the first randomised clinical trial in patients with newly diagnosed or recurrent giant cell arteritis. Read more

CTU Lecture am 8.3.2016:
«Praktische Tipps und Hinweise zur Studienregistrierung»

07.03.16 - Sven Trelle, Kodirektor der CTU Bern, informiert Sie an der kommenden CTU Lecture über die wichtigsten Dos and Don'ts sowie die gesetzlichen Rahmenbedingungen, die Sie bei der Registrierung von klinischen Studien beachten sollten.

Die Folien zur Präsentation von Sven Trelle finden Sie hier.

Have your own Study Website

02.03.16  - The CTU Bern Data Management Team is offering a new service to support your study or project.

Whether to promote your study, to provide information to patients or to communicate with your sites, a website is a great tool to reach your target audiences. We can help you to establish your own project Website based on our pre-selected WordPress Templates with minimal costs. Feel free to contact us to discuss further about your future study/project website. For more information, click here.

Umfrage am Inselspital:

Ihr Feedback zählt!

05.02.16 - Die CTU Bern ist bestrebt, den klinisch Forschenden am Inselspital bestmögliche Unterstützung bei Ihren Studienprojekten bieten zu können und das Dienstleistungsangebot entsprechend den Bedürfnissen weiter zu optimieren:
Durch die Umfrage wollen wir herausfinden, wie zufrieden Sie mit unseren Dienstleistungen und Mitarbeitenden sind und in welchen Bereichen wir uns weiter verbessern können, um die patientenorientierte klinische Forschung am Forschungsplatz Bern noch gezielter zu fördern.
Wir bitten Sie, sich 10 Minuten Zeit zu nehmen und an unserer Online-Befragung teilzunehmen: Hier geht's zur Umfrage.

Vielen Dank!

CTU Lecture am 2.2.2016: «Forschungsverträge: Was gilt es zu beachten?»

27.01.16 - Dr. sc. nat. ETH Daniel Gisi, Technology Transfer Manager bei Unitectra, der Technologietransfer-Organisation der Universitäten Basel, Bern und Zürich stellt in seinem Referat Typen von Forschungsverträgen vor, die am Inselspital abgeschlossen werden und gibt wertvolle Tipps, worauf bei der Aushandlung von Verträgen geachtet werden muss.
In der anschliessenden Diskussion können Sie Ihre Fragen stellen und eigene Erfahrungen mit dem Experten und den anwesenden Kolleginnen und Kollegen austauschen.
Wir freuen uns auf Ihre Teilnahme!

Die Folien zur Präsentation von Herrn Dr. Gisi finden Sie hier.

CTU Lecture am 12.1.2016:
«KEK Anträge: Wie reiche ich einen KEK Antrag korrekt ein? - Tipps und Tricks von der KEK Generalsekretärin»

05.01.2016 - Wir freuen uns, Ihnen das Referat von Frau Dr. sc. nat. Dorothy Pfiffner, Leiterin des Sekretariats der Kantonalen Ethikkommission Bern KEK, ankündigen zu dürfen: Am 12. Januar 2016 wird Frau Dr. Dorothy Pfiffner im Rahmen der CTU Lectures über häufige Rückstellungsgründe von Forschungsanträgen berichten sowie über die wichtigsten Anforderungen und Bedingungen der KEK referieren. Die CTU Lecture bietet Ihnen zudem die Gelegenheit, Fragen und Anliegen rund um das Thema Anträge der KEK direkt zu kommunizieren. Die Teilnahme ist kostenlos und ohne Voranmeldung möglich.

Weitere Informationen finden Sie hier.