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The program supports innovative concepts to facilitate trial associated science. It provides (co)-funding for interventional trials, including pharmacological trials according to AMG, cohort studies, as well as prognostic, diagnostic, and stratification marker trials. This includes first-in-man, pilot, proof-of-mechanism/concept or feasibility studies up to phase IV trials. BIH CRU Clinical Research Call is open to all research areas.

Eligibility and evaluation criteria

Applications bring together clinical research and basic science, preferentially by collaboration between scientists from Charité and MDC. Researchers from Charité and/or MDC who have completed their academic training (a doctorate as a rule) are eligible. Application is possible by a single PI or by a team of investigators. At least one applicant is PI or Co-PI of the proposed clinical trial and has a track record in clinical research.
A primary goal of the funding instrument is to strengthen the BIH/CRU profile and to establish CRU infrastructure. Therefore projects have to contribute to the development of the CRU infrastructure within BIH and should establish structures or resources, which will support BIH scientists beyond the scope of the individual application. Clinical parts of the funded projects have to be perfomed in the BIH Clinical Research Unit (CRU) and in collaboration with BIH Core Facilities (CF).
We explicitly invite early career and female researchers, but also basic scientists to apply and encourage teams wishing to investigate innovative lines of translational research to submit exploratory research proposals. Application is possible for:
a)    clinical trials with Charité or MDC as sponsor (Investigator Initiated Trial (IIT))
b)    Additions to ongoing clinical trials (clinical trial associated science) Evaluation criteria include innovation, relevance to the mission of BIH, contribution to the improvement of the CRU infrastructure, additional external funding, track record of the applicant, added value resulting from the collaboration between clinical research and basic science, preferentially MDC and Charité, establishment of BIH-cohorts, and added value resulting from central use and operation of BIH Core Facilities and the CRU. The projects must comply with the Guidelines on Good Clinical Practice (ICH-GCP) and Good Scientific Practice.

Scope and duration of funding

In the first funding period approximately five projects will be supported. A budget of up to 250,000 Euro per project will be granted for up to 2 years with no-cost extension possible for another year. Projects with budgets exceeding this amount will have to provide a detailed justification based on available co-funding, expected outcome and contribution to the establishment of CRU infrastructure.
The granted budget is intended predominantly for personnel, consumables and fees for the CRU and core facilities as requested in the projects budget plan. Other costs (insurance for patients and/or test persons, payments to patients etc.) will be provided to the applicant directly. Funded personnel will be located at the respective CRU site.

Application process/selection procedure

The application process comprises two stages: Applicants are invited to submit a pre-proposal that consists of a short project outline (approx. 2 pages) and a rough timeline and budget plan plus annexes such as publication list and CVs. You can find the necessary forms on the right. Deadline for submission at the BIH online application portal is 12 August 2015 at 3 pm.
Pre-proposals will be checked for eligibility and quality, emphasizing the translational and systems medicine aspects, novelty and feasibility of the proposed work. Successful applicants were invited to submit a full proposal.
Deadline for the full application is 15 January 2016 at 3 pm. 
Full proposals will be evaluated by external reviewers.  Results of the final evaluation will be announced in March 2016. Funding will be available from April 2016 at the earliest.

Timeline

1 July - 12 August 2015

Call for pre-proposals
13/14 August 2015Formal check of pre-proposals
Beginning of October 2015 Meeting of the review committee and final decision
OngoingCall for full proposals  
February 2016Written evaluations from external & internal reviewers
March 2016Final funding decision by BIH Board of Directors

Kontakt

Kati Jegzentis
Koordinatorin Clinical Research Unit
Tel. +49 30 450 543 029
E-Mail: kati.jegzentis@bihealth.de