Responsible PrecliniX (RPX) - Service Unit

Responsible PrecliniX FAQ

• How to get into contact? Who can contact us?

  We welcome projects from all career stages, from PhD projects to larger European consortia. Write us an email with a short description of your project. You may include a proposal (draft), publication(s), a thesis, or simply bullet points about a potential new project. Importantly, as we are providing this service within the Charité, we are bound by a confidentiality and corporate nondisclosure agreement. We treat all projects with the strictest confidentiality as a matter of course. 

• When should I contact Responsible PrecliniX?

  PhD students, postdocs, principal investigators, or research groups can approach Responsible PrecliniX already at the early stages or at the stage of proposal writing, and subsequently, we accompany projects from the basic idea to translation through a series of Go/No-Go decision points. A funded project can receive counseling for improvements in experimental design, how to design a replication study (sample size, additional drug concentrations, etc.), or best practices for engaging other labs to conduct external replications. 

• How will my project be assessed and evaluated?

  You are the expert in your specific research field. Consequently, we do not interfere with the scientific question and do not provide a scientific review. Instead, we aim at complementing your academic expertise with expertise in statistics (including sample size calculation), experimental design, experimental models (including potential alternatives), robustness, and the role or need of replication studies (within a laboratory or between laboratories) and meta-research (e.g., systematic review methodology).

  To assess your project, we use a standardized question catalogue to assess the robustness of your project. 

  Based on this first assessment, we will schedule a meeting with you. In this meeting, we will deepen our understanding of your needs and collaboratively identify action items. The evaluation can be helpful (i) to improve and strengthen the validity and reliability of the study, (ii) to find collaborators and (iii) to identify and define go/no go decision points including preclinical endpoints. The continuation of the support beyond this first meeting, including the articulation of the contact with Core Units or regulatory affairs representatives, will be planned and personalized for each project. 

• What is the focus of the support provided?

  We would like to support you with guidance, practical support and useful tools to improve the quality and robustness of your research results in the laboratory.Our counseling sessions are focused on four aspects of the study design: internal validity (e.g., risk of bias), reliability (e.g., general statistical aspects, consistency), external validity (e.g., generalizability across preclinical settings), and translational validity (e.g., the similarity of the preclinical model to human population). In addition, we ask basic questions regarding regulatory affairs and quality assurance to connect projects with other units (e.g., Core Units, Regulatory Affairs), depending on specific needs. We can also assist you with the animal permit and/or pre-registration.

• What type of preclinical research is supported?

  We provide counseling and support for all basic and preclinical research projects that aim at clinical translation i.e., the pathway from biomedical discovery to patient benefit. We support in vitro, ex vivo as well as in vivo models. The support available is not restricted to pharmacological interventions or drug development, but also covers surgical procedures, medical devices or studies that focus on gaining mechanistic understanding and/or target validation. 

• What type of projects are supported?

  We welcome projects of all types and sizes – from basic discovery research (if the long-term goal is translation) to applied translational research, from PhD projects to EU consortia. Depending on the specific needs of the project and overall demands from the unit, we will scale our contributions accordingly, always ensuring that support is given to every project.

• What is the evidence base for the process initiated by Responsible PrecliniX?

  The metric (that means, our questions catalog) was initially developed based on our experience with a pioneering project BMBF Call for confirmatory preclinical trials and use cases within BIH programs, such as SPARK and (Junior) Clinician Scientist Program. The metric and consultation are under continuous evaluation and are constantly refined based on meta-research projects and feedback from researchers like yourselves. 

• Are there any associated costs?

  Responsible PrecliniX is implemented into the BIH strategy and resulted in a permanent position to safeguard its continued existence. To further ensure sustainability, the first evaluation and counseling session will remain free to use at the point of access.

  However, to ensure additional funding we apply for (third party funded) projects that focus on conducting research on research. Responsible PrecliniX is recognized by local organizations like Charité 3R. In this context, Charité 3R appoints Responsible PrecliniX to provide methodological support and accompany projects of an upcoming funding scheme. In addition, to secure funding, we can be acknowledged by you as a cooperation partner and/or co-applicant in funding schemes to promote high quality standards and enable research on research.

• Do you provide support in implementing Quality Assurance Measures or a whole Quality Management System?

  With close cooperation between Responsible PrecliniX and PREMIER PREMIER, we also offer advice on questions at research laboratory level relating to the introduction of quality assurance measures. 

  PREMIER supports you in questions regarding the standardization of methods (introducing SOPs), the documentation of research results (ELN, research Wiki), the implementation of study design (providing templates), the preregistration of experiments / projects, questions regarding open access and open data, the systematic handling of errors (introducing LabCIRS) and much more. If required, PREMIER can also be introduced as a complete quality management (QM) system.

  Do not hesitate to contact us for further information.