What is it? Why is it important?
When wanting to implement a given study idea, various factors must be considered so as to evaluate whether the idea can be implemented in a research setting.
Aspects to consider include:
- Access and availability of study participants at study site?
- Qualified staff?
- Required infrastructure (e.g. offices, patient rooms, storage facilities, laboratories)?
- Access to alternative study sites (e.g. multicentre studies)?
- Adequate financial means to cover the study?
- Ample time at disposal for realising the study?
What do I need to do?
Based on the planned study, define requirements. Decide what factors are present and which ones are missing.
As applicable, clarify access to:
- Site internal/external qualified staff and partners
- Study participants at your site
- Required infrastructure and resources
- Additional study sites and their inclination to participate
- Available funds
Important is also to assess the feasibility of your study design (e.g. how would randomisation procedures be implemented, drugs administered).
For more information refer to Feasibility in this Study Guide.
When recruiting hospital internal/external partners such as alternative study sites, hired service providers, and study staff, you should:
- Perform a feasibility check of any potential collaborating site in order to assess suitability
- Evaluate adequacy of staff qualification and expertise needed to fulfil study tasks and responsibilities (e.g. project manager, study nurse, study coordinator)
- Ensure qualification of hired partners in order to guarantee for the quality of provided services (e.g. certified laboratories, use of a GCP-compliant database, qualified study monitor)
Successful study implementation will depend on the expertise and professionalism of study staff and partners participating or supporting your study.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
SAMS – see in particular
- Research with human subjects
ICH GCP E6(R2) – see in particular guidelines
- 4.2 Adequate resources
- 5.3 Medical expertise
- 5.1 Trial design
- 5.5 Trial management
- 5.6 Investigator selection
- 5.7 Allocation of responsibilities
- ICH Topic E8 – see in particular guidelines
- 2.2 Scientific approach in design and analysis
ISO 14155:2020 Medical devices - see in particular sections (access liable to costs)
- 6.3 Justification for the design of the clinical investigation
- 9 Responsibilities of the sponsor (SP-INV)