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. multi-centre studies)?
- Adequate financial means to cover the study?
- Ample time at disposal for realising the study?
What do I need to do?
As a SP-INV, 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 the study site
- Required infrastructure and resources
- Additional study sites and their inclination to participate (e.g. Site-INV)
- Available funds
Important is also to assess the feasibility of your study design (e.g. how would randomisation procedures be implemented, drugs administered).
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, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
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 (R1) – see in particular guideline
- 2.2 Scientific approach in design and analysis
ISO 14155:2020 Medical devices (access liable to costs) - see in particular sections
- 6.3 Justification for the design of the clinical investigation
- 9 Responsibilities of the sponsor (SP-INV)
SAMS – see in particular handbook
- Research with human subjects